Interventional procedure overview of bioresorbable stent implantation to treat coronary artery disease

Ali ZA, Serruys PW, Kimura T et al. (2017) 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet; 390:760−72.

Systematic review and meta-analysis of randomised trials 

n=5583 patients assigned to Absorb BVS (n=3261) or metallic EES (n=2322) and followed up for 2 years.

BVS had higher 2-year relative risks of the DOCE than did EES (9·4% [304 of 3217] vs 7·4% [169 of 2299]; RR 1·29 [95% CI 1·08-1·56], p=0·0059). These differences were driven by increased rates of target vessel MI (5·8% [187 of 3218] vs 3·2% [74 of 2299]; RR 1·68 [95% CI 1·29-2·19], p=0·0003) and ischaemia-driven TLR (5·3% [169 of 3217] vs 3·9% [90 of 2300]; 1·40 [1·09-1·80], p=0·0090) with BVS, with non-significant differences in cardiac mortality. The cumulative 2-year incidence of device thrombosis was higher with BVS than with EES (2·3% [73 of 3187] vs 0·7% [16 of 2281]; RR 3·35 [95% CI 1·96-5·72], p<0·0001).

Large and recent studies included.

Ali ZA, Gao R, Kimura T et al. (2018) Three-year outcomes with the Absorb bioresorbable scaffold: individual-patient-data meta-analysis from the

ABSORB randomized trials. Circulation; 137:464−79.

Meta-analysis of 4 RCTs assigning patients to an Absorb BVS (n=2164) or a DES (n=1225).

Individual-patient-data meta-analysis of 3 year outcomes of ABSORB versus Xience from the ABSORB RCTs showed higher rates of TLF (11.7% versus 8.1%; RR, 1.38; 95% CI, 1.10–1.73;P=0.006), driven by greater target vessel MI (7.8% versus 4.2%; RR, 1.72; 95% CI, 1.26–2.35; p=0.0006) and ischemia-driven TLR (6.6% versus 4.4%; RR, 1.44; 95% CI, 1.05–1.98; P=0.02), with comparable cardiac mortality (1.1% versus 1.1%; RR, 0.93; 95% CI, 0.47–1.88; P=0.85). Device thrombosis rates through 3 years were also higher with BVS (2.4% versus 0.6%; RR, 3.71; 95% CI, 1.70–8.11; P=0.001).

Large and recent studies included.

Alfonso F, Cuesta J, Pérez-Vizcayno MJ et al. (2017) Bioresorbable vascular scaffolds for patients with in-stent restenosis: the RIBS VI study. JACC: Cardiovascular Interventions. 10: 1841-1851.

Prospective multi-centre study RIBS VI

n=141 patients treated with BVS for either BMS-ISR or DES-ISR.

The study suggested that the use of BVS in patients with ISR was effective and safe. In this challenging anatomic scenario, BVS obtained late angiographic and clinical results similar to DEB but inferior to EES.

Large and recent studies included.

Anadol R, Lorenz L, Weissner M, et al. (2017) Characteristics and outcome of patients with complex

coronary lesions treated with bioresorbable scaffolds: three years follow-up in a cohort of consecutive patients. Eurointervention;03:03.

Observational study (registry) (NCT02180178)

n= 657 patients with BRS implantation in complex lesions.

Median follow-up was 1,076 (762-1,206) days.

BRS implantation in complex lesions is, as expected, associated with higher incidence of events as compared to simple ones. The technique used at the time of the implantation, however, reduces the incidence of adverse outcomes.

Larger studies included.

Aaroyo D, Gendre G, Schukraft S et al. (2017) Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: Two-year clinical outcomes of the EVERBIO II trial. International Journal of Cardiology 243; 121–125.

RCT EVERBIO II trial

N=240 patients

(1:1 e (Comparison of DES with ABSORB BVS)

Follow-up 2 years

The current analysis shows no significant differences with regard to clinical outcomes at 2 years between BVS and the best-in-class metallic DES. Event rates were numerically higher in BVS-treated patients. However, when BVS were compared to BES alone, the occurrence of device related adverse events was significantly increased.

Included in systematic reviews and HTA.

Azzi N, Shatila W (2021) Update on coronary artery bioresorbable vascular scaffolds in

percutaneous coronary revascularization. Rev. Cardiovasc. Med. 22(1), 137-145.

Review

In this review, we discuss the

clinical procedural and technical evidence on BVS, with emphasis on their clinical impact. We finally tackle the future directions on device and procedural improvement while asking: is the bioresorbable technology still the way to the future?

Review

Abizaid A, Ribamar Costa J, Bartorelli AL, et al. (2015) The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention; 10: 1396-1401.

Registry ABSORB EXTEND study

N=512

Follow-up 12 month.

12-month MACE 4.3

showed that minor routine oversizing of the BVS followed by high pressure post-dilatation was safe with a low rate of MACE and no reported stent thrombosis.

Larger and more recent studies included.

Abizaid A, Costa RA, Schofer J et al. (2016) Serial multimodality imaging and 2-year clinical outcomes of the novel desolve novolimus-eluting bioresorbable coronary scaffold system for the treatment of single de novo coronary lesions. JACC: Cardiovascular Interventions; 9: 565-

574.

Case series

N=126 treated with 150 lm thickness pBRS.

The first series of the DESolve showed a LLL at 6 months of 0.19 ± 0.19 mm, which was similar to that seen with contemporary DES. The second series of the DESolve was assessed in the DESolve Nx trial. LLL at 6 months was 0.20 ±

0.32 mm; MACE rate at 24 months was 7.4%. No definite ScT were seen.

Larger and more recent studies included.

Bennet J, Hemptinne QE, McCutcheon K et al (2019) "Magmaris resorbable magnesium scaffold for the treatment of coronary heart disease: overview of its safety and efficacy" Expert review of medical devices. 757-769.

Review of sirolimus-eluting resorbable magnesium scaffold Magmaris

The first clinical studies testing this device in a small number of patients have shown promising results with good clinical and safety outcomes up to 3 years' clinical follow-up, supporting the use of Magmaris in simple CAD.

Large and recent studies included.

Bennet J, McCutcheon K (2020) "The coronary resorbable magnesium scaffold Magmaris: What we've learnt (so far...)" Minerva Cardioangiologica 69(2):215-221.

Review

Review focuses on the resorbable magnesium scaffold Magmaris^® the only metallic bioresorbable scaffold currently available, providing an evaluation of the most up to date clinical data whilst also briefly highlighting learning points regarding the ideal patient and lesion choice and optimal implantation technique.

Large and recent studies included.

Banach M, Serban MC, Sahebkar A et al. (2016) Comparison of clinical outcomes between bioresorbable

vascular stents versus conventional drug-eluting and metallic

stents: a systematic review and meta-analysis. EuroIntervention;12:

e175-e189.

Systematic review and meta-analysis.

10 studies with 5,773 subjects

With BRS and conventional stents

Follow-up in the included studies was up to 13 months.

Our meta-analysis suggests a significantly higher risk of TVMI with BRS compared with conventional stents and no significant differences in the rates of occurrence of the other outcomes during 1-year follow-up. Further studies with larger samples sizes, longer follow-up, different clinical scenarios and more complex lesions are required to confirm or refute our findings

More recent comprehensive studies included.

Baquet M, Hoppmann P, Grundmann D et al. (2019) Sex and long-term outcomes after implantation of the Absorb bioresorbable vascular scaffold for treatment of coronary artery disease. EuroIntervention;15:615-622

Pooling the individual patient data of the ISAR-ABSORB and KUM-ABSORB registries.

of 1,032 patients, 259 (25.1%) were women.

Follow-up 2 years.

BVS used in a routine setting tend to perform better among women compared to men, which might be partially related to the lower complexity of their CAD.

Larger studies included.

Bruining N, Tanimoto S, Otsuka M et al. (2008) Quantitative multi-modality imaging analysis of a bioabsorbable poly-L-lactic acid stent design in the acute phase: a comparison between 2- and 3D-QCA, QCU and QMSCT-CA. Eurointervention 4: 285-291.

Case series

N = 16

Follow-up: Post-procedure only

Authors conclude that non-invasive multi-slice computed tomography coronary angiography could be used to quantify luminal dimensions in PLLA biodegradable stents.

Sub-study. Focus on imaging outcomes.

Bruining N, de Winter S, Roelandt JRTC et al. (2010) Monitoring in vivo absorption of a drug-eluting bioabsorbable stent with intravascular ultrasound-derived parameters. A Feasibility study. JACC: Cardiovascular Interventions 3 (4): 449-456.

Case series

N = 12

Follow-up: 2 years

Authors conclude that quantitative differential echogenicity can be useful for monitoring the absorption process of semi-crystalline bioabsorbable stents.

Sub-study. Focus on imaging outcomes.

Brugaletta S, Radu MD, Garcia-Garcia HM et al. (2012) Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: Can the scaffold cap the plaque? Atherosclerosis 221: 106-112.

Case series

N = 58

Follow-up: 12 months

Authors conclude that the neointimal thickness did not differ between 6 and 12 months but thickness was more symmetric at 12 months.

Sub-study. Focus on imaging outcomes.

Brugaletta S, Gori T, Low AF et al. (2015) Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv; 8: 189–197.

Propensity score matching comparison

n=290 STEMI patients treated by BVS, compared with either 290 STEMI patients treated with EES or 290 STEMI patients treated with bare-metal stents (BMS) from the EXAMINATION trial.

Follow-up 1 year.

At 1-year follow-up, STEMI patients treated with BVS showed similar rates of DOCE compared with STEMI patients treated with EES or BMS, although rate of scaffolds thrombosis, mostly clustered in the early phase, was not negligible. Larger studies with longer follow-up are needed to confirm our findings.

Large and recent studies included.

Brugaletta S, Gomez-Lara J, Garcia-Garcia HM et al. (2012) Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold. International Journal of Cardiovascular Imaging 28: 1307 – 1314.

Case series

N = 17

Follow-up: 1 year

Authors conclude that there was an increase in plaque area with a reduction in necrotic core and dense calcium content.

Sub-study of ABSORB Cohort B2. IVUS-VH outcomes.

Brugaletta S, Gomez-Lara J, Serruys PW et al. (2011) Serial in vivo intravascular ultrasound-based echogenicity changes of everolimus-eluting bioresorbable vascular scaffold during the first 12 months after implantation. Insights from the ABSORB B trial. JACC: Cardiovascular Interventions 4 (12): 1281-1289.

Case series

N = 63

Follow-up:12 months

Authors conclude that there was a 15% and 20% decrease in hyper echogenicity at 6 and 12 months respectively. No difference in hyper echogenicity changes were seen between the proximal, medial, or distal part of the scaffolded segment.

Sub-study. Focus on imaging outcomes.

Brugaletta S, Garcia-Garcia HM, Garg S et al. (2011) Temporal changes of coronary artery plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold. International Journal of cardiovascular Imaging 27: 859 – 866.

Case series

N = 15

Follow-up: 6 months

Authors conclude that there was progression of necrotic core and fibrous tissue content of plaque behind the struts in those having a BVS.

Sub-study. Focus on imaging outcomes.

Brugaletta S, Gomez-Lara J, Bruining N et al. (2011) Head to head comparison of optical coherence tomography, intravascular ultrasound echogenicity and virtual histology for the detection of changes in polymeric struts over time: insights from the ABSORB trial. EuroIntervention 8 (3): 352-358.

Case series

N = 35

Follow-up:12 months

Authors conclude that changes in the BVS struts were detectable by OCT, echogenicity and IVUS virtual histology although there was poor correlation.

Sub-study. Focus on imaging outcomes.

Brugaletta S, Cequier A, Alfonso F, et al. Magnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):64-70.

RCT

N=148 in ST-STEMI patients

SES versus BRS

This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.

Rationale and study design.

Brugaletta S, Garcia-Garcia HM, Diletti R e al. (2011) Comparison between the first and second generation bioresorbable vascular scaffolds: a six month virtual histology study. EuroIntervention 6: 1110-1116.

Comparative case series

N = 28 (BVS 1.0) versus 32 (BVS 1.1)

Follow-up: 6 months

Authors conclude that BVS 1.1 was more durable than the BVS 1.0.

Sub-study. Focus on imaging outcomes.

Brugaletta S, Gomez-Lara J, Diletti R et al. (2012) Comparison of in vivo eccentricity and symmetry indices between metallic stents and bioresorbable vascular scaffolds: insights from the ABSORB and SPIRIT trials. Catheterization and Cardiovascular Interventions 79: 219-228.

N= 242 patients (BVS 1.0: n = 28, BVS 1.1: n = 94, XIENCE V: n = 120).

Follow-up: 6 months

In 28 patients with (BVS 1.0; MACE 3.5%), 94 (BVS 1.1; MACE 4.2%) versus 120 (DES; MACE 1.9%). No differences in MACE were detected between the groups according to their geometrical parameters. No further analysis on clinical outcomes was reported.

Authors conclude that the BVS had a lower eccentricity index and a higher symmetry index but that these differences did not generate clinical events.

Sub-study. Comparative study of mainly imaging outcomes.

Brugaletta S, Heo J-H, Garcia-Garcia HM et al. (2012) Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative therapy? European Heart Journal 33: 1325-1333.

