Interventional procedure overview of bioresorbable stent implantation to treat coronary artery disease
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Summary of key evidence on bioresorbable stent implantation to treat coronary artery disease
Study 1 IAMEV, SNSPMPDSB 2019
Study type | HTA |
Country | Europe, New Zealand, USA, Australia, Japan, Singapore, Egypt, India |
Search period | Search period -inception to 2018 |
Study population and number | n=53 studies of 22295 adult patients with CAD, including stable angina, unstable angina, and/or MI, who require and are eligible for myocardial revascularisation. [8 RCTs with 5863 patients covered across 18 articles and 45 uncontrolled cohort trials with 16432 patients covered across 71 articles] |
Age and sex | RCTs: mean age range 57-67 years, 70-80% male Uncontrolled cohort studies: mean age range 54-66 years, 60-90% male |
Study selection criteria | Inclusion criteria: Randomised clinical trials, prospective non-RCTs; prospective (single-arm) observational studies (e.g., case series), and registries with at least 50 patients involving PCI with implantation of a fully bioabsorbable, biodegradable or bioresorbable vascular scaffold or stent (BRS) Exclusion criteria: No primary study included in paper, no full-text publication available, no relevant outcomes, in language other than English/German/French/Spanish, cohort study not prospectively planned, cohort study <50 patients |
Technique | RCTs: Patients were randomly assigned to ABSORB everolimus-eluting PLLA bioresorbable vascular scaffold (BVS) system (Abbott Vascular, Santa Clara, CA, USA) or metallic drug-eluting stents (DES) and the corresponding scaffold was implanted. Uncontrolled cohort trials: Patients were implanted with one of the following bioresorbable vascular scaffolds (BVS) depending on the study: ABSORB everolimus-eluting PLLA BVS system (Abbott Vascular), DESolve novolimus-eluting PLLA BVS (Elixir Medical Corporation), DREAMS 2G (commercial name Magmaris) sirolimus-eluting magnesium bioresorbable scaffold (Biotronik AG), Fantom sirolimus-eluting BVS (REVA Medical). |
Follow-up | RCTs: 6 months-4 years Uncontrolled cohort trials: average follow-up 12-24 months, maximum reported follow-up 5 years |
Conflict of interest/source of funding | This study was funded by a grant from the European Commission. No conflicts of interest reported. |
Analysis
Follow up issues: Follow-up varies across studies and data was analysed as reported by individual studies.
Study design issues: The HTA Core Model Application for Rapid Relative Effectiveness Assessment (REA; 4.2) was the primary source for selecting assessment elements.
To identify primary studies containing information about efficacy and safety within the scope of the HTA, systematic literature searches were conducted using Medline, PubMed, Embase and the Cochrane Central Register of Controlled Trials. In addition, authors searched the Cochrane Database for Systematic Reviews for topic-related review articles. References from relevant original articles and reviews were hand-searched to identify additional primary studies. A search for relevant ongoing studies was also conducted using clinical trial registries ClinicalTrials.gov and World Health Organisation (WHO)-International Clinical Trials Registry Platform (ICTRP). Two researchers independently screened entries, and in the case of disagreements, a third researcher was involved to resolve the differences.
Risk of bias at the study level and endpoint level for RCTs was assessed using the Cochrane risk of bias tool. Risk of bias at the study level for the single-arm studies was assessed using the Institute of Health Economics (IHE) 20-Criteria checklist. Two reviewers performed the risk of bias assessment independently and disagreements were resolved by consensus.
The quality of the body of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology in which "high" = further research is very unlikely to change confidence in the estimate of effect, "moderate" = further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate, "low" = further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate, and "Very low" = extreme uncertainty about the estimate.
Study population issues: Patients in the included studies (RCTs and single-arm studies) were predominantly male with and aged 60 to 70 years - generalisability to females and other age groups is limited. Most of the included study population had relatively simple lesions in contrast to patients with more complex lesions frequently encountered in daily practice.
Other issues: All effectiveness data and the majority of safety data reported in this HTA comes from studies using Absorb BVS; there are few studies related to other BVS devices included. Only 3/53 studies analysing 1.5% of the total patient population (345/22295) included in this HTA report outcomes relating to the DESolve BVS, 2/53 studies and 0.8% of the patient population (184/22295) report Magmaris BVS outcomes, and 1/53 studies and 1.1% of the patient population (184/22295) report Fantom BVS outcomes.
There is some overlap of primary studies between the systematic reviews and meta-analyses and HTA1-4.
Key efficacy findings
Number of patients analysed: 5863 (across 8 RCTs comparing Absorb BVS with DES; 3362 Absorb versus 2502 DES)]
Summary of mortality and MI outcomes
Outcome | Anticipated absolute effects (95% CI) | Relative effect (95% CI) | P-value | Number of participants across studies reporting outcome | Quality of studies according to GRADE | |
Risk with DES | Risk with Absorb BVS | |||||
All-cause mortality (2-4 years follow-up) | 38 per 1000 | 32 per 1000 (24-43) | RR 0.84 (0.63–1.11) | 0.22 | 5645 | Moderatea |
All-cause mortality (≥3 years follow-up) | 41 per 1000 | 34 per 1000 (26-46) | RR 0.82 (0.62–1.10) | 0.19 | 5001 | Moderatea |
Cardiac mortality (6 months-4 years follow-up) | 16 per 1000 | 15 per 1000 (10-23) | RR 0.91 (0.60–1.39) | 0.68 | 5830 | Moderatea |
Cardiac mortality (≥3 years follow-up) | 18 per 1000 | 16 per 1000 (11-25) | RR 0.89 (0.58–1.38) | 0.61 | 5185 | Moderatea |
MI (1–4 years of follow-up) | 49 per 000 | 73 per 1000 (60-91) | RR 1.49 (1.21–1.84) | 0.0002 | 5845 | High |
MI (≥3 years follow-up) | 53 per 1000 | 77 per 1000 (62-96) | RR 1.44 (1.16–1.80) | 0.001 | 5001 | High |
a = Imprecision was downgraded by 1 point because of a non-significant effect estimate with wide CI
All MI
Meta-analysis including results from the maximum length of follow-up in 8 RCTs showed statistically significant higher rates of MIs for patients who had Absorb BVS compared with patients who had permanent metal DES [RR 1.49 (95% CI 1.21-1.84); p=0.0002; 0% heterogeneity]. Limiting analysis to studies with at least 3 years of follow-up (5 RCTs) did not change the significance of the results [RR 1.44 (95% CI 1.16–1.80); p=0.001; 0% heterogeneity].
Angina
Angina as an endpoint was reported in 3 RCTs. In 1 study, the percentage of patients reporting angina after 1 year of follow-up was 18.3% in the Absorb BVS group and 18.4% in the permanent metal DES group. In the other 2 RCTs, the percentage of patients free of angina was assessed using the Seattle Angina Questionnaire, with no difference between the study groups (74% versus 73% after 3 and 91.4% versus 91.7% after 6 months, respectively).
MACE
Meta-analysis including results from the maximum length of follow-up in 4 RCTs (including 3,200 patients with a maximum 5-year follow-up) showed statistically significant higher rates of MACE (comprised of cardiac death, all MI, and ischaemic-driven TLR (ID-TLR)) in patients who had Absorb BVS (n=1,962) compared with patients who had permanent metal DES [n=1,238; RR 1.36 (95% CI 1.06–1.73); p=0.01; 0% heterogeneity].
POCE
Meta-analysis including results from the maximum length of follow-up in 5 RCTs (n=5,449 patients and with 5-year maximum follow-up) showed statistically significant higher rates of POCE (comprised of all death, all MI, and all revascularisations) in patients who had Absorb BVS (n=3,153) compared with patients who had permanent metal DES [n=2,296; RR 1.36 (95% CI 1.06–1.73); p=0.01; 0% heterogeneity].
TLR
In a meta-analysis for all-TLR after a maximum length of follow-up in 8 RCTs, the rate of TLR was significantly higher in the Absorb BVS group than in the DES group [RR 1.36 (95% CI 1.08–1.71); p=0.009; 0% heterogeneity].
TVR
In a meta-analysis for all-TVR after a maximum length of follow-up in 8 RCTs, the rate of TVR was significantly higher in the Absorb BVS group than in the DES group [RR 1.18 (95% CI 0.98–1.41); p=0.08; I2=0% heterogeneity].
Other efficacy findings
1 RCT (Absorb II) reported outcomes linked to 'physical limitation' (as defined by the Seattle Angina Questionnaire), which increased in both study groups from baseline (75 patients versus 72 patients; p=0.77) to 1-year follow-up (87 patients versus 86 patients; p=0.48) and remained constant for the following 2 years (at 3-year follow-up: 87 patients versus 86 patient; p=0.54). There was no significant difference between patients in the Absorb BVS group and patients in the DES group.
2 RCTs reported that there was no significant difference in quality of life outcomes (as defined by the Seattle Angina Questionnaire) between the Absorb BVS and DES groups after 1, 2 or 3 years (76 pts vs 74 pts; p=0.47) and 1 year (87 patients versus 86 patients; p=not reported), respectively.