N= 26

Follow-up: 2 years

Authors report that vasodilatory response of a BVS segment was associated with decreased echogenicity over time, and a low amount of necrotic core.

Sub-study. Focus on imaging outcomes.

Capodanno D, Gori T, Nef H, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015; 10: 1144-1153

GHOST-EU registry

N=1189 patients who had angioplasty with the Absorb BVS

The only independent predictor of TLF was diabetes (HR 2.41, P = 0.006) and TLF occurred at a rate of 4.4% at 6 months. The cumulative incidence for definite or probable ScT was concerning with 1.5% at 30 days and 2.1% at 6 months. Independent predictors in this registry included ostial lesions (P = 0.049) and impaired left ventricular ejection fraction (P = 0.019).

Large and recent studies included.

Chevalier B, Cequier A, Dudek D, et al. (2018) Four-year follow-up of the randomised comparison

between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic

stent for the treatment of coronary artery stenosis (ABSORB II Trial). Eurointervention; 13(13):1561–4.

RCT

Absorb BVS II

N=501 (335 versus

166) Everolimus-eluting BRS/Absorb® versus

DES/Xience®

Follow-up 4 years.

TLF (or the DOCE) increased from 10.5% to 11.5% in the Absorb arm and from 5% to 6% in the XIENCE arm, with 1% and 0.7% absolute difference, respectively (p=0.3). No statistically significant difference could be seen (p=0.063). 2 patients in the Absorb arm and 1 in the XIENCE arm died between 3 and 4 years. The POCE was seen in 23.6% in the Absorb arm and 26.7% in the XIENCE arm (p=0.47). No case of additional very late scaffold/stent thrombosis was noted in either arm between 3 and 4 years, with a 4-year rate of 3% versus 0.0% (p=0.035). DAPT slightly decreased from 29.8% to 25.9% in the Absorb arm and from 27.7% to 21.1% in the XIENCE arm, with no significant difference between the 2 arms.

Included in systematic reviews and HTA added.

Chevalier B, Onuma Y, van Boven AJ, et al. Randomised comparison of a bioresorbable

everolimus-eluting scaffold with a metallic everolimus-eluting stent for ischaemic heart

disease caused by de novo native coronary artery lesions: the 2-year clinical outcomes

of the ABSORB II trial. Eurointervention 2016;12(9):1102–7.

RCT Absorb BVS II

501

(335 versus

166) Everolimus-eluting BRS/Absorb® versus

everolimus-eluting permanent metallic

stent/Xience®

Follow-up 4 years.

At 2 years, the PoCE for the Absorb and XIENCE arms was 11.6% and 12.8% (p=0.70) and the DoCE/TLF was 7.0% and 3.0% (p=0.07), respectively. The hierarchical ID-MACE rate was 7.6% versus 4.3% (p=0.16) and the rate of TVF was 8.5% versus 6.7% (p=0.48). The definite/probable thrombosis rate was 1.5% in the Absorb arm versus 0% in the XIENCE arm (p=0.17). Thirty-six percent and 34% of patients remained on DAPT at 2 years, respectively.

Large and longer follow-up studies included.

Cassese S, Byrne RA, Ju¨ni P et al. (2017) Mid-term clinical outcomes with everolimus-eluting bioresorbable

scaffolds versus everolimus-eluting metallic stents for percutaneous coronary interventions: a meta-analysis of randomized trials. EuroIntervention; pii:

EIJ-D-17-00492. Doi: 10.4244/EIJ-D-17-00492

Meta-analysis

5583 included patients had BRS (n = 3261) or

EES (n= 2322).

Median follow-up was 26.6 months.

Patients treated with BRS versus EES showed higher risk for TLFOR (95% CI) = 1.35 (1.14–1.61), P = 0.005] due to a higher risk of target vessel MI [OR 1.68 (1.21–2.33), P= 0.008] and ischaemia-driven TLR [OR 1.42 (1.14–1.78), P = 0.008]. Patients treated with BRS versus EES showed a higher risk for definite/probable stent/ScT [OR 3.24 (2.34–4.50),

P= 0.0001], most marked in the period beyond 1 year after implantation [OR

4.03 (2.11–7.68); P = 0.003].

Both in-device and in-segment late loss are significantly higher for the Absorb BRS compared with metallic EES.

Large and recent studies included.

Collet C, Asano T, Sotomi Y et al. (2017) Early, late and very late incidence of bioresorbable scaffold thrombosis: a systematic review and meta-analysis of randomized

clinical trials and observational studies. Minerva Cardioangiologica; 65: 32-51.

Systematic review n=16,830 patients treated with ABSORB.

There was 1.8% overall rate of definite or probable stent thrombosis, and the residual diameter stenosis percentage was the only factor associated with stent thrombosis.

More recent studies included.

Collet C, Asano T, Miyazaki Y et al. (2017) Late thrombotic events after bioresorbable scaffold implantation: a systematic review and meta-analysis of randomized clinical trials. European Heart Journal; 38: 2559-2566.

Systematic review meta-analysis of 1730 patients.

24 months follow-up.

There was a higher incidence of DT in patients treated with Absorb BVS compared to those treated with EES, with 92% of the very late ScT occurring in the absence of DAPT. They also had a higher tendency for TLF (OR 1.48; P = 0.09) driven by a greater risk of TVMI and ischemia-driven TLR. No difference was found for cardiovascular mortality.

More recent studies included.

Cortese B, Ielasi A, Romagnoli E, et al. Clinical comparison with short-term follow-up of

bioresorbable vascular scaffold versus everolimus-eluting stent in primary percutaneous

coronary interventions. Am J Cardiol 2015;116(5):705–10.

Italian ABSORB Prospective Registry

N=563 patients with STEMI (comparing 122 with BVS-RAI and 441 PCI with EES)

median of 220-day follow-up.

In this direct prospective comparison, BVS was associated with similar clinical results compared to EES in the STEMI setting. Larger and adequately powered randomised trials are needed to fully assess the potential clinical benefit of BVS versus the current standard of care in patients with STEMI.

Large studies included.

Danzi GB, Bernelli C, Cerrato E. (2020) Outcomes of Optimised Implantation Technique with Bioresorbable scaffolds: A Pooled Analysis of ABSORB-IV and COMPARE-ABSORB Trials. Cardiovasc Revasc Med; 21:559−61.

2 RCTs

Pooled analysis of ABSORB-IV and COMPARE-ABSORB trials.

Pooling together data from ABSORB-IV and those of the COMPARE-ABSORB, showed that the scaffold was still associated with a statistically significant increased risk of target-vessel MI (OR 1.5; 95% CI 1.04-2.17; P = 0.03) and thrombotic events (OR 2.85; 95% CI 1.33-6.11; P = 0.007) at 1-year.

Large and recent studies included.

De Rosa R, Silverio A, Varricchio A et al. (2018) Meta-analysis comparing outcomes after everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with acute coronary syndromes. The American Journal of Cardiology. 122: 61-68.

Meta-analysis 6 studies

n= 2,318 patients

Median follow-up was 9.5 (6 to 19.5) months.

Recent meta-analysis on 2,318 patients aimed to assess the safety and efficacy of BVS versus EES in ACS patients having PCI. There was a higher risk of definite stent thrombosis in patients treated with BVS compared to EES (2.3% versus 1.08%, P = 0.03) and an increased risk of TLR at mid-term (9.5 months) follow-up.

More recent studies included.

Diletti R, Farroq V, Girasis C et al. (2013) Clinical and intravascular outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial. Heart 99: 98-105.

Case series

N = 101

Follow-up: 2 years

Angiographic and clinical outcomes in small vessels similar to those in large vessels.

Post-hoc analysis – no new clinical outcomes reported.

Diletti R, Onuma Y, Farooq V et al. (2011) 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5mm. Journal of the American College of Cardiology 58 (3): 258-264.

Case series

N=101

Follow-up: 6 months

Angiographic and clinical outcomes in small vessels similar to those in large vessel.

Post-hoc analysis – no new clinical outcomes reported.

Diletti R, Karanasos A, Muramatsu T et al (2014) Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first

study. Eur Heart J. 35(12):777-86.

Case series

n=49

Patients with STEMI.

everolimus-eluting BVS

Follow-up: 30 days

Procedural success was 97.9%. A TIMI-flow III was achieved in 91.7% of patients, diameter stenosis was 14.7% and no visible residual thrombus. OCT in 31 patients showed that the mean lumen area was 8.02 mm, mean incomplete scaffold apposition area 0.118 mm, mean intraluminal defect area 0.013 mm, and mean percentage malapposed struts per patient 2.80%. Scaffolds with >5% malapposed struts were 7. At 30-days follow-up, target-LFR was 0%. Non-TVR and target-vessel MI were reported. A non-target-vessel non-Q-wave MI occurred. No cases of cardiac death or ScT were seen.

Studies with longer follow included in table 2.

Dudek D, Onuma Y, Ormiston JA et al. (2012) Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention 7: 1060-1061.

Case series (ABSORB cohort A) 30 patients with a single de novo native coronary artery lesion.

At 4 years, the hierarchical ID-MACE of 3.4% remained unchanged without any late complications such as stent thrombosis. Clopidogrel therapy had been stopped in all patients.

Large and more recent studies included.

Elias J, van Dongen IM, Kraak RP

et al. (2017) Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus eluting stents in coronary artery disease: a weighted meta-analysis of seven randomised controlled trials including 5577 patients. Netherlands Heart Journal. 25: 429-438.

Meta-analysis

n=3258 patients treated with BVS and 2319 with EES.

The BVS group had higher rates of TLF (OR 1.34; P = 0.003), definite/probable DT (OR 2.86; P < 0.001) extending beyond 1 year of follow-up (OR 4.13; P < 0.001), clinically indicated or ischemia driven TLR, and all-cause MI. There was no significant difference with respect to cardiac death.

More recent studies included.

Elias J, van Dongen IM, Kraak RP

et al. (2017) Mid-term clinical outcomes with everolimus eluting bioresorbable scaffolds versus everolimus-eluting metallic stents for percutaneous coronary interventions: a meta-analysis of randomized trials. EuroIntervention. 25: 429-438.

Meta analysis in 5583 patients. 7 trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1-3 years.

BVS displayed a higher risk of TLF (OR= 1.35; P = 0.0028) and stent thrombosis (OR 3.24; P < 0.0001) compared to EES particularly after 1 year from implantation. At mid-term follow-up, BVS had a higher risk of TLR and stent thrombosis than the second-generation DES in patients with ACS. Stent thrombosis was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.

Large and recent studies included.

Ellis SG, Kereiakes DJ, Metzger DC, et al. (2015) Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med; 373: 1905-15.

RCT Absorb III

N=2008 patients with stable or unstable angina (Absorb scaffold 1322 versus DES Xience 686 patients)

In this large-scale, randomised trial, treatment of noncomplex obstructive CAD with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year.

Large and recent studies included.

Erbel R, Di Mario C, Bartunek J et al. (2007) Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet 369 (9576): 1869-1875

Case series

N=63 (71 stents)

Follow-up 12 months.

Diameter stenosis was reduced from 61·5% to 12·6% with an acute gain of 1·41 mm and in-stent late loss of 1·08 mm. The ischaemia-driven TLR rate was 23·8% after 4 months, and the overall TLR rate was 45% after 1 year. No MI, subacute or late thrombosis, or death occurred.

Large and more recent studies included.

Fam JM, Ojeda S, Garbo R et al. (2017) Everolimus-eluting bioresorbable vascular scaffolds for treatment of complex chronic total occlusions. EuroIntervention; 13:355-363.

Registry

N=105 patients with complex chronic total occlusions who had Absorb BVS

6 months follow-up.

Device success and procedural success rates were 98.1% and 97.1%, respectively. At 6-month follow-up, a total of 3 events were reported: 1 periprocedural MI, 1 late ScT and 1 additional TLR.

Larger studies included.

Farag M, Spinthakis N, Gorog DA, et al. (2016) Use of bioresorbable vascular scaffold: a meta-analysis of patients with coronary artery disease. Open Heart; 3: e000462.

Meta-analysis comparing outcomes between BVS and DES in patients with CAD

6 randomised trials (3818 patients) and 6 registry studies (1845 patients)

In 6 randomised trials (3818 patients), BVS increased the risk of subacute stent thrombosis (ST) over and above DES (OR 2.14; CI 1.01 to 4.53; p=0.05), with a trend towards an increase in the risk of MI (125 events in those assigned to BVS and 50 to DES; OR 1.36; CI 0.97 to 1.91; p=0.07). The risk of in-device late lumen loss (LLL) was higher with BVS than DES (mean difference 0.08 mm; CI 0.03 to 0.13; p=0.004). There was no difference in the risk of death or TVR between the 2 devices. In 6 registry studies (1845 patients), there was no difference in the risk of death, MI, TVR or subacute ST between the 2 stents. Final BVS dilation pressures were higher in registry than in randomised studies (18.7±4.6 vs 15.2±3.3 atm; p<0.001).

More recent studies included.

Felix CM, Vlachojannis GJ, Ij AJJ et al. (2017) Potentially increased incidence of scaffold thrombosis in patients treated with Absorb BVS who terminated DAPT before 18 months. EuroIntervention;13: e177–e184.