Key safety findings
Number of patients analysed: 22,295
Absorb BVS safety outcomes
Summary of Absorb safety findings – across all studies
Outcome | Number of studies reporting outcome (n=patients) | Anticipated absolute effects | Relative effect (95% CI) | P value | Quality of studies (according to GRADE) | |
Risk with DES | Risk with Absorb BVS | |||||
Periprocedural MI | 7 (n=5503) | 60 per 1000 | 73 per 1000 (49-109) | RR 1.22 (0.82–1.82) | 0.32 | Moderatea |
Mortality as a result of bleeding or stroke (6–60 months follow-up) | 11 (n=1402) | 2 deaths across all Absorb groups – absolute and relative risk not calculated | Very lowb | |||
Very late ScT (after at least 1 year of follow-up) | 6 (n =5549) | 7 per 1000 (3-17) | 1 per 1000 | RR 5.09 (1.97 to 13.17) | 0.0008 | Moderatea |
a = Imprecision was downgraded by 1 point because of a non-significant effect estimate with wide CI
b = Risk of bias was down-graded by 2 points because of study design and study quality (observational single-arm studies with predominantly moderate to high risk of bias
Frequency and severity of adverse events in ABSORB RCTs
RCT | AIDA | TROFI II | Everbio II | Hernandez | |||||
Adverse events | Absorb BVS (n=924) | EES (n =921) | Absorb BVS (n=78) | EES (n=80) | Absorb BVS (n=78) | EES (n=80) | BES (n=80) | Absorb BVS (n=100) | EES (n=100) |
Very late (after ≥1 year) ScT and/or stent thrombosis and its consequences, n (%) | 1.5 (14/294) | 0.3 (3/921) | - | - | 0 | 0 | 0 | - | - |
Periprocedural MI | 1.0 (9/924) | 0.7 (6/921) | 0 | 0 | - | - | - | - | - |
Total SAEs % (n) | - | - | - | - | - | - | - | - | - |
Total deaths % (n) | 4.4 (41/924) | 5.3 (49/921) | 2.1 (2/78) | 5 (4/80) | 3 (2/78) | 5/(4/80) | 1 (1/80) | 1 (1/100) | 1 (1/100) |
not reported for study
RCT | Absorb II | Absorb III | Absorb Japan | Absorb China | ||||
Adverse events | Absorb BVS (n=335) | EES (n = 166) | Absorb BVS (n=1322) | EES (n=686) | Absorb BVS (n=266) | EES (n=134) | Absorb BVS (n=241) | EES (n=239) |
Very late (after ≥1 year) ScT and/or stent thrombosis and its consequences, n (%) | 1.8 (6/335) | 0 | 0.8 (10/1322) | 0 | 1.6 (4/266) | 0 | 0.4 (1/241) | 0 |
Periprocedural MI | 4 (13/335) | 1 (2/166) | 3.1 (41/1322) | 3.2 (22/686) | 1.1 (3/266) | 1.5 (2/134) | 1.3 (3/241) | 0.4 (1/239) |
Total SAEs % (n) | - | - | 30.1 (398/1322) | 28,9 (198/686 | - | - | 18.7 (45/241) | 19.3 (46/239) |
Total deaths % (n) | 3.2 (11/335) | 4.7 (8/166) | 3.1 (40/1322) | 3.4 (23/686) | 1.5 (4/266) | 0 | 0.8 (2/241) | 2.6 (6/239) |
not reported for study
Meta-analysis of periprocedural MI
In a meta-analysis of 7 RCTs, there was no statistically significant increased risk in the rate of periprocedural MI in the Absorb BVS groups compared with permanent metal DES [RR 1.22 (95% CI 0.82–1.82); p=0.32; 0% heterogeneity].
Meta-analysis of very late ScT (>1 year)
In a meta-analysis of 6 RCTs (including 5,450 patients), there was a statistically significant increased risk in the rate of ScT that occurred after at least 1 year of follow-up (very late ScT) in the Absorb BVS group(n=3,152) compared with permanent metal DES [n=2,298; RR 5.09 (95% CI 1.97–13.17); p=0.0008; 0% heterogeneity].
Subgroup analysis of late ScT in different patient groups (stable CAD vs ACS)
A subgroup analysis on very late ScT (≥1 year follow-up) comparing RCTs where most of the included patients (60% or more) had stable angina and those in which most patients had ACS (60% or more) showed no statistically significant subgroup difference.
Safety outcomes for all other devices
Outcome | Device | ||
DESolve (n=345 across 3 studies) | Magmaris (n=184 across 2 studies) | Fantom (n=117 across 1 study) | |
Periprocedural mortality % (n) | 0 (0/345) | 0 (0/184) | 0 (0/117) |
Periprocedural MI % (n) | 0.29 (1/345) | 0 (0/184) | 0.85 (1/117) |
Mortality as a result of bleeding or stroke | 0 (0/219) across 2 studies* | 0 (0/184) | 0 (0/117) |
Very late ScT (after at least 1 year of follow-up) | 0 (0/126) across 1 study* | 0 (0/123) across | Not available (only 6-month follow-up) |
*Outcome not reported in all studies
Quality of evidence according to GRADE assessment was deemed "very low" for all safety outcomes outlined above for DESolve, Magmaris and Fantom devices due to very low event rates in the studies and/or a high risk of bias.
Study 2 Ni L (2020)
Study type | Systematic review and meta-analysis |
|---|---|
Country | China |
Search details | Search period; from inception to October 2018; databases searched: PubMed, Springer, EMBASE, Wiley-Blackwell, and Chinese Journal full-text database. In addition, reference list of each article retrieved were also reviewed. |
Study population and number | 10 studies with 6383 patients with CHD. 3573 with bioresorbable stents (BRS) versus 2810 with drug-eluting stents (DES). |
Age and sex | Age range- mean 56.7 to 64.3 years; sex not reported. |
Study selection criteria | Inclusion criteria: RCTs or prospective controlled clinical trials; comparing treatment between BRS and DES. Exclusion criteria: observational studies, studies on other treatments other than BRS or DES, other indications, studies lacking outcome measures or comparable results, duplicate and incomplete studies. |
Technique | PCI with stents (Absorb BRS or DES). |
Follow-up | Varied across included studies (30 days to 5 years), mean 3 years. |
Conflict of interest/source of funding | Authors declared that they do not have any conflicts of interest; no funding available. |
Analysis
Follow-up issues: varied across studies.