Registries of 3 centres were pooled (808 patients)

18 months.

Data pooled from 3 registries suggested that in patients event-free at 6 months, the incidence of ScT was low while on DAPT but higher when DAPT was terminated before 18 months.

Large and recent studies included.

Felix CM, Fam JM, Diletti R, et al. (2016) Mid- to long-term clinical outcomes of patients treated with

the everolimus-eluting bioresorbable vascular scaffold: the BVS Expand Registry. JACC: Cardiovasc Intervent; 9(16):1652–63.

Prospective case series

N=249 patients with 335 lesions

Absorb BVS

Median follow-up period was 622 (interquartile range: 376 to 734) days.

The MACE rate at 18 months was 6.8%. Rates of cardiac mortality, MI, and TLR at 18 months were 1.8%, 5.2%, and 4.0%, respectively. Definite ScT rate was 1.9%. In our study, BVS implantation in a complex patient and lesion subset was associated with an acceptable rate of adverse events in the longer term, whereas no cases of early thrombosis were seen.

Larger studies included.

Gomez-Lara J, Ortega-Paz L, Brugaletta S et al. (2020) Bioresorbable scaffolds versus permanent sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction: vascular healing outcomes from the MAGSTEMI trial. EuroIntervention. 16(11):e913-e921.

N=95 patients from the randomised MAGSTEMI trial MgBRS =48, and sirolimus-eluting stents (SES=47) had OCT imaging at 1 year.

Both MgBRS and SES exhibited a low degree of neointima healing, but lumen dimensions were smaller with MgBRS at 1 year. Although the advanced bioresorption state of MgBRS hampers the assessment of scaffold collapse, this seems to be the main mechanism of restenosis. Future generations of MgBRS should increase and prolong the radial force.

Related publications included.

Gao R, Yang Y, Han Y, et al. (2015) Bioresorbable vascular scaffolds versus metallic stents in patients

with coronary artery disease: ABSORB China trial. J Am Coll Cardiol; 66(21):2298–309.

RCT (NCT01923740)

N=480 patients

241 BVS versus 239 DES CoCr EES

Follow-up 1 year

Acute clinical device success (98.0% versus 99.6%; p = 0.22) and procedural success (97.0% and 98.3%; p = 0.37) were comparable in BVS- and CoCr-EES-treated patients, respectively. The primary endpoint of in-segment LL at 1 year was 0.19 ± 0.38 mm for BVS versus 0.13 ± 0.38 mm for CoCr-EES; the 1-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of BVS compared with CoCr-EES (noninferiority = 0.01). BVS and CoCr-EES also had similar 1-year rates of TLF (cardiac death, target vessel MI, or ischemia-driven TLR; 3.4% versus 4.2%, respectively; p = 0.62) and definite/probable scaffold/stent thrombosis (0.4% versus 0.0%, respectively; p = 1.00).

Study included in systematic reviews and HTA

García-García HM, Gonzalo N, Pawar R et al. (2008) Assessment of the absorption process following bioabsorbable everolimus-eluting stent implantation: temporal changes in strain values and tissue composition using intravascular ultrasound radiofrequency data analysis. A substudy of the ABSORB clinical trial. EuroIntervention 4: 443-448

Case series

N = 27 IVUS radiofrequency data analysis, RF (13 IVUS virtual histology and 12 palpography)

Follow-up: 6 months

Authors conclude that there were changes in the BVS with a reduction of radiofrequency backscattering by polymeric struts. An increase in endoluminal deformability of the vessel was also suggested at 6 months.

Sub-study. Focus on imaging outcomes.

Gheorghe L, Millan X, Jimenez- Kockar M et al. (2019) Bioresorbable vascular scaffolds in coronary chronic total occlusions: clinical, vasomotor and optical coherence tomography findings at three year follow-up (ABSORB -CTO study). EuroIntervention 15, 99-107.

Case series

ABSORB CTON=33 patients (35 CTO lesions)

Follow-up 3 years

Late acquired incomplete scaffold apposition (LAISA) seen at 12 months in 3 patients was completely undetectable at 3 years. Successful recanalisation of coronary CTO with BVS implantation is associated with favourable clinical and imaging outcomes. Despite vessel motility restoration, successfully treated CTOs remain with signs of endothelial dysfunction.

Larger studies included.

Goel S, Pasam RT, Chava S et al. (2020) Three to four years outcomes of the absorb bioresorbable vascular scaffold versus second-generation drug-eluting stent: A meta-analysis. Catheter Cardiovasc Interv; 95:216–223.

Meta-analysis

N=4 RCTs (n = 3,245, BVS = 2075, DES = 1,170)

Follow-up 4 years

Pooled analysis revealed that there was no difference between

absorb BVS and second-generation DES with respect to TLF

(OR = 1.23, 95% CI = 0.73–2.07, p = 0.44), TV-MI (OR = 1.03, 95% CI = 0.42–2.53, p = 0.95), TLR (OR = 1.61, 95% CI = 0.77–3.33,

p = 0.20) and definite/probable DT (OR = 0.71, 95% CI = 0.10–5.07, p = 0.74). Also, there was no difference in cardiac mortality (OR = 0.66, 95% CI = 0.22–1.94, p = 0.45).

Larger studies included.

Gogas BD, Serruys PW, Diletti R et al. (2012) Vascular response of the segments adjacent to the proximal and distal edges of the ABSORB everolimus-eluting bioresorbable vascular scaffold: 6-month and 1-year follow-up assessment. JACC: Cardiovascular Interventions 5 (6): 656-665.

Case series

N= 101

Follow-up: 1 year

Authors conclude that similar to metallic DES, there was some proximal edge constrictive remodelling and distal edge increase in fibrofatty tissue.

Sub-study. Focus on imaging outcomes.

Gogas BD, Bourantas CV, Garcia-Garcia HM et al (2013).

The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: Insights from the first-in-man ABSORB Cohort B and SPIRIT II trials.

EuroIntervention.9 (6) (pp 709-720).

Comparative study

ABSORB (BVS) Cohort B1 (n=45) and the SPIRIT II (EES) (n=113)

22 proximal and 24 distal edge segments were available for analysis in the ABSORB Cohort B1 trial. In the SPIRIT II trial, 33 proximal and 46 distal edge segments were analysed. At the 5-mm proximal edge, the vessels treated with an Absorb BVS from post procedure to 2 years demonstrated a lumen loss (LL) of 6.68% (-17.33; 2.08) (p=0.027) with a trend toward plaque area increase of 7.55% (- 4.68; 27.11) (p=0.06). At the 5-mm distal edge no major changes were evident at either time point. At the 5-mm proximal edge the vessels treated with a XIENCE V EES from post procedure to 2 years did not show any signs of LL, only plaque area decrease of 6.90% (-17.86; 4.23) (p=0.035). At the distal edge no major changes were evident with regard to either lumen area or vessel remodelling at the same time point.

Study reports mainly, IVUS outcomes.

Gori T, Weissner M, Gonner S et al. (2017) Characteristics, Predictors, and Mechanisms of Thrombosis in Coronary Bioresorbable Scaffolds: Differences Between Early and Late Events. JACC Cardiovasc Interv; 10:2363−71

Registry analysis

N=657 patients who had 925 coronary bioresorbable scaffolds (BRS)

3-year follow-up.

28 stent thrombosis recorded: 14 early (2.2%), 5 late (0.9%), and 9 very late (1.7%).The incidence of both early and late or very late stent thrombosis were lower (∼80% reduction) when an optimal implantation technique was used. The most important factor appeared to be vessel and BRS sizing.

Large and recent studies included.

Ghimire G, Spiro J, Kharbanda R et al. (2008) Initial evidence for the return of coronary vasoreactivity following the absorption of bioabsorbable magnesium alloy coronary stents. EuroIntervention 4: 481-484.

N = 5 absorbable metallic stents versus 10 permanent metal stents

Follow-up: 4 months

Authors conclude that vasomotor function in reference segments is similar for absorbable metallic stents and permanent metal stents although there is also vasodilatation in those with absorbable metallic stents.

Sub-study. Focus on imaging outcomes.

Gomez-Lara J, Brugaletta S, Farooq V et al. (2011) Angiographic geometric changes of the lumen arterial wall after bioresorbable vascular scaffolds and metallic platform stents. JACC: Cardiovascular interventions 4 (7): 789-799.

N: 86 (BVS) versus 75 (metallic platform stent)

Follow-up: 12 months.

Authors conclude that coronary geometry findings of BVS were similar to that of the metallic platform stent.

Comparative sub-study. Focus on imaging outcomes,

Gomez-Lara J, Brugaletta S, Farooq V et al. (2011). Head-to head comparison of the neointimal response between metallic and bioresorbable everolimus-eluting scaffolds using optical coherence tomography. JACC: Cardiovascular Interventions 4 (12): 1271-1280.

N: 30 (BVS) versus 14 (DES)

Follow-up: 1 year

Authors conclude that similar neointimal responses were seen in the tw2o types of stent although intraluminal masses in a small proportion of patients with a BVS were also seen.

Comparative sub-study. Focus on imaging outcomes.

Gomez-Lara J, Diletti R, Brugaletta S, Onuma Y et al. (2011) Angiographic maximal luminal diameter and appropriate deployment of the everolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography: an ABSORB cohort B trial sub-study. Eurointervention 8: 214-224.

N = 53

Follow-up: post-procedure.

Authors conclude that lesions of diameter 2.5-3.3mm achieved better deployment than those of other sizes

Sub-study. Focus on imaging outcomes.

Guitérrez-Chico JL, Radu MD, Diletti R et al. (2012) Spatial distribution and temporal evolution of scattering centers by optical coherence tomography in the poly (L-lactide) backbone of a bioabsorbable vascular scaffold. Circulation Journal 76: 342-350.

N=3

Follow-up: 6 months.

Scattering centres seen on OCT imaging of the BVS were only located at inflection points and did not increase between baseline and 6 months follow-up.

Sub-study. Focus on imaging outcomes.

Guitiérrez-Chico JL, Serruys PW, Girasis C et al. (2012) Quantitative multi-modality imaging analysis of a fully bioresorbable stent: a head-to-head comparison between QCA, IVUS and OCT. International Journal of Cardiovascular Imaging 28: 467-478.

N = 45 (quantitative coronary angiography), 40 (IVUS), 29 OCT, 26 (all imaging)

Follow-up: 6 months

Authors conclude that OCT was the most accurate method to measure BVS length and there was poor agreement between difference imaging modalities with respect to minimal lumen diameter measurements.

Sub-study. Focus on imaging outcomes.

Grundeken MJ, White RM, Hernandez JB, et al. The incidence and relevance of site-reported

versus patient-reported angina: insights from the ABSORB II randomized trial comparing Absorb

everolimus-eluting bioresorbable scaffold with XIENCE everolimus-eluting metallic stent.

Eur Heart J Qual Care Clin Outcomes 2016;2(2):108–16.

RCT Absorb BVS II

501

(335 versus

166) Everolimus-eluting BRS/Absorb® versus

everolimus-eluting permanent metallic

stent/Xience®

Follow-up 4 years.

We showed that the site-reported angina through AE reporting may be clinically relevant because of their relation with cardiovascular events (mostly repeat revascularisations), cardiovascular resource utilisation, ETT, and SAQ.

Large and longer follow-up studies included.

Haude M, Erbel R, Erne P et al. (2013) Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de novo coronary lesions: 12 month results of the prospective, multi-centre, first-in-man BIOSOLVE-I trial. Lancet 381: 836-844.

Case series

n=46 (47 lesions)

DREAMS scaffold Magmaris

symptomatic patients with de-novo coronary lesions.

12 months follow-up.

Device and procedural success was 100%. 2/46 (4%) patients had TLF at 6 months, and 3/43 (7%) at 12 months.1 periprocedural target vessel MI occurred during angiography at 12 month, no cardiac death or ScT. Mean late lumen loss with the Magmaris DES was somewhat higher than is seen with metallic DES and remained stable between 6 and 12 months: in-segment late lumen loss 0.20 mm and 0.25, p = 0.117, delta late loss 0.05 mm (95% CI: 20.01; 0.12); in-scaffold late lumen loss 0.37 mm versus 0.39 mm, p = 0.446, delta late loss 0.03 (95% CI: 20.04–0.10), respectively.

Larger and more recent studies included.

Haude M, Ince H, Abizaid A, et al. (2016) Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the

BIOSOLVE-II first-in-man trial. Eur Heart J; 37:2701–2709.

Case series

n= 123 patients with

Magmaris drug-eluting stents

(BIOSOLVE-II study)

12 months.

Overall rates of clinical

events at 12 months were low: TLF was seen in 3.4%, 95% CI: 0.9–8.4. mean late lumen loss at follow-up with the DES Magmaris was somewhat higher than is seen with conventional metallic DES and remained stable between 6 and

12 months: in-segment late lumen loss 0.20 mm and 0.25 mm, P = 0.117, delta late loss 0.05 mm (95% CI: 20.01; 0.12); in-scaffold late lumen loss 0.37 mm vs 0.39 mm, p = 0.446, delta late loss 0.03 (95% CI: 20.04 to 0.10), respectively.