Study design issues: Comprehensive searches were done; studies were selected by 2 reviewers and any disagreements were resolved by a third reviewer; the risk of bias in each study was assessed by using the criteria for evaluating design-related deviations in Review Manager 5.3. The risk of bias was high for blinding of participants and personnel in all studies. Outcomes assessed were risk of TLF, stent thrombosis and cardiac death. Meta-analysis was done to assess differences in clinical efficacy between BRS and DES.
Studies were conducted in different countries, published between 2010-2018, with largely small sample sizes. Most of the studies assessed 'Absorb BRS' device. There is little evidence of publication bias.
Study population issues: significant differences were found in patient characteristics between BRS group and DES group.
There is some overlap of primary studies between the systematic reviews and meta-analyses and HTA1-4.
Key efficacy findings
Number of patients analysed: 3573 BRS versus 2810 DES
Pooled analysis of 10 studies showed statistically significant differences in TLF between BRS and DES. TLF of the BRS group was significantly higher than that of DES group with no heterogeneity among studies (OR = 1.46, 95% CI 1.20 to 1.79, p = 0.0002; p heterogeneity = 0.68, I2 = 0%).
Key safety findings
Pooled analysis of 10 studies indicated that the cardiac death in BRS was significantly higher than that of DES group with no heterogeneity among studies (OR = 2.19, 95% CI 1.17 to 4.07, p = 0.01; p heterogeneity = 0.93, I2 = 0%).
Pooled analysis of 10 studies indicated that stent thrombosis in BRS group was significantly higher than that of DES group with no heterogeneity among studies (OR = 2.70, 95% CI 1.57 to 4.66, p = 0.0003; p heterogeneity = 1.00, I2 = 0%).
Study 3 Stone GW (2019)
Study type | Systematic review and meta-analysis |
|---|---|
Country | International group |
Search period | Search date up to 21 July 2019; databases searched: MEDLINE and the Cochrane database. |
Study population and number | n=4 studies of 3384 patients with non-complex CAD BRS (n=2161) versus DES (n=1223) |
Age and sex | Mean age 62.8±11 years, 72.5% male |
Study selection criteria | Inclusion criteria: RCTs of the ABSORB everolimus-eluting PLLA bioresorbable vascular scaffold (BRS) system (Abbott Vascular) compared with a metallic DES in which at least 5-year clinical follow-up has been reported. Exclusion criteria: observational or non-randomised study design, with less than 5 years of follow-up data, lack of interval data between 0 to 3 years and 3 to 5 years, use of non-ABSORB BRS, use of metallic DES with bioabsorbable polymers, editorials, letters, expert opinions, case reports/series, studies with duplicated data, and non-human studies. |
Technique | Patients were randomly assigned to BRS or metallic EES and the corresponding scaffold was implanted during PCI. |
Follow-up | 5 years |
Conflict of interest/source of funding | This study and the 4 trials included were all funded by Abbott Vascular. Authors reported receiving institutional research grants, personal fees, and speaker fees from Abbott Vascular and other companies. Authors also reported acting as consultants for Abbott Vascular and other companies, and 1 author is an employee of Abbott Vascular. One author reported past membership of an Abbott Vascular advisory board. |
Analysis
Follow up issues: A total of 5 patients (3 randomised to BRS and 2 randomised to EES) withdrew consent immediately after enrolment in ABSORB China trial and were de-registered. These patients are not included in the study population. Follow up after 5 years was 80% (401/501), 93.8% (375/400), 96.4% (458/480) and 86.7% (1742/2008) in the 4 studies included.
Study design issues: comprehensive searches were done and 2 reviewers abstracted data. The review protocol was developed in accordance with PRISMA (preferred reporting items for systematic reviews and meta-analyses) reporting guidelines, and the Cochrane risk of bias tool was used to assess all included studies. Three of the eligible studies were single blind and 1 was open label study. The primary outcomes of interest were TLF cardiac mortality, target vessel–MI, or ischemia-driven TLR and definite or probable device thrombosis. Individual patient data from the 4 trials were pooled, and summary-level meta-analysis was performed.
Study population issues: Diabetes was present in 30.2% (1020/3384) of patients.
There is some overlap of primary studies between the systematic reviews and meta-analyses and HTA1-4.
Key efficacy findings
Number of patients analysed: 3384
Clinical outcomes up to 3 years and between 3 years and 5 years
Clinical outcome | Patients with outcome up to 3 years | Patients with outcome at 3-5 years** | P-value for interaction | ||||
BRS % (n = 2161) | EES % (n = 1223) | HR (95% CI) | BRS % (n = 1984) | EES % (n = 1121) | HR (95% CI) | ||
TLF^ | 11.6 (245/2161) | 7.9 (95/1223) | 1.42 (1.12-1.80) | 4.3 (82/1984) | 4.5 (48/1121) | 0.92 (0.64-1.31) | 0.046 |
POCE* | 19.9 (422/2161) | 15.8 (190/1223) | 1.23 (1.04-1.46) | 9.4 (180/1984) | 9.3 (100/1121) | 0.97 (0.76-1.24) | 0.10 |
All-cause mortality | 2.6 (54/2161) | 3.0 (35/1223) | 0.84 (0.55-1.29) | 3.4 (65/1984) | 2.7 (29/1121) | 1.22 (0.79-1.90) | 0.23 |
Cardiac mortality | 1.1 (22/2161) | 1.1 (13/1223) | 0.94 (0.47-1.88) | 1.2 (22/1984) | 1.7 (18/1121) | 0.68 (0.36-1.26) | 0.48 |
Non-cardiac mortality | 1.5 (32/2161) | 1.9 (22/1223) | 0.79 (0.46-1.35) | 2.3 (43/1984) | 1.0 (11/1121) | 2.11 (1.09-4.10) | 0.02 |
All MI | 9.0 (190/2161) | 5.5 (66/1223) | 1.56 (1.18-2.06) | 2.0 (38/1984) | 2.6 (28/1121) | 0.71 (0.44-1.16) | 0.004 |
TV-MI | 7.6 (161/2161) | 4.1 (49/1223) | 1.76 (1.28-2.43) | 1.4 (27/1984) | 1.4 (15/1121) | 0.96 (0.51-1.81) | 0.05 |
Non–TV-MI | 1.9 (39/2161) | 1.8 (21/1223) | 1.01 (0.59-1.73) | 0.7 (12/1984) | 1.3 (14/1121) | 0.44 (0.20-0.95) | 0.08 |
All revascularisation | 14.3 (299/2161) | 11.6 (138/1223) | 1.20 (0.98-1.47) | 5.7 (108/1984) | 6.3 (67/1121) | 0.86 (0.63-1.17) | 0.08 |
ID-TLR | 6.6 (137/2161) | 4.3 (51/1223) | 1.48 (1.07-2.04) | 2.3 (43/1984) | 1.8 (19/1121) | 1.20 (0.70-2.06) | 0.52 |
* POCE comprised of all-cause mortality, all MI, or all revascularisations.
** The 3-year to 5-year landmark period includes all randomised patients at 3 years except those who died before 3 years. Thus, there may be some patients with a non-fatal event within 3 years who have a second event between 3 years and 5 years.
^ TFL rate was defined as the composite of cardiac death, target vessel MI and ischaemia-driven TLR.
The increased risks of TLF, POCE, all MI, TV-MI, and ID-TLR present with BRS compared with EES between 0 and 3 years were not evident between 3 and 5 years. Non-cardiac mortality was increased in BRS-treated patients between 3 and 5 years.
Clinical outcome | Patients with outcome up to 5 years | |||
BRS % (n = 2161) | EES % (n = 1223) | HR (95% CI) | P value | |
TLF | 14.9 (308/2161) | 11.6 (135/1223) | 1.26 (1.03-1.54) | 0.03 |
POCE | 26.4 (550/2161) | 22.7 (267/1223) | 1.15 (0.99-1.33) | 0.07 |
All-cause mortality | 5.9 (119/2161) | 5.6 (64/1223) | 1.02 (0.75-1.38) | 0.92 |
Cardiac | 2.2 (44/2161) | 2.8 (31/1223) | 0.79 (0.50-1.25) | 0.31 |
Noncardiac | 3.8 (75/2161) | 2.9 (33/1223) | 1.23 (0.81-1.85) | 0.33 |
All MI | 10.7 (221/2161) | 7.9 (92/1223) | 1.30 (1.02-1.66) | 0.03 |
TV-MI | 8.8 (184/2161) | 5.5 (64/1223) | 1.55 (1.16-2.06) | 0.003 |
Non-TV-MI | 2.5 (51/2161) | 3.1 (35/1223) | 0.78 (0.51-1.20) | 0.26 |
All revascularisation | 18.4 (378/2161) | 16.3 (189/1223) | 1.10 (0.92-1.31) | 0.28 |
ID-TLR | 8.4 (172/2161) | 5.8 (67/1223) | 1.41 (1.06-1.87) | 0.02 |
ID-TVR | 13.1 (268/2161) | 19.8 (112/1223) | 1.32 (1.06-1.65) | 0.01 |
Key safety findings
Device thrombosis outcomes up to 3 years and between 3 years and 5 years
Clinical outcome | Patients with outcome up to 3 years | Patients with outcome at 3-5 years | P-value for interaction | ||||
BRS % (n = 2161) | EES % (n = 1223) | HR (95% CI) | BRS % (n = 1984) | EES % (n = 1121) | HR (95% CI) | ||
Device thrombosis, definite/probable | 2.4 (51/2161) | 0.6 (7/1223) | 3.86 (1.75-8.50) | 0.1 (2/1984) | 0.3 (3/1121) | 0.44 (0.07-2.70) | 0.03 |
Clinical outcome | Patients with outcome up to 5 years | |||
BRS % (n = 2161) | EES % (n = 1223) | HR (95% CI) | P value | |
Device thrombosis, definite/probable | 2.5 (53/2161) | 0.8 (10/1223) | 2.87 (1.46-5.65) | 0.002 |
Definite | 2.3 (48/2161) | 0.7 (8/1223) | 3.14 (1.48-6.64) | 0.003 |
Probable | 0.2 (5/2161) | 0.2 (2/1223) | 1.73 (0.33-9.09) | 0.52 |
Study 4 Kang SH (2018)
Study type | Systematic review and network meta-analysis |
|---|---|
Country | Republic of Korea |
Search details | Search period: inception to October 2017; databases searched: PubMed, Embase, Cochrane Central Register of Controlled Trials, and relevant websites. In addition, manual review of reference lists of included articles, recent reviews, editorials, and meta-analyses were also examined. |
Study population and number | n= 91 RCTs with 105,842 patients having PCI (comparing 2 or more coronary metallic stents or biodegradable scaffolds). |
Age | Median 66 years (range 30 to 88); 23 to 89% male |
Patient selection criteria | Inclusion criteria: studies comparing 2 or more coronary metallic stents or biodegradable scaffolds, reporting outcomes at more than 2 years with no restrictions on study period, sample size, publication status, patient or lesion criteria. Exclusion criteria: studies with follow-up less than 2 years, comparison of stents within the same category, no specification of stent types in study protocol, duplicate studies and publications in a language other than English. |
Technique | PCI using Absorb BRS, contemporary DES and bare metal stents (BMS). 12 stents were compared:
|
Follow-up | mean follow-up of 3.7 years (range 2 to 10 years) |
Conflict of interest/source of funding | authors have no conflicts of interest to declare. |
Analysis
Follow-up issues: follow-up varied across studies and was limited in BRS studies.