Larger and more recent studies included.

Haude M, Ince H, Abizaid A et al. (2016) Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet; 387:31–39.

Case series

n= 123 patients coronary target lesions.

Magmaris drug-eluting

results from the BIOSOLVE-II study

6 months follow-up.

At 6 months, mean in-segment late lumen loss was 0·27 mm, and vasomotion was documented in 80% 20/25 patients. IVUS assessments showed a preservation of the scaffold area (mean 6·24 mm² post-procedure vs 6·21 mm² at 6 months) with a low mean neointimal area (0·08 mm² [0·09]), and OCT did not detect any intraluminal mass. TLF occurred in 4 (3%) patients: 1(<1%) patient died from cardiac death, 1 (<1%) patient had periprocedural MI, and 2 (2%) patients needed clinically driven TLR. No definite or probable ScT was seen.

Larger studies included.

Hellenkamp K, Becker A, Gabriel YD et al. (2017) Mid- to long-term outcome of patients treated

with everolimus-eluting bioresorbable vascular scaffolds: data of

the BVS registry Göttingen predominantly from ACS patients. International Journal of Cardiology. 234: 58-63.

BVS registry Göttingen

N=195 patients

44 BVS were implanted.

Although, the rates of (potentially) device-related complications following BVS implantation are acceptable, they are nonetheless not negligible. Interestingly, they did not decline over time. Bifurcation stenting could be found as relevant procedure-related predictor of DOCE, especially in ACS patients.

Large and recent studies included.

Hommels TM, Hermanides RS, Berta B et al. (2020)

Everolimus-eluting bioresorbable scaffolds and metallic stents in diabetic patients: a patient-level pooled analysis of the prospective ABSORB DM Benelux Study, TWENTE and DUTCH PEERS

Cardiovasc Diabetol 19:165.

N=499 diabetic patients who were treated with EE-BRS or EES in 3 prospective clinical trials:

150 had EE-BRS and 249 had EES

Follow-up was 222.6 patient years (PY) in the EE-BRS and 464.9 PY in the EES group.

The adverse events rates were similar in both treatment groups for TLF (7.2 versus 5.2 events per 100 PY, p=0.39; adjusted HR=1.48 (95% CI: 0.77–2.87, p=0.24), MACE (9.1 versus 8.3 per 100 PY, p=0.83; adjusted HR=1.23 (95% CI: 0.70–2.17, p=0.47), and ST (0.9 versus 0.6 per 100 PY, p>0.99). In this patient-level pooled analysis of patients with diabetes mellitus from 3 clinical trials, EE-BRS showed clinical outcomes that were quite similar to EES.

Larger studies included.

Hoppmann P, Kufner S, Cassese S et al. (2016) Angiographic and clinical outcomes of patients treated with everolimus-eluting bioresorbable stents in routine clinical practice: results of the ISAR-ABSORB registry. Catheter Cardiovasc Interv; 87:822–829.

Case series

N=419 patients implanted everolimus-eluting BRS.

12 months follow-up.

At angiographic follow-up in-stent late loss was 0.26 ± 0.51 mm, in-segment diameter stenosis was 27.5 ± 16.1, and binary angiographic restenosis was 7.5%. At 12 months, the rate of death, MI, or TLR was 13.1%. Definite stent thrombosis occurred in 2.6%.

Large and recent studies included.

Ishibashi Y, Muramatsu T, Nakatani S, et al. Incidence and potential mechanism(s) of

post-procedural rise of cardiac biomarker in patients with coronary artery narrowing after

implantation of an everolimus-eluting bioresorbable vascular scaffold or everolimus-eluting

metallic stent. JACC: Cardiovasc Intervent 2015;8(8):1053–63.

RCT Absorb BVS II

501

(335 versus

166) Everolimus-eluting BRS/Absorb® versus

everolimus-eluting permanent metallic

stent/Xience®

Follow-up 4 years.

Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% versus Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% versus EES: 19.9%, p = 0.39).There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury.

Large and recent studies included.

Ishibashi Y, Nakatani S, Sotomi Y et al. (2015) Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv; 8:1715−26.

1,248 patients had Absorb scaffolds in the ABSORB Cohort B study (N = 101), ABSORB EXTEND study (N = 812), and ABSORB II trial (N = 335).

The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold non-oversize group (MACE 6.6% versus 3.3%; log-rank p < 0.01, all MI: 4.6% versus 2.4%; log-rank p = 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% versus 1.9%; p = 0.08). Implantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI.

Large and recent studies included.

Ishibashi Y, Onuma Y, Muramatsu T, et al on behalf of the ABSORB EXTEND Investigators (2014). Lessons learned from acute and late scaffold failures in the ABSORB EXTEND trial. EuroIntervention 9-online publish-ahead-of-print January 2014.

Case series (Absorb extend)

N=450

Follow-up 12 months

low rates of ischaemia-driven MACE (4.2%) and TVF (4.7%) at 12 months. 7 cases of device failure: 3 scaffold dislodgement (0.67%) and 4 subacute or late ScT (0.89%). In 2 dislodgement was seen after reinsertion. 2 subacute ScT and 2 late scaffold thromboses were seen and related to either premature stopping of dual antiplatelet therapy (DAPT) or resistance to clopidogrel.

Large studies included.

Ielasi A, Cortese B, Moscarella E et al. (2018) One-year clinical outcomes after unrestricted implantation of the Absorb bioresorbable scaffold (RAI registry). EuroIntervention. 14: e546-e553.

RAI registry

N=1505

Patients with pre-dilatation and post-dilatation.

1 year follow-up

At 1-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% versus 2.2%; P = 0.05) while a trend towards a higher ScT rate was seen in the off-label group (1.7% versus 0.6%; P = 0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR.

Large and recent studies included.

Ielasi A, Cortese B, Varricchio A, et al. Immediate and midterm outcomes following primary

PCI with bioresorbable vascular scaffold implantation in patients with ST-segment myocardial

infarction: insights from the multicentre "Registro ABSORB Italiano" (RAI registry).

Eurointervention 2015;11(2):157–62.

Prospective cohort analysis 

N= 72 STEMI patients who had primary PCI with BVS implantation.

6 month follow-up.

BVS implantation in STEMI patients can be successfully performed with a high procedural success rate and encouraging midterm outcomes. Larger randomised trials and longer follow-up are needed to assess the potential clinical benefit of BVS versus new-generation DES in this setting.

Large studies included.

Ielasi A, Varricchio A, Campo G, et al. (2017) A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study. Catheter Cardiovasc Interv. 2017; 89(7):1129-1138.

Prospective registry n= 500 STEMI patients having primary PCI with BVS (1.1 or GT1)

The first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study.

Only design of the study.

Ielasi A, Campo G, Cortese B et al. (2019) One-Year Results Following a Pre-Specified ABSORB Implantation Strategy in ST-Elevation Myocardial Infarction (BVS STEMI STRATEGY-IT Study). Cardiovasc Revasc Med. 2019 Aug;20(8):700-704.

N=505 STEMI patients having PCI with Absorb.

Follow-up 1 year.

A pre-specified Absorb implantation strategy in STEMI patients was associated with persistent low DOCE and ScT rates at 1-year. Longer term follow-up is needed to assess the role of this strategy on preventing very-late events (NCT02601781)

Large studies included.

Jabbour RJ, Tanaka A, Capranzano P et al. (2017) Bioresorbable vascular

scaffolds as a treatment

option for left main lesions. JACC: CARDIOVASCULAR INTERVENTIONS VOL. 10 (7)

Retrospective analysis

International registry

N=60 patients (2,765 PCI) Absorb BVS

median follow-up time was 593 days (interquartile

range: 230 to 817 days)

The primary endpoint of TLF occurred in 14.9% (n =7) and 25.0% (n=10) of patients at 1 and 2 years, respectively. This was primarily caused by ischemia-driven TLR because the overall TLR rate was 13.4% (n= 6) and 23.6% (n = 9) at 1 and 2 years. The cardiac death rate was 1.8% (n =1) at 2 years and there were no target vessel MI or definite/probable ST segment events at 2 years.

Larger studies included.

Jaguszewski M, Ghadri JR, Zipponi M et al. (2015) Feasibility of second-generation bioresorbable vascular scaffold

implantation in complex anatomical and clinical scenarios. Clin Res Cardiol; 104:124–135

N=106 patients had in total 193 BVS implantations. Mean follow-up of 147 ± 119 days

Rate of device-related events was 2.0 %, whereas patient-related composite events occurred in 6.1 %. Our results strongly suggest that BVS implantation is feasible in a wide spectrum of patients and complex anatomy of coronary lesions.

Large and recent studies included.

Katagiri Y, Onuma Y, Asano T et al. (2018) Three year follow-up of the randomised comparison between

an everolimus-eluting bioresorbable scaffold and a durable polymer everolimus-eluting metallic stent in patients with

ST-segment elevation myocardial infarction (TROFI II trial). EuroIntervention;14:

e1224-e1226.

N=191 patients withSTEMI had either the Absorb BRS (n=95) or the XIENCE metallic everolimus-eluting stent (n=96).

Follow-up 3 years

At 3 years, the rates of DOCE were 5.3% (5/95) in the BRS arm and 3.1% (3/96) in the EES arm without a statistically significant difference (p=0.465). There were 2 cardiac deaths (2.1%) in the BRS arm: 1 was a cardiac death on day 280, the second patient died on day 999 revealed no evidence of ScT. There were no cardiac deaths in the EES arm.

Larger studies included.

Kajiya T, Liang M, Sharma RK et al. (2013) Everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). EuroIntervention 9-online publish-ahead-of-print May 2013.

Case series

N=11

Median 53 days

One patient presented to the hospital with cardiogenic shock and subsequently died. The other 10 patients did not have any MACE. There were no acute or subacute stent thromboses at short-term follow-up.

Large and more recent studies included.

Keh YS, Yap J, Yeo KK et al (2016) Clinical Outcomes of Bioresorbable Scaffold in Coronary Artery Disease:

A Systematic Literature Review. Journal of Interventional Cardiology, 29 (1), 57-69.

Systematic Review

31 studies included.

The studies were categorised into: STEMI, stable CAD, and "all-comers" group. 31 studies were included; 8 in STEMI patients (all ABSORB), 15 stable CAD patients. In the STEMI group (n=606), acute procedural success ranged from 96% to 100%, cardiac mortality 0–9.1%, recurrent MI and stent thrombosis rates were 0–4.3%. In the stable CAD group, the 13 ABSORB studies (n=3259) demonstrated cardiac mortality rate of 0–0.6%, recurrent MI rate 0–4.5%, and stent thrombosis rate 0–4.3%

More recent reviews included.

Kereiakes DJ, Ellis SG, Metzger C et al. (2017) ABSORB III Investigators. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. J Am Coll Cardiol. 12; 70 (23): 2852-2862.

RCT

ABSORB III

N=2,008 patients with CAD randomised to BVS versus cobalt-chromium everolimus-eluting stents (EES).

The target LFR at 3 years was 13.4% for BVS compared with 10.4% in the everolimus-eluting stent group (p = 0.06). Target vessel MI (8.6 versus 5.9% respectively, p = 0.03) and ScT (2.3 versus 0.7% respectively, p = 0.01) were also significantly higher in the BVS arm. 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis.

Larger and more recent studies added.

Kereiakes DJ, Ellis SG, Metzger C, et al. (2019) Clinical outcomes before and after complete

everolimus-eluting bioresorbable scaffold

resorption. Five-year follow-up from the ABSORB III Trial. Circulation;140:1895–1903.

ABSORB III RCT 1322 BVS compared with 686 cobalt chromium everolimus-eluting stents.

Follow-up 5 years

In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. Between the 3- and 5-year follow-up, substantial reductions in BVS-relative hazards for TLF and ScT were seen, coincident with complete BVS resorption.

Large and more recent studies added.

Kocka V, Maly M, Tousek P et al. (2014) Bioresorbable vascular scaffolds in acute ST-segment elevation myocardial infarction: a prospective multicentre study 'Prague 19'. European Heart Journal. 35, 787–794.

Prospective study

N=41 BVS implantation during PCI in STEMI

The BVS device success was 98%, thrombolysis in MI 3 flow was restored in 95% of patients, and acute scaffold recoil was 9.7%. Event-free survival was the same in both groups; 95% for BVS and 93% for control group, P =0.674.

Large and more recent studies added.

Kočka V, Toušek P, Kozel M et al. Bioresorbable scaffold implantation in STEMI patients: 5 years imaging sub-analysis of PRAGUE-19 study. J Transl Med; 18(1):33

Case series

N=83 STEMI patients with BRS

5 year follow-up was done in 25 patients.

Invasive imaging results 5 years after BRS implantation in STEMI showed complete resorption of scaffold struts and stable lumen vessel diameter. 3 patients developed small coronary artery aneurysm in the treated segment.

Large studies included.

Kozuma K, Tanabe K, Hamazaki Y et al. (2020) Long-term outcomes of absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent― A randomized comparison through 5 years in Japan. Circulation Journal Circ J; 84: 733–741

ABSORB Japan RCT

randomised 400 patients into either Absorb (n=266) or XIENCE (n=134)

follow-up 5 years

There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years. Numerically lower TVF, MACE, and all MI rates were seen for the Absorb versus XIENCE arm after 3 years. No scaffold/stent thrombosis was reported beyond 3 years. Post-procedure imaging subgroups showed comparable event rates.

Included in systematic reviews.

Liang M, Kajiya T, Lee CH et al (2013). Initial experience in the clinical use of everolimus-eluting bioresorbable vascular scaffold (BVS) in a single institution.

International Journal of Cardiology.168 (2) (pp 1536-1537).

Case series

n=35 [41 lesions] Patients with an ACS including stable angina, unstable angina, non-STEMI, STEMI had ABSORB BVS implanted. 60 days follow-up.

45 BVS were successfully implanted in 93.3% (33/35) patients. In 41 implantations, the success rate was 100% for LAD (22/22), 100% for RCA (11/11) AND 75% (6/8) FOR LCX.

2 patients with circumflex stenosis (unsuccessful implantations) were treated with DES. There were no procedure related acute or subacute stent thrombosis, in hospital or adverse events.

Larger studies with longer follow included in table 2.

La, Manna A, Ohno Y, Attizzani, GF et al (2013). Successful retrograde recanalization of chronic total coronary occlusion with multiple bioresorbable vascular scaffolds ('full polymer jacket'): Initial experience and rationale. European Heart Journal.34 (37) (pp 2925).

Case report

Multiple (4) BRS used in a patient with very long chronic total occlusion. Excellent angiographic and OCT results obtained.

Study reports mainly angiographic, IVUS and OCT outcomes.

Lesiak M, Lanocha M, Araszkiewicz A et al. (2016) Percutaneous coronary intervention for chronic total

occlusion of the coronary artery with the implantation of

bioresorbable everolimus-eluting scaffolds.

Poznan CTO-Absorb Pilot Registry. EuroIntervention;12: e144- e151.

Case series

(registry)

N= 40 patients with CTO treated with BVS.

Follow up (median 556 days)

Procedural success was achieved in all patients with no device-related complications. There were no deaths, 1 patient experienced subacute and late ScT, and another 1 developed symptomatic in-scaffold focal restenosis treated with repeat PCI. No more restenosis or vessel reocclusion was found.

Larger studies included.

Lipinski MJ, Escarcega RO, Baker NC, et al. (2016) Scaffold Thrombosis After Percutaneous Coronary Intervention With ABSORB Bioresorbable Vascular Scaffold: A Systematic Review and Meta-Analysis. JACC Cardiovasc Interv; 9:12-24.

Systematic Review and Meta-Analysis.

N=10510 patients treated with BVS where post-dilatation was performed in 52% of lesions.

Compared to DES, there were higher rates of MI (OR 2.06, p =0.002) and definite or probable ScT (OR 2.06, P = 0.03) in the BVS group [24]. No significant difference was found for all-cause and cardiovascular mortality.

More recent studies included.

Mahmoud AN, Barakat AF, Elgendy AY et al. (2017) Long-term efficacy and safety of everolimus-eluting

bioresorbable vascular scaffolds versus everolimus-eluting metallic stents

A meta-analysis of randomized trials. Circ Cardiovasc Interv 10:e005286

meta-analysis of RCTs

n= 6 trials with 5392 patients were included (mean follow-up, 25 months).

Compared with everolimus-eluting stents, BVS is associated with increased risk of TLF driven by the increased rates of target vessel MI and ischemia-driven TLR in these studies (mean follow-up, 25 months). The risk of definite or probable stent/ScT and very late stent/ScT seems to be higher with BVS.

More comprehensive studies included.

Moriyama N, Shishido K, Tobita K et al. (2017) Persistent bioresorbable vascular scaffold

by optical coherence tomography

imaging at 5 years. JACC: CARDIOVASCULAR INTERVENTIONS; 10 (2), e11-13.

Case report

N=1 with Absorb BVS

the first case of incomplete absorption for BVS at 5 years. OCT confirmed nearly complete scaffold resorption in the proximal segments, but "black box" objectives remained visible at the distal end of BVS.

Larger studies included.

Muramatsu T, Onuma Y, García-García HM et al. (2013) Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold. An interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT First and II trials. JACC: Cardiovascular Interventions 6 (3): 247-257.

Post-hoc analysis of 3 case series: ABSORB EXTEND (with SPIRIT First and II trial as historical controls)

n=719 (469 ABSORB BVS vs 250 XIENCE V DES)

follow-up 30 days.

Post-procedural side branch occlusion (SBO) was seen in 73 side branches (6.0%) in BVS group and 28 side branches (4.1%) in EES group (p = 0.09). Patients with post-procedural SBO were significantly associated with an increased incidence of in-hospital MI (6.5% in SBO group versus 0.5% in non-SBO group, p < 0.01). Multivariable analysis revealed that BVS was an independent predictor of post-procedural SBO (OR: 2.09; 95% CI: 1.18 to 3.68). 

Large and more recent studies included.

Mukete BN, Van der Heijden LC, Tandjung K et al. (2016) Safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds

versus durable polymer everolimus-eluting metallic stents assessed at

1-year follow-up: A systematic review and meta-analysis of studies. International Journal of Cardiology. 221, 1087-1094.

Systematic review

Of RCTs and propensity scored matched studies

(6 trials with 5588 patients were analysed)

compared BVS and cobalt-chromium durable polymer everolimus-eluting stents (EES).

1 year follow-up.

Device oriented end point was reached by 308 BVS or EES patients (195/3253 versus 113/2315). Meta-analysis showed that patients treated with BVS had a higher incidence of MI and ScT. The risk of DOCE was not significantly different. As BVS may pay off later, future robust data on long-term clinical outcome will be of paramount importance.

Larger and more recent reviews included.

Nairooz R, Saad M, Sardar P et al. (2017) Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis. Heart;103:1096–1103.

Meta-analysis comparing BVS with DES for CAD

N=10 studies (with 2360 patients)

2 years of follow-up

BVS was associated with higher rates of DOCE (6.9% vs 4.5%, OR=1.53; 95% CI 1.06 to 2.23; p=0.02), absolute risk increase (ARI) 2.4%, relative risk increase (RRI) 53%, TV-MI (4% vs 1.8%, OR=1.94; 95% CI 1.02 to 3.67; p=0.04), ARI 2.2%, RRI 122% and definite stent thrombosis (2.1% vs 0.6%, OR=3.39; 95% CI 1.46 to 7.88; p=0.005), ARI 1.5%, RRI 250% compared with DES. No differences in all-cause mortality (OR=0.86; 95% CI 0.26 to 2.81; p=0.80) and TLR (OR=1.44; 95% CI 0.81 to 2.54; p=0.21) were seen between both groups.

Large and recent studies included.

Nieman K, Serruys PW, Onuma Y et al (2013).

Multislice computed tomography angiography for non-invasive assessment of the 18-month performance of a novel radiolucent bioresorbable vascular scaffolding device: the ABSORB trial (a clinical evaluation of the bioabsorbable everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions).

Journal of the American College of Cardiology 62 (19) 1813-1814.

ABSORB Cohort B

n=101

18 months follow-up

At 18 months there were no cardiac deaths and 3 non-Q-wave MIs: 2 during the index procedure, 1 during an intercurrent invasive investigation, and 5 ischemia driven TLRs. The hierarchical major adverse clinical cardiac event rate was 7.9% (n=8).

Study reports mainly angiographic, IVUS and OCT outcomes.

Clinical outcomes from long term follow-up studies included in table 2.

Nooryani AA, Elabbassi WN, AlBaba B et al. (2019) Long-term outcome of first 300 implanted Absorb bioresorbable vascular scaffolds in an all-comers Middle East population. Journal of International Medical Research. 47(1) 173–187.

Prospective registry

n=217 patients with 300 treated lesions treated with Absorb BVS.

median follow-up, 36 months

TVF rate was 32/201 (15.9%), including cardiac death in 10 (5%), target vessel MI in 13 (6.5%), and TLR in 22 patients (10.9%). Definite or probable device thrombosis occurred in 11/201 patients (5.5%). TVF was associated with heart failure, worse ejection fraction, multi-vessel BVS, multi BVS in lesion, and total BVS length >50 mm.

Larger studies included.

Nishio S, Kosuga K, Igaki K et al. (2012) Long-term (>10 years) clinical outcomes of first in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation 125: 2343-2352.

Case series

n=50 patients (63 lesions; 84 stents; 57 procedures)

mean 121 months

There were 1 cardiac death, 6 noncardiac deaths, and 4 Mis. Survival rates free of all-cause death, cardiac death, and MACE at 10 years were 87%, 98%, and 50%, respectively. The cumulative rates of TLR (TVR) were 16% (16%) at 1 year, 18% (22%) at 5 years, and 28% (38%) at 10 years. Two definite scaffold thromboses (1 subacute, 1 very late) were recorded.

Larger and more recent studies included.

Ormiston JA, Serruys PW, Regar E et al.(2008) A bioabsorbable everolimus-eluting coronary stent system for patients with single de novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 371: 899-907.

Case series

N=30

Follow-up: 1 year

Reported in Table 2; shorter follow-up presented in this paper.

Ormiston JA, Serruys PW, Onuma Y et al (2012). First serial assessment at 6 months and 2 years of the second generation of Absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circulation. Cardiovascular Interventions 5: 620-632.

Case series (ABSORB cohort B)

N=45

Follow-up 24 months.

From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on QCA, with an increase in neointima of 0.68±0.43 mm(2) on OCT and 0.17±0.26 mm(2) on IVUS. Struts still recognisable on OCT at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm(2) on IVUS, p=0.003 and 0.77±1.33 m(2) on OCT, p=0.016). 2 year MACE rate was 6.8% without any ScT.

Large and more recent studies included.

Ormiston JA, Webber B, Ubod B et al (2015) An independent bench comparison of two bioresorbable drug-eluting coronary scaffolds (Absorb and DESolve) with a durable metallic drug-eluting stent (ML8/Xpedition). EuroIntervention;11(1):60-7

Absorb and DESolve bioresorbable scaffolds compared with metallic drug-eluting XIENCE Xpedition stent.

Bench testing

The metallic stent has thinner struts, lower profile, and greater radial strength than the polymeric scaffolds. Different safe pressure thresholds exist for different scaffolds/stents. Unlike the others, the DESolve showed "self-correction" or enlargement after initial recoil.

Mechanical and physical properties assessed.

Okamura T, Garg S, Gutiérrez-Chico JL et al. (2010) In vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus-eluting device: an OCT ad hoc analysis of the revision 1.0 and 1.1 stent design in the ABSORB clinical trial. EuroIntervention 5: 932 – 938.

N = 4 (BVS 1.0) versus 4 (BVS 1.1)

Follow-up: Post-procedure only

Authors conclude that imaging confirms the differing strut distribution of the BVS 1.1 from the BVS 1.0.

Comparative sub-study. Focus on imaging outcomes.

Onuma Y, Serruys PW, Gomez J et al. (2011). Comparison of In Vivo Acute Stent Recoil Between the Bioresorbable Everolimus-Eluting coronary Scaffolds (Revision 1.0 and 1.1) and the Metallic Everolimus-Eluting Stent. Catheterization and Cardiovascular Interventions 78: 3-12.

N = 27 (BVS 1.0) versus 88 (BVS 1.1) versus 27 metallic DES

Follow-up: post-procedure.

Authors conclude that acute recoil was slightly higher in the BVS 1.1 and similar to the BVS 1.0 but this was not statistically significant.

Comparative sub-study. Focus on imaging outcomes.

Okamura T, Onuma Y, García-García HM et al. (2010) 3-dimensional optical coherence tomography assessment of jailed side branches by bioresorbable vascular scaffolds. A Proposal for classification. JACC: Cardiovascular Interventions 3 (8): 836-844.

N = 25 (3D assessment)

Follow-up: post-procedure

Authors conclude that reconstruction with 3-dimensional OCT in the evaluation of orifices of side branches jailed with BVS was feasible.

Sub-study. Focus on imaging outcomes.

Otsuka M, Tanimoto S, Sianos G et al. (2009) 'Radio-lucent' and 'radio-opaque' coronary stents characterized by multislice computed tomography. International Journal of Cardiology 132: e8-e10.

Case report

N = 1

Follow-up: 4 days

Authors conclude that there are potential advantages (clear depiction of in-stent lumen) of radio-lucent polymer stents compared with metallic stents with respect to non-invasive multi-slice computed tomography coronary angiography.

Case report of patient included in ABSORB A cohort. Focus on imaging outcomes.

Onuma Y, Dudek D, Thuesen L et al (2013). Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimus-eluting scaffold in patients with de novo coronary artery disease. The ABSORB Cohort A Trial. JACC Cardiovascular Interventions 6 (10): 999-1009.

Case series (ABSORB cohort A) 30 patients with a single de novo coronary artery lesion were treated with Absorb scaffold.

5 years follow-up.

At 46 days, 1 patient had chest pain and had a TLR. At 5 years, the ischemia-driven MACE rate of 3.4% remained unchanged. 4ScT was not seen. 2 noncardiac deaths were reported, 1 caused by duodenal perforation and the other from Hodgkin's disease. At 5 years, 18 patients had MSCT angiography. All scaffolds were patent, with a median minimal lumen area of 3.25 mm2. Non-invasive FFR analysis was feasible in 13 of 18 scans, which yielded a median distal FFR of 0.86.