Study design issues: study registered on the PROSPERO database of systematic reviews. Comprehensive searches were done; studies were selected and data extracted by 2 reviewers and any disagreements were resolved by consensus. Direct and indirect evidence from multiple trials were combined and multiple treatment comparison network meta-analysis (using hierarchical Bayesian random effects meta-analysis models) was performed to give a comprehensive estimate. Also, pairwise meta-analyses was done for trials comparing BRS with cobalt-chromium everolimus-eluting stents (CoCr-EES) to provide better understanding of stent thrombosis risks according to follow-up period.
Studies had limited sample size and comparisons were available for certain type of stents (BP-EES, H-SES, dual SES, PtCr-EES, BRS; 7 trials tested the Absorb BRS, 6 with CoCr-EES, and 1 with PtCr-EES and BP-BES). There were 7 trials with a 3-arm design and 1 trial with a 4-arm design.
Key safety endpoint was the long-term risk of definite or probable stent/ScT defined according to the ARC criteria. Thrombosis rates were classified as early (≤30 days), late (31 days – 1 year), and very late (>1 year) according to the time of onset after the index procedure. The key secondary endpoint was definite stent/ScT defined according to the ARC criteria. Secondary endpoints of network meta-analysis included all-cause death, cardiac death, and MI, TVR and TLR. Secondary endpoints of frequentist conventional meta-analysis were TLF, cardiac death, target vessel MI, and ischaemia-driven or clinically driven TLR.
There was little evidence of publication bias. Most of the evidence was from direct comparison of BRS with CoCr-EES. Indirect evidence from network meta-analysis was weak.
BRS trials had stringent inclusion and exclusion criteria. The ABSORB II (n=501), ABSORB III (n=2,008), ABSORB Japan (n=398), and ABSORB China (n=475) trials enrolled stable or unstable angina patients, and excluded clinically or angiographically high-risk patients. ABSORB-STEMI TROFI II (n=192) exclusively enrolled patients with ST-segment elevation MI, and the EVERBIO II (n=238) and AIDA (n=1,845) trials had an "all-comers" design.
Study population issues: trials included had patients with different characteristics and medication protocols.
There is some overlap of primary studies between the systematic reviews and meta-analyses and HTA1-4.
Key efficacy findings
Number of patients analysed: n=99,112 (84 trials)
TLF (pairwise meta-analysis)
Pooled analysis of 6 RCTs, in patients with stable or unstable angina (4 studies), STEMI (1 study) or with all types of CHD (1 study) showed that TLF rates were not significantly different between the BRS group (n=3,179) and CoCr EES group (n=2,239) at 1 year (OR 1.26, 95% CI 0.99 to 1.61, p=0.059, I2=0%), but was significantly higher with BRS than CoCr-EES when the follow-up was extended to over than 1 year (OR 1.39, 95% CI 1.15 to 1.67, p<0.001, I2=0%).
Study | BVS | CoCr-EES | OR (95% CI) | P value, I2 | ||
Events | Total | Events | Total | |||
TLF (≤ 1 year) | ||||||
Absorb II | 16 | 335 | 5 | 166 | 1.62 (0.58 to 4.49) | |
Absorb Japan | 11 | 265 | 5 | 133 | 1.11 (0.38 to 3.26) | |
Absorb China | 8 | 238 | 10 | 237 | 0.79 (0.31 to 2.04) | |
Absorb Stemi Trofi II | 1 | 95 | 0 | 96 | 3.06 (0.12 to 76.2) | |
Absorb III | 102 | 1322 | 41 | 686 | 1.32 (0.90 to 1.91) | |
AIDA | 60 | 924 | 48 | 921 | 1.26 (0.85 to 1.87) | |
Overall (fixed effects model) | 198 | 3179 | 109 | 2239 | 1.26 (0.99 to 1.61) | 0.059, I2=0% |
Random effects model | 1.26 (0.99 to 1.61) | 0.063 | ||||
TLF (> 1 year) | ||||||
Absorb II | 37 | 335 | 9 | 166 | 2.17 (1.02 to 4.60) | |
Absorb Japan | 23 | 265 | 7 | 133 | 1.71 (0.71 to 4.10) | |
Absorb China | 13 | 238 | 11 | 237 | 1.91 (0.52 to 2.71) | |
Absorb Stemi Trofi II | 3 | 95 | 3 | 96 | 1.01 (0.20 to 5.14) | |
Absorb III | 229 | 1322 | 86 | 686 | 1.46 (1.12 to 1.91) | |
AIDA | 91 | 924 | 78 | 921 | 1.18 (0.86 to 1.62) | |
Overall (fixed effects model) | 396 | 3179 | 194 | 2239 | 1.39 (1.15 to 1.67) | <0.001,I2=0% |
Random effects model | 1.38 (1.15 to 1.66) | <0.001 | ||||
Pooled analysis showed that TLR did not differ significantly at 1 year (OR 1.28, 95% CI 0.91 to 1.80, p=0.150) between the BRS and CoCr EES groups and but showed a statistically significant difference at long-term follow-up (OR 1.46, 95% CI 1.12 to 1.85, p=0.004) with BRS compared to CoCr EES group.