Large and more recent studies included.

Onuma Y, Collet C, Geuns RJV et al. (2017) Long-term serial non-invasive multislice

computed tomography angiography with

functional evaluation after coronary

implantation of a bioresorbable

everolimus-eluting scaffold: the

ABSORB cohort B MSCT substudy.

European Heart Journal - Cardiovascular Imaging, 18, 870–879.

ABSORB cohort B (101 patients with non-complex de novo lesions)

Follow up 72 months

53 patients hent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 and the mean percentage area stenosis was 18%, 1 scaffold was totally occluded. n 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up. In 39 patients with paired MSCT analysis, the MLA significantly increased from

the first to the second follow-up (p=0.002).

Imaging outcomes.

Onuma Y, Serruys PW, Ormiston JA et al. (2010) Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease; the ABSORB trial. EuroIntervention 6: 447 – 453.

Case series (ABSORB cohort A)

30 patients with a single de novo native coronary artery lesion

3-year clinical results have demonstrated a sustained low MACE rate (3.4%) without any late complication such as stent thrombosis. 2 non-cardiac deaths were reported; 1 from duodenal perforation, the other from Hodgkin disease. 2 patients had non-ischaemia driven TVR.

Large and more recent studies included.

Onuma Y, Chevalier B, Ono M et al. (2020) Bioresorbable scaffolds versus everolimus-eluting metallic stents: five-year clinical outcomes of the randomised ABSORB II trial. EuroIntervention;16: e938- e941.

RCT ABSORB II trial

N=501 patients randomised to Absorb scaffold or XIENCE stent.

Follow-up 5 years in 256 patients (76.4%) and 125 patients (75.3%) in the Absorb arm and the XIENCE arm.

Extended follow up of the randomised ABSORB II trial demonstrates the absence of scaffold/stent thrombosis from 4 to 5 years, and very low additional events beyond 3 years, the time point of full scaffold resorption. The advantage of a bioresorbable scaffold over a metallic stent was not demonstrated.

Large and more recent studies included.

Ortega-Paz L, Capodanno D, Gori T et al. (2017) Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score. EuroIntervention; 12:2110–2117.

GHOST-EU registry

N=1,736 lesions treated with BVS were analysed.

Predilation, correct scaffold sizing, and post-dilation with a non-compliant balloon were performed in 95.7%, 50.2%, and 26.2% of the cases and scored 0.63, 1.96 and 1.93 points, respectively, in the PSP-1 model. PSP-1 was an independent predictor of 1-year device oriented composite endpoint (HR 0.75, 95% CI: 0.61-0.93; p=0.007). No patient with a maximum PSP-1 score had ScT, compared to those with a non-maximum PSP-1 score (0% versus 2.3%; p=0.095). Modification of implantation technique might lead to improved clinical outcomes.

Large and recent studies included.

Ozaki Y, Garcia-Garcia HM, Shlofmitz E et al. (2020) Second-generation drug-eluting resorbable magnesium scaffold: review of the clinical evidence. Cardiovascular Revascularization Medicine; 21: 127-136.

Review BIOSOLVE-II and

BIOSOLVE-III with 184 patients who had DREAMS 2G scaffold (i.e. 2^nd generation; Magmaris®, Biotronik AG)

At 24 months, the TLF, TVMI, and TLR rates were 5.9%, 0.9%, and 3.4% respectively with no definite or probable stent thrombosis. The BIOSOLVE-IV was a single-arm, multicentre registry that included data of 400 patients with a 12-month follow up. RMS showed similar performance to second-generation DES.

Review

Pellicano M, Di Gioia, Ciccarelli G et al. (2020) Procedural microvascular activation in long lesions treated

with bioresorbable vascular scaffolds or everolimus-eluting

stents: the PROACTIVE trial. EuroIntervention; 16: e147- e154.

RCT

N=66 having elective PCI in long lesions were randomised 1:1 to either 33 BVS or 33 EES

In long lesions, BVS implantation is associated with a significant reduction in pressure-derived corrected index of microvascular resistance as compared with EES. The limited acute impact of BVS on the microcirculation effect is associated with an optimal periprocedural and short-term platelet inhibition, without significant difference in periprocedural myonecrosis as compared with patients treated with EES.

Larger studies included.

Polimeni A, Anadol R, Münzel T et al (2017) Long-term outcome of bioresorbable vascular scaffolds for the treatment of coronary artery disease: a meta-analysis of RCTs.

BMC Cardiovascular Disorders. 17: 147.

Meta-analysis

N=5219 patients (BVS versus DES EES).

For BVS with higher rates of TLF (9.4% vs 7.2%; OR = 1.33; P = 0.008) and DT (2.3% vs 0.7%; OR = 3.22; P <0.0001) compared with EES. BVS were associated with worse clinical outcomes at 2-years and higher incidence of both early (within 30 days after implantation) and very-late (> 1 year) DT.

More recent studies included.

Puricel S, Cuculi F, Weissner M et al. (2016) Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol; 67:921−31.

Registry analysis

N=1,305 consecutive patients (mean age 64 years, 78% male) who had 1,870 BVS 

Follow-up 485 days.

Stent thrombosis occurred in 42 patients. The incidence of probable and definite stent thrombosis was 1.8% at 30 days and 3.0% at 12 months this could be significantly. The rate of ScT declined significantly in patients when a strategy optimised for BVS was applied rather than a DES-oriented implantation strategy.

Large and recent studies included.

Reichart C, Wohrle J, Markovic S et al. (2019) Clinical results of bioresorbable drug-eluting scaffolds in short and long coronary artery lesions using the PSP technique. BMC Cardiovascular Disorders, 19:22

Prospective study

N=326 patients with 421 lesions PCI with the Absorb BVS

patients with short (< 20 mm) and long (≥20 mm) coronary artery lesions after implantation of bioresorbable vascular scaffolds (BVS) via PSP-technique.

Follow-up 36 months

Device oriented composite endpoint (DOCE) after 12 months were 2.63% for short lesions and 8.09% for long lesions (p =0.0131), 5.51% versus 11.35% (p = 0.0503) after 24 months and 8.00% versus 18.00% (p = 0.0264) after 36 months of clinical follow-up. Kaplan-Meier estimates for TLR after 12 months were 1.46% for short and 7.69% for long lesions (p = 0.0012),2.06% versus 8.75% after 24 months (p = 0.0027) and 4.96% versus 9.59% after 36 months of follow-up (p = 0.0109). ScT rates were low.

Large and more recent studies included.

Rzeszutko Ł, Siudak Z, Włodarczak A, et al. (2014) Contemporary use of bioresorbable vascular scaffolds (BVS) in patients with stable angina and acute coronary syndromes. Polish National Registry. Kardiologia Polska; 72: 1394-1399.

Polish registry

N=591

In patients with ACS and those with complex lesions, early in-hospital results showed no significant differences between BVS and EES in the primary composite MACE end-point.

Large and recent studies included.

Sarno G, Onuma Y, Garcia-Garcia HM et al. (2010) IVUS radiofrequency analysis in the evaluation of the polymeric struts of the bioabsorbable everolimus-eluting device during the bioabsorption process. Catheterization and Cardiovascular Interventions 75: 914-918.

Case series

N= 20

Follow-up: 2 years

Authors conclude that a 24% seen decrease in necrotic core area between 6 months and 2 years could be due to bioabsorption and everolimus anti-inflammatory action,

Sub-study. Focus on imaging outcomes.

Sarno G, Bruining N, Onuma Y et al. (2012) Morphological and functional evaluation of the bioresorption of the bioresorbable everolimus-eluting vascular scaffold using IVUS, echogenicity and vasomotion testing at two year follow-up: a patient level insight into the ABSORB A clinical trial. International Journal of Cardiovascular Imaging 28: 51-58.

Case series

N =9

Follow-up: 2 years

Authors conclude that the return of endothelial and non-endothelial dependent vasomotion is associated with the bioresorption process.

Sub-study. Focus on imaging outcomes.

Serruys PW, Ormiston J, Onuma Y et al. (2009) A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2- year outcomes and results from multiple imaging methods. Lancet 373: 897-910.

Case series

N=29 patients with a single de-novo coronary artery lesion who had BVS.

Follow-up: 2 years.

At 2 years, there were no cardiac deaths, ischaemia-driven TLR, or stent thromboses and only 1 MI (non-Q wave). CT (in 25 patients) showed a mean diameter stenosis of 19%. At 2-year angiography, the in-stent late loss of 0·48 mm and the diameter stenosis of 27% did not differ from the findings at 6 months. The luminal area enlargement on OCT and IVUS between 6 months and 2 years was due to a decrease in plaque size without change in vessel size. At 2 years, 34·5% of strut locations presented no discernible features by OCT.

Reported in Table 2; shorter follow-up presented in this paper.

Shin E-S, Garcia-Garcia HM, Garg S et al. (2010) Assessment of the serial changes of vessel wall contents in atherosclerotic coronary lesion with bioresorbable everolimus-eluting vascular scaffolds using Shin's method: an IVUS study. International Journal of Cardiovascular Imaging 27: 931-937.

Case series

N = 29

Follow-up: 2 years

Authors conclude that virtual histology IVUS analysed using Shin's method can be used to assess bioresorption in those having a BVS.

Sub-study. Focus on imaging outcomes.

Shin E, Garcia-Garcia HM, Sarno G et al. (2010) Reproducibility of Shin's method for necrotic core and calcium content in atherosclerotic coronary lesions treated with bioresorbable everolimus-eluting vascular scaffolds using volumetric intravascular ultrasound radiofrequency-based analysis. International Journal of Cardiovascular Imaging 28: 43-49

Case series

N = 8

Follow-up: 2 years

Authors conclude that Shin's method showed good reproducibility.

Sub-study. Focus on imaging.

Sheehy A, Guitérrez-Chico JL, Diletti R et al. (2012) In vivo characterisation of bioresorbable vascular scaffold strut interfaces using optical coherence tomography with Gaussian line spread function analysis. EuroIntervention 7: 1227 – 1235.

N = 12

Follow-up: 6 months

Authors conclude that more precise assessment of strut thickness and coverage is possible with OCT with Gaussian line spread function analysis.

Sub-study. Focus on imaging outcomes.

Serruys P, Onuma Y Garcia-Garcia HM, et al. (2013) Dynamics of vessel wall changes following the implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention 9 (11):1271-1284.

Case series (ABSORB cohort B)

N=101 (45

cohort B1) and 56 cohort B2)

Follow-up 2 years

Between 1 and 3 years, late luminal loss remained unchanged (6 months: 0.19 mm, 1 year: 0.27 mm, 2 years: 0.27 mm, 3 years: 0.29 mm) and the in-segment angiographic restenosis rate for the entire cohort B (n=101) at 3 years was 6%. On IVUS, mean lumen, scaffold, plaque and vessel area showed enlargement up to 2 years. Mean lumen and scaffold area remained stable between 2 and 3 years. The 3-year MACE rate was 10% without any ScT.

Large and more recent studies included.

Serruys PW, Onuma Y, Dudek D et al. (2011) Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. Journal of the American College of Cardiology 58 (15): 1578-1588

Case series (ABSORB cohort B)

N=56 patients (57 scaffolds) 12-month follow-up

Overall the scaffold area remained unchanged, whereas the radiofrequency backscattering and the echogenicity of the struts decreased by 16.8% (p < 0.001) and 20% (p < 0.001), respectively. The angiographic late lumen loss amounted to 0.27 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12). The OCT at follow-up showed that 96.69% of the struts were covered and that malapposition, was only detected in 4 scaffolds. 2 patients experienced peri-procedural and iatrogenic MI, 2 had repeat intervention, resulting in the MACE rate of 7.1% (4/56).

Large and more recent studies included.

Serruys PW, Chevalier B, Sotomi Y, et al. Comparison of an everolimus-eluting bioresorbable

scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis

(ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial [Erratum

appears in Lancet 2017;389(10071):804;PMID: 28248178]. Lancet 2016;388(10059):2479–91

RCT Absorb BVS II

501

(335 versus

166) Everolimus-eluting BRS/Absorb® versus

everolimus-eluting permanent metallic

stent/Xience®

Follow-up 4 years.

The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb bioresorbable scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb scaffold. A higher rate of DOCE due to target vessel MI, including peri-procedural MI, was seen in the Absorb group. The POCE, anginal status, and exercise testing, were not statistically different between both devices at 3 years.

Included in systematic reviews

Serruys PW, Ormiston J, Geuns RJV et al. (2016) A polylactide bioresorbable scaffold

eluting everolimus for treatment of

coronary stenosis

5-year follow-up. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 67 (7), 766-776.

ABSORB B

N=101

5 years follow-up (n=50)

At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates.

Larger studies included.

Serruys PW, Chevalier B, Dudek D, et al. A bioresorbable everolimus-eluting scaffold versus

a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native

coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural

secondary outcomes from a randomised controlled trial. Lancet 2015;385(9962):43–54

RCT Absorb BVS II

501

(335 versus

166) Everolimus-eluting BRS/Absorb® versus

everolimus-eluting permanent metallic

stent/Xience®

Follow-up 4 years.

The 1-year composite device orientated endpoint was similar between the BRS and metallic stent groups (16 patients [5%] vs 5 patients [3%], p=0.35). Three patients in the BRS group had definite or probable scaffold thromboses, compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the BRS group compared with 5 (3%) events in the metallic stent group, with the most common adverse events being MI (15 cases [4%] versus 2 cases [1%], respectively) and clinically indicated TLR (4 cases [1%] vs 3 cases [2%], respectively).

Larger studies included.

Shreenivas S, Kereiakes DJ, Ellis SJ et al. (2017) Efficacy and Safety of the Absorb

Bioresorbable Vascular Scaffold in

Females and Males

Results of an Individual Patient-Level Pooled Meta-Analysis of

Randomized Controlled Trials. JACC: CARDIOVASCULAR INTERVENTIONS, 10 (18), 1881-1890

Meta-analysis of

RCTs

4 studies (n= 3,384 patients)

The 2-year rates of TLF with BVS versus everolimus-eluting stent in females were 8.9% versus 6.2% (HR 1.47; 95% CI: 0.88 to 2.46) and 8.9% versus 6.4% in males (HR: 1.40; 95% CI: 1.02 to 1.92; p interaction = 0.85). There were no significant interactions between sex and device type for any of the components of TLF.

Larger and more recent studies included.

Simsek C, Karanosos A, Magro M et al. (2016) Long-term invasive follow-up of the everolimus-eluting

bioresorbable vascular scaffold: five-year results of multiple

invasive imaging modalities. EuroIntervention;11:996-1003.

Patients included in the ABSORB cohort A

8 of 16 patients had imaging assessment.

At 5 years, the Absorb BVS is no longer discernible by any invasive imaging method and endothelial function is restored. Late luminal enlargement persists up to 5 years of follow-up without adaptive vessel remodelling.

Sub-study. Focus on imaging outcomes.

Simsek C, Magro M Onuma Y et al. (2013) Procedural and clinical outcomes of the Absorb everolimus-eluting bioresorbable vascular scaffold: one-month results of the Bioresorbable vascular Scaffold Evaluated At Rotterdam Cardiology Hospitals (B-SEARCH)

EuroIntervention 2013; 9-online publish-ahead-of-print September 2013

Case series, n=88 (92 lesions), Patients included in 3 study cohorts (ABSORB Cohort A, Cohort B and EXTEND) at 2 centres in Rotterdam

1month follow-up

Lesion length was significantly longer in the ABSORB EXTEND cohort 11.34mm (9.20mm; p<0.01) and RVD was smaller 2.53mm (2.87mm; p<0.001) compared to previous cohorts. The scaffold was successfully implanted in 90/92 lesions (97.8%). Post-dilatation was performed in 55% of the patients (53% EXTEND versus 56% Cohort A and B; p=0.7). The acute gain was 1.21mm. Absolute recoil was 0.16mm with percentage acute recoil of 5.60%. At 1 month, none of the patients had a MACE.

Study includes patients from Absorb A, B and extend study from 2 centres with 1 month follow-up.

Longer follow-up studies already included in table 2.

Sorrentino S, Giustino G, Mehran R et al. (2017) Everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents. Journal of the American College of Cardiology. 69: 3055-3066.

7 trials, n=5,583 patients were randomised to have either BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years).

There was a higher incidence of TLF (9.6% versus 7.2% with number needed to harm: 41; P < 0.003) and stent thrombosis (2.4% vs 0.7% with number needed to harm: 60; p <0.0001) in the BVS group. The increased risk for stent thrombosis was consistent across early (< 30 days), late (30 days to 1 year), and very late (> 1 year) periods.

More recent reviews included.

Stone GW, Gao R, Kimura T et al. (2016) 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled

meta-analysis. Lancet. 26; 387 (10025):1277-89.

Meta-analysis

4 RCTs BVS Absorb

Pooled analysis of individual patient data from the 4industry-sponsored studies showed broadly concordant findings. Most of this increased risk occurred inside the first 30 days suggesting an association with the procedural outcomes. In this meta-analysis, BVS did not lead to different rates of POCE and DOCE adverse events at 1-year follow-up compared with CoCr-EES.

Meta-analysis

Stone GW, Abizaid A, Onuma Y, Seth A, Gao R, Ormiston J, et al. Effect of Technique on Outcomes Following Bioresorbable Vascular Scaffold Implantation: Analysis From the ABSORB Trials. J Am Coll Cardiol 2017;70:2863−74

Retrospective analysis

N=2,973 patients with 3,149 BVS-treated coronary artery lesions from 5 prospective studies (ABSORB II, ABSORB China, ABSORB Japan, ABSORB III, and ABSORB Extend). Outcomes through 3 years

In the present large-scale analysis from the major ABSORB studies, after multivariable adjustment for baseline patient and lesion characteristics, vessel sizing and operator technique were strongly associated with BVS-related outcomes during 3-year follow-up.

Large and recent studies included.

Sotomi Y, Suwannasom P, Serruys PW et al. (2017) Possible mechanical causes of scaffold thrombosis: insights from case reports with intracoronary imaging. EuroIntervention; 12: 1747- 1756.

Review

Insights into the possible mechanical causes of ScT in early and late phases with data stemming from intracoronary imaging (IVUS and OCT) of the currently published ScT cases following the implantation of BVS and reviewed practical recommendation for implantation of the BVS made by a group of experts.

Large and recent studies included.

Tanimoto S, Bruining N, van Domburg RT et al. (2008). Late stent recoil of the bioabsorbable everolimus-eluting coronary stent and its relationship with plaque morphology. Journal of the American College of Cardiology 52 (20): 1616 – 1620.

Case series

N = 16

Follow-up: 6 months

Authors report late BVS recoil of 23% although the type of lesion morphology may have affected the degree to which this occurred.

Sub-study. Focus on imaging outcomes.

Toušek P, Kočka V, Malý M et al. (2016) Long-term follow-up after bioresorbable vascular scaffold implantation in STEMI patients: PRAGUE-19 study update. EuroIntervention;12(1):23-9.

N=117 STEMI patients with BVS.

mean follow-up 730±275 days

Overall mortality of 4.4%. Definite ScT occurred in 2 patients in the early phase after BVS implantation; there was no late thrombosis. VS struts were still visible at 3 years and 99.4% of them were well apposed and covered.

Large studies included.

Tousek P, Kocka V, Maly M et al. (2016) Two-year follow-up after bioresorbable vascular scaffold implantation in STEMI patients — Results from PRAGUE-19 study. International Journal of Cardiology 209; 20–21.

Prospective study

BVS group (n = 40), versus control DES group (n=57)

2 year follow-up

No differences in primary composite endpoint during the 2 year follow-up have been found between the BVS and control group (7,5% versus 18.9%; P = 0.141). Regarding functional clinical status, no differences were seen in NYHA and CCS class at 2 year follow-up. There was 1 acute definitive stent thrombosis in the BVS group already presented in the short-term clinical follow-up of the study. No other definitive/probable stent thrombosis occurred in both groups up to the 2 year follow-up.

Large and recent studies included.

Tarantini G, Masiero G, Fovino LN, et al. (2018) "Full-plastic jacket" with everolimus-eluting Absorb

bioresorbable vascular scaffolds: clinical outcomes in the multicenter prospective RAI

registry (NCT02298413). Int J Cardiol; 266:67–74.

RAI Registry

N=1384 patients compared those related with 'full-plastic jacket' (FPJ) everolimus-eluting Absorb BRS (>56 mm of overlapping BRS in at least 1 vessel) versus non FPJ

21.6 months follow-up

At a median follow-up of 649 days, no differences were seen between full-plastic jacket' [FPJ] and non-FPJ groups in terms of the D0CE (5.6% versus 4.4%, p = 0.675) or PoCE (20.9% versus 15.9%, p = 0.149). Patients having FPJ had higher rates of target vessel repeat revascularisation (TVR) (11.2% versus 6.3%, p = 0.042). In the FPJ group, there was no cardiac death and only 1 (very late) stent thrombosis (ST) (0.7%).

Larger and more recent studies included.

Tamai H, Igaki K, Kyo E et al. (2000) Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. Circulation 102: 399-404.

Case series

N=15

PLLA Igaki-Tamai stent implantation 

Follow-up: 6 months

Our preliminary experience suggests that coronary PLLA biodegradable stents are feasible, safe, and effective in humans. Long-term follow-up with more patients will be required to validate the long-term efficacy of PLLA stents.

Patients included within larger study with longer follow-up.

Tanimoto S, Serruys PW, Thuesen L, et al. (2007) Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: Insights from the ABSORB and SPIRIT trials. Catheterization and Cardiovascular interventions 70: 515 – 523.

Case series

N=27 (BVS) versus 27(DES)

Authors conclude that in some patients, BVS acute stent recoil of the BVS was slightly larger but not significantly different from that of a DES.

Sub-study.

Focus on imaging outcomes.

Tijssen RYG, Kraak RP, Elias J et al. (2018) Implantation techniques (predilatation, sizing, and post-dilatation) and the incidence of scaffold thrombosis and revascularisation in lesions treated with an everolimus-eluting bioresorbable vascular scaffold: insights from the AIDA trial. EuroIntervention; 14:e434−e42.

Retrospective analysis of Absorb BVS Absorb-treated AIDA patients

implantation in 1,074 lesions 158 (14.7%) lesions met PSP criteria.

Definite stent thrombosis occurred in 4/158 PSP-treated lesions compared with 27/916 non PSP-treated lesions, with 2-year KM estimates of 3.0% versus 4.1% and an HR of 1.14 (p=0.811). TLR occurred in 8/158 PSP-treated lesions compared with 61/916 non PSP-treated lesions, with KM estimates of 5.6% versus 7.1% and an HR of 1.29 (p=0.492). Scaffold implantation according to an optimised PSP protocol did not result in lower stent thrombosis or TLR rates.

Large and recent studies included.

Toyota T, Morimoto T, Shiomi H et al. (2017) Very late scaffold thrombosis of

bioresorbable vascular scaffold

systematic review and a meta-analysis. JACC: CARDIOVASCULAR INTERVENTIONS, 10 (1), 27-37.

Meta-analysis of 24 studies (BVS: n =2,567 and EES: n =19,806) reporting the 2-year outcomes of BVS and/or EES to compare the risk of BVS versus EES for stent/ScT (ST) and target lesion

failure (TLF) in 7 comparative studies (3 randomised and 4 observational), and to estimate the pooled incidence rates of

ST and TLF including additional 17 single-arm studies.

In the 7 comparative studies, the risk for VLST between 1 and 2 years was numerically higher in BVS than in EES ( OR: 2.03 [95% CI: 0.62 to 6.71]). The excess risk of BVS relative to EES for ST through 2 years was significant (OR: 2.08 [95% CI: 1.02 to 4.26]). The risk for TLF was neutral between BVS and EES. In the 24 studies, the pooled estimated incidence rates of VLST, and ST through 2 years were higher in BVS than in EES

(0.240 [95% CI: 0.022 to 0.608]% versus 0.003 [95% CI: 0.000 to 0.028]%, and 1.43 [95% CI: 0.67 to 2.41]% versus 0.56 [95% CI: 0.43 to 0.70]%, respectively). The corresponding rates for TLF were comparable between BVS and EES (1.88 [95% CI: 1.30 to 2.55]% and 1.78 [95% CI: 1.17 to 2.49]% and 7.90 [95% CI: 6.26 to 9.69]% and 7.49 [95% CI: 5.86 to 9.29]%, respectively).

Large and recent studies included.

Xu B, Yang Y, Han Y et al. (2017) Comparison of everolimus eluting bioresorbable vascular scaffolds and metallic stents: three-year clinical outcomes from the ABSORB China randomised trial. EuroIntervention. 22. Pii: EIJ-D-17-00796.

RCT absorb China

N=480 patients with 1 or 2 native coronary artery lesions were randomised 1:1 to BVS (N=241) versus CoCr-EES (N=239).

In the ABSORB China trial, BVS and CoCr-EES had similar results up to 3-year follow-up, the time at which the scaffold has completely resorbed. BVS outcomes may be further optimised by appropriate lesion selection and implantation technique.

Large and more recent studies included.

Verheye S, Woldarczak A, Montorsi P et al. (2021) BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients. Catheter Cardiovasc Interv; 98:E1–E8.

BIOSOLVE-IV international registry

N= 1,075 patients with 1,121 lesions who had Magmaris BVS

Follow-up 12 months.

BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.

Longer follow-up studies included.

Verheye S, Costa RA, Schofer J et al. (2019) Five-year safety and performance data of a novel third-generation novolimus-eluting bioresorbable scaffold in single de novo lesions. EuroIntervention 2019;15:685-687

DESolve nonrandomised study

n= 126 patients with a de novo lesions treated with BVS

2 years follow-up

After the 2-year follow-up, 2 patients were lost to follow-up. Two patients had a major adverse cardiac event (MACE) - a cardiac death at 3 years and a target vessel-related non-Q-wave MI due to a proximal target segment stenosis treated with a stent at 4 years. The cumulative MACE rate at f5ive years was 9.0%. There were no reported definite scaffold thromboses.