Study | BRS | CoCr-EES | OR (95% CI) | P value, I2 | ||
Events | Total | Events | Total | |||
TLR (≤ 1 year) | ||||||
Absorb II | 4 | 335 | 3 | 166 | 0.66 (0.15 to 2.97) | |
Absorb Japan | 7 | 265 | 3 | 133 | 1.18 (0.30 to 4.62) | |
Absorb China | 6 | 238 | 5 | 237 | 1.20 (0.36 to 3.99) | |
Absorb Stemi Trofi II | 1 | 95 | 0 | 96 | 3.06 (0.12 to 76.2) | |
Absorb III | 40 | 1322 | 17 | 686 | 1.23 (0.69 to 2.18) | |
AIDA | 38 | 924 | 27 | 921 | 1.42 (0.86 to 2.35) | |
Overall (fixed effects model) | 96 | 3179 | 55 | 2239 | 1.28 (0.91 to 1.80) | 0.150, I2=0% |
Random effects model | 1.28 (0.91 to 1.79) | 0.155 | ||||
TLR (> 1 year) | ||||||
Absorb II | 22 | 335 | 3 | 166 | 3.82 (1.13 to 12.9) | |
Absorb Japan | 18 | 265 | 5 | 133 | 1.87 (0.68 to 5.14) | |
Absorb China | 10 | 238 | 6 | 237 | 1.69 (0.60 to 4.72) | |
Absorb Stemi Trofi II | 2 | 95 | 1 | 96 | 2.04 (0.18 to 22.9) | |
Absorb III | 92 | 1322 | 39 | 686 | 1.24 (0.84 to 1.83) | |
AIDA | 60 | 924 | 45 | 921 | 1.35 (0.91 to 2.01) | |
Overall (fixed effects model) | 204 | 3179 | 99 | 2239 | 1.46 (1.12 to 1.85) | 0.004, I2=0% |
Random effects model | 1.43 (1.10 to 1.82) | 0.007 | ||||
A network meta-analysis of 91 RCTs showed similar performance with BRS and other DES, and statistically significantly better than BMS in terms of TVR and TLR.
Key safety findings
Pairwise meta-analysis: pooled results of trials directly comparing BVS versus CoCr-EES, n=6 RCTs)
Pooled results of 6 studies showed that the risk of (definite or probable) ScT with BRS was high compared to CoCr-EES (contemporary second-generation DES) across all time points (early [OR 2.01, 95% CI 1.05 to 3.85, p=0.034, I2=0%]; late [OR 3.87, 95% CI 1.15 to 13.0, p=0.029, I2=1.3%] and very late [OR 5.09, 95% CI 1.94 to 13.3, p=<0.001, I2=0%]).
Study | BRS | CoCr-EES | OR (95% CI) | P value, I2 | ||
Events | Total | Events | Total | |||
Early stent thrombosis (≤ 30 days) | ||||||
Absorb II | 2 | 335 | 0 | 166 | 2.50 (0.12 to 52.3) | |
Absorb Japan | 3 | 265 | 1 | 133 | 1.52 (0.16 to 14.7) | |
Absorb China | 1 | 238 | 0 | 237 | 3.00 (0.12 to 74.0) | |
Absorb Stemi Trofi II | 1 | 95 | 0 | 96 | 3.06 (0.12 to 76.2) | |
Absorb III | 14 | 1322 | 5 | 686 | 1.46 (0.52 to 4.06) | |
AIDA | 13 | 924 | 5 | 921 | 2.61 (0.93 to 7.36) | |
Overall (fixed effects model) | 34 | 3179 | 11 | 2239 | 2.01 (1.05 to 3.85) | 0.034, I2=0% |
Random effects model | 2.01 (1.05 to 3.82) | 0.036 | ||||
Late stent thrombosis (1 year) | ||||||
Absorb II | 1 | 335 | 0 | 166 | 1.49 (0.06 to 36.9) | |
Absorb Japan | 1 | 265 | 1 | 133 | 0.50 (0.03 to 8.06) | |
Absorb China | 0 | 238 | 0 | 237 | ||
Absorb Stemi Trofi II | 0 | 95 | 0 | 96 | ||
Absorb III | 6 | 1322 | 0 | 686 | 6.78 (0.38 to 121) | |
AIDA | 8 | 924 | 1 | 921 | 8.03 (1.00 to 64.4) | |
Overall (fixed effects model) | 16 | 3179 | 2 | 2239 | 3.87 (1.15 to 13.0) | 0.029, I2= 1.3% |
Random effects model | 3.13 (0.93 to 11.8) | 0.092 | ||||
Very late stent thrombosis (≥1 year) | ||||||
Absorb II | 6 | 335 | 0 | 166 | 6.57 (0.37 to 117) | |
Absorb Japan | 5 | 265 | 0 | 133 | 5.64 (0.31 to 103) | |
Absorb China | 1 | 238 | 0 | 237 | 3.00 (0.12 to 74.0) | |
Absorb Stemi Trofi II | 1 | 95 | 1 | 96 | 1.01 (0.06 to 16.4) | |
Absorb III | 10 | 1322 | 0 | 686 | 11.0 (0.64 to 188) | |
AIDA | 10 | 924 | 2 | 921 | 5.03 (1.10 to 23.0) | |
Overall (fixed effects model) | 33 | 3179 | 3 | 2239 | 5.09 (1.94 to 13.3) | <0.001, I2=0% |
Random effects model | 4.50 (1.67 to 12.1) | 0.003 | ||||
Definite or probable stent thrombosis (comparison between different stents: network meta-analysis -ORs and credible intervals for each pair of comparisons were derived from the Bayesian random effects model).