Larger studies included.

Vijayvergiya R, Reviah PC, Kasinadhuni G et al. (2020) In-scaffold neovascularization of a bioresorbable vascular scaffold after 6 years of implantation. European Heart Journal - Case Reports, 4, 1–2

Case report n=1 patient with chronic stable angina stented with a bioresorbable vascular scaffold (BVS)

Patient remained asymptomatic for the next 6 years. OCT findings at 6 years were consistent with the formation of neovascular channels within the neo plaque after BVS implantation.

Larger studies included.

Vandeeper M (2016) Bioresorbable vascular scaffolds for coronary artery disease. Technology brief update. Health Policy Advisory Committee on Technology (HealthPACT). Australian Safety and Efficacy Register of

New Interventional Procedures – Surgical (ASERNIP-S)

The currently available evidence raises some doubts as to whether patient outcomes with the BVS technology are equivalent in effectiveness and safety compared to those achieved in patients treated with conventional DES. In addition, HealthPACT noted that the Absorb Bioresorbable Vascular Scaffold System is listed on the Prostheses List (AY045) at an equivalent price to drug eluting coronary artery stents, with a list price of $3,450, which is significantly higher than the negotiated price in the public sector.

Vanhaverbeke M, McCutcheon K, Dubois C et al. (2018) Long-term intravascular follow-up of coronary bifurcation treatment with

Absorb bioresorbable vascular scaffold. ACTA CARDIOLOGICA, 73,4, 413–414

Case report

N=1 patient treated with modified-T stenting of a true bifurcation lesion

the bifurcation lesion was successfully treated with implantation of BVS. The patient remained angina free at 30 months. Angiography and OCT revealed complete restoration of the bifurcation anatomy and excellent vessel-wall healing characteristics at 30 months.

Larger studies included.

Verdoia M, Kedhi E, Suryapranata H et al. (2020) Poly (L-lactic acid) bioresorbable scaffolds versus metallic drugeluting stents for the treatment of coronary artery disease: A

meta-analysis of 11 randomized trials. Catheter Cardiovasc Interv; 96:813–824.

Meta-analysis

11 randomised trials, for a total population of 10,707 patients,

54.5% treated with BVS

mean follow-up of 2.64 years (1–5 years)

Mortality occurred in 2.71% of the patients, with no difference according to the type of implanted stent (OR[95%CI] = 0.94 [0.74, 1.20], p = .62). No interaction was seen according to patients' risk profile or the rate of diabetes and ACS. However, a significant increase in MI, stent thrombosis, TLR and TLF was seen with BVS as compared to DE.

More recent reviews included.

Waksman R, Erbel R, Di Mario C et al. (2009). Early- and long-term intravascular ultrasound and angiographic findings after bioabsorbable magnesium stent implantation in human coronary arteries. JACC: Cardiovascular Interventions 2 (4): 312-320.

N = 63

Follow-up: 20.3 months

Authors report that degradation occurred at 4 months with durability of results without early or late adverse findings.

Sub-study. Focus on imaging outcomes.

Waksman R, Prati F, Bruining N et al (2013). Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment.

Circulation: Cardiovascular Interventions 6 (6) 644-653.

N=46

BIOSOLVE-I

Case series

12 months follow-up

Arterial curvature and angulation significantly increased by the degradation. Vasoconstriction was seen at 6 months. The percent hyper echogenicity of the scaffolded segments decreased in the first 6 months (from 22.1 to 15.8%; p<0.001). Struts on OCT at 6 and 12 months showed full neointimal coverage, with stabilisation of the mean scaffold area from 6 to 12 months. The mean neointimal area (1.55 versus 1.58mm(2); p=0.794) remained unchanged from 6 to 12 months.

Study reports mainly angiographic, IVUS and OCT outcomes.

Clinical outcomes from related paper reported in table 2

Wiebe J, Hoppmann P, Colleran R et al. (2017) Long-term clinical outcomes of patients treated with everolimus-eluting bioresorbable stents in routine practice: 2-year results of the ISAR-ABSORB registry. JACC Cardiovasc Interv. 26;10(12):1222-1229.

ISAR-ABSORB registry.

419 patients

In the ISAR-ABSORB registry, at 2 years, the primary endpoint had occurred in 21.6% of patients: death in 6.3%, MI in 3.9%, TLR in 16.0%, and definite stent thrombosis in 3.8%. Long-term follow-up of patients treated with BRS in routine practice showed higher event rates than expected.

Large and recent studies included.

Wykrzykowska JJ, Kraak RP, Hofma SH, et al. (2017) Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med; 376:2319-28.

ADIA trial

1845 patients (with either a BVS 924 patients or a DES 921 patients)

median follow-up was 707 days.

 There was no significant difference in the rate of target-vessel failure between the patients who had a bioresorbable scaffold and the patients who had a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up. 

Large and recent studies included.

Woldarczak A, Gracia LAI, Karjalailen PP et al. (2019) Magnesium 2000 postmarket evaluation: Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold. Cardiovascular Revascularization Medicine, 20, 12, 1140-1145

Review of 2000 procedures Magmaris postmarket program (survey)

The Magmaris 2000 program includes the first commercial cases at each hospital. Overall, data on 2018 implantations were collected. The high rate of pre- and post-dilatation as well as other parameters confirm that generally the implantation guidelines are adhered to and the good intraprocedural performance (rated as good or very good in 96%) confirm the theoretical advantages of a metallic scaffold in practice.

More relevant studies included.

Woudstra P, Grundeken MJ, Kraak RP et al (2014).

Amsterdam Investigator-initiated Absorb strategy all-comers trial (AIDA trial): A clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: Rationale and study design.

American Heart Journal 167 (2) 133-140.

RCT

Absorb BVS vs XIENCE DES

The AIDA trial is a prospective, randomised (1:1), active-control, single-blinded, all-comer, non-inferiority trial. A total of 2,690 subjects will be enrolled with broad inclusion and limited exclusion criteria according to the "Instructions for Use" of the Absorb BVS strategy. The study population includes both simple and complex lesions, in patients with stable and ACS. The follow-up continues for 5years. The primary end point of the trial is TVF, defined as the composite of cardiac death, MI, and target vessel revascularization, at 2 years.

Study protocol only. Results not reported yet.

Wiebe J (1), Möllmann H, Most A et al (2013). Short-term outcome of patients with ST-segment elevation myocardial infarction (STEMI) treated with an everolimus-eluting bioresorbable vascular scaffold. Clin Res Cardiol. 2014 Feb; 103 (2):141-8. Doi: 10.1007/s00392-013-0630-x. Epub 2013 Oct 18.

Patients with ST-segment elevation myocardial

infarction (STEMI).

N=25 (31 lesions)

Case series

ABSORB BVS

132 days follow-up.

Procedural success was achieved in 97 %. 2 MACE occurred during hospitalisation and follow-up: 1 patient with cardiogenic shock at the index procedure subsequently died. 1 patient suffered from instable angina with need for interventional revascularisation of a previously untreated vessel. 1 TVF as a consequence of an intra-procedural dissection was seen. However, no TLF was noted and no patients died.

Similar study included in table 2

Wiebe J, Dorr O, Ilstad H et al. (2017) Everolimus-versus novolimus-eluting bioresorbable scaffolds for the treatment of coronary artery disease:

a matched comparison. JACC Cardiovasc Interv; 10:477–485.

Comparative analysis between the DESolve BRS and the

Absorb BRS using a propensity-score matching model.

The main finding was that outcomes at 1 year were similar between the 2 devices: the 1-year rates of TLF (4.7 versus 4.5%; p = 0.851), TLR (2.6 versus 3.5%; p = 0.768), cardiac death (1.5 versus 2.0%; p = 0.752), and

definite stent/ScT (2.0 versus 1.0%;

p= 0.529) did not differ significantly between Absorb BRS and DESolve BRS. 6-month angiographic follow-up, the novolimus-eluting bioresorbable DESolve scaffold showed in-stent

late lumen loss of 0.20 mm.

Large and more recent studies included.

Wohrle J, Naber C, Schmitz T et al. (2015) Beyond the early stages: insights from the ASSURE registry on bioresorbable vascular scaffolds.

Assure registry

N=183 patients with de novo CAD

procedural success was achieved in all patients. Acute gain was 1.54±0.51 mm, resulting in a final minimal lumen diameter (MLD), which met the baseline RVD, although visual estimates overrated the RVD by 0.5±0.5 mm. Up to 12 months, 1 patient (0.5%) had died from gastrointestinal bleeding, 3 (1.7%) non-target vessel MIs occurred, and 5 (2.8%) TLR had become necessary because of restenosis.

Larger studies included.

Ke J, Zhang H, Huang J et al. (2020) Three-year outcomes of bioresorbable vascular scaffolds versus second-generation drug-eluting stents. Medicine. 99: e21554.

Meta-analyses of 6 RCTs with 3 years follow-up -5,412 patients (BVS n = 3,177; DES n = 2,235),

At 3 years, BVS was associated with higher rates of TLF (OR = 1.33, 95%CI: 1.10-1.60, P = 0.003) and definite/probable stent/ScT (OR = 3.75, 95% CI: 2.22-6.35, P < .00001)compared with DES. The incidence of target vessel MI (OR = 1.68, 95% CI: 1.30-2.17, P < .0001), ischemia-driven TLR (OR = 1.46, 95% CI: 1.14-1.86, P = .003), and the POCE (OR = 1.20, 95% CI: 1.04-1.39, P = .01) were higher for those treated with BVS compared with DES. However, there was no significant difference in risk of cardiac death (OR = 0.94, 95%CI: 0.61-1.45, P = .79) between treatment groups.

Large and recent studies included.

Zhang XL, Zhu L, Wei ZH et al. (2016) Comparative efficacy and safety of everolimus eluting bioresorbable scaffold versus everolimus-eluting metallic stents: A systematic review and meta-analysis. Ann Intern Med; 164(11):752-6

Meta-analysis

6 randomised, controlled trials and 38 observational studies, each involving at least 40 patients with BVS implantation

The pooled incidence of definite or probable stent thrombosis after BVS implantation was 1.5 events per 100 patient-years (PYs) (95% CI, 1.2 to 2.0 events per 100 PYs) (126 events during 8508 PYs). Six randomised trials that directly compared BVSs with EESs showed a non-statistically significant increased risk for stent thrombosis (OR, 2.05 [CI, 0.95 to 4.43]; P = 0.067) and MI (OR, 1.38 [CI, 0.98 to 1.95]; P = 0.064) with BVSs. The 6 observational studies that compared BVSs with EESs showed increased risk for stent thrombosis (OR, 2.32 [CI, 1.06 to 5.07]; P = 0.035) and MI (OR, 2.09 [CI, 1.23 to 3.55]; P = 0.007) with BVSs. The relative rates of all-cause and cardiac death, revascularisation, and TLF were similar for BVSs and EESs.

More recent reviews included.

Zhang H, Zhao J, Xu Y et al. (2019) Three-year outcome of everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stents: a comprehensive updated meta-analysis of randomized controlled trials. EXPERT REVIEW OF MEDICAL DEVICES, 16, 5, 421–427

Meta-analysis

N=6 studies [5,474 patients] Most studies were randomised multicentre trials with over 2-years follow-up. The experimental group was ABSORB EE-BRS and the control group was EES.

There was no difference regarding DOCEs, POCEs and ID-TLRs for 1 or 2 years, whereas

there were significant differences regarding thrombosis between EE-BRS and EES interventions in the 1-year

(pooled HR, 2.15, 95%CI: 1.11, 4.18) and 2-year follow-ups (pooled HR, 2.02, 95%CI: 1.08, 3.78), but not in the

3-year follow-up (pooled HR, 1.57, 95%CI: 0.66, 3.75) anymore. The results of this study showed no inferiority

of EE-BRS regarding TVF, DOCE, POCE and ID-TLR 1-year and 2-years after interventions, but enhanced risk of

thrombosis in the EE-BRS patients, which disappeared in 3-year follow-ups

More recent reviews included.

Zasada W, Rzeszutko L, Dziewierz A, and Dudek D. (2013) Patient with non-ST-segment elevation myocardial infarction treated by Absorb bioresorbable scaffold implantation.

Kardiologia Polska. 71 (10), 1091-1092.

Case report

n=1

Patient with non-ST segment elevation MI

We present the case of a 57-year-old male patient with a diagnosis of non-STE MI. Taking into consideration the clinical presentation and angiographic findings, the patient was qualified for emergent PCI with aspiration thrombectomy and bioresorbable vascular scaffold implantation (BVS; Absorb, Abbott), with good angiographic result.

Case study

Larger studies with longer follow-up included in table 2.

Zechmeister-Koss I, Rothschedl E. (2015) Fully bioresorbable scaffolds for coronary artery disease. Decision Support Document

Nr. 81; Vienna: Ludwig Boltzmann Institute for Health Technology Assessment.

Systematic review

The current evidence is not sufficient to prove that the BVS is more or at least equally effective and safer than current revascularisation technologies. Hence, the inclusion in the catalogue of benefits is currently not recommended.

More recent studies included.