Network meta-analysis showed that patients treated with the Absorb BRS had a significantly higher risk of long-term (definite or probable) ScT compared to those treated with metallic DES (R-ZES, E-ZES, BP-BES, dual DES, CoCr-EES, H-SES, and BP-EES). The risk of very late definite or probable (>1-year) stent thrombosis was significantly higher for BS than any other comparators except PtCr-EES and BP-EES . BMS showed a lower very late ST risk than SES and PES as well as BRS.
Pooled analysis of 6 studies showed that the risk of cardiac death was similar both at 1 year (OR 1.13, 95% CI 0.57 to 2.24, p=0.717) and at the extended follow-up to the long-term (OR 0.86, 95% CI 0.55 to 1.33, p=0.498) between the BRS and CoCr EES groups.
BRS | CoCr-EES | OR (95% CI) | P value, I2 | ||||
Events | Total | Events | Total | ||||
Cardiac death (≤ 1 year) | |||||||
Absorb II | 0 | 335 | 0 | 166 | - | ||
Absorb Japan | 0 | 265 | 0 | 133 | - | ||
Absorb China | 0 | 238 | 3 | 237 | 0.14 (0.01 to 2.73) | ||
Absorb Stemi Trofi II | 0 | 95 | 0 | 96 | - | ||
Absorb III | 8 | 1322 | 1 | 686 | 4.17 (0.52 to 33.4) | ||
AIDA | 12 | 924 | 11 | 921 | 1.09 (0.48 to 2.48) | ||
20 | 3179 | 15 | 2239 | 1.13 (0.57 to 2.24) | 0.717 | ||
Random effects model | 1.12 (0.30 to 4.26) | 0.866 | |||||
Cardiac death (> 1 year) | |||||||
Absorb II | 5 | 335 | 4 | 166 | 0.61 (0.16 to 2.32) | ||
Absorb Japan | 1 | 265 | 0 | 133 | 1.51 (0.06 to 37.4) | ||
Absorb China | 1 | 238 | 3 | 237 | 0.33 (0.03 to 3.19) | ||
Absorb Stemi Trofi II | 1 | 95 | 0 | 96 | 3.06 (0.12 to 76.2) | ||
Absorb III | 18 | 1322 | 8 | 686 | 1.17 (0.51 to 2.70) | ||
AIDA | 18 | 924 | 23 | 921 | 0.78 (0.42 to 1.45) | ||
Overall (fixed effects model) | 44 | 3179 | 38 | 2239 | 0.86 (0.55 to 1.33) | 0.498 | |
Random effects model | 0.86 (0.55 to 1.34) | 0.496 | |||||
Target vessel MI (pairwise meta-analysis)
The pooled risk of target vessel MI (from 6 studies) was significantly higher with BRS at both 1 year follow-up (OR 1.59, 95% CI 1.16 to 2.18, p=0.004) and in the long term (OR 1.67, 95% CI 1.28 to 2.18, p<0.001) compared to CoCr EES group.
Study | BRS | CoCr-EES | OR (95% CI) | P value, I2 | ||
Events | Total | Events | Total | |||
Target vessel MI (≤ 1 year) | ||||||
Absorb II | 15 | 335 | 2 | 166 | 3.84 (0.87 to 17.0) | |
Absorb Japan | 9 | 265 | 3 | 133 | 1.52 (0.41 to 5.72) | |
Absorb China | 4 | 238 | 2 | 237 | 2.01 (0.36 to 11.1) | |
Absorb Stemi Trofi II | 1 | 95 | 0 | 96 | 3.06 (0.12 to 76.2) | |
Absorb III | 79 | 1322 | 31 | 686 | 1.34 (0.88 to 2.06) | |
AIDA | 34 | 924 | 20 | 921 | 1.72 (0.98 to 3.01) | |
Overall (fixed effects model) | 475 | 3179 | 58 | 2239 | 1.59 (1.16 to 2.18) | 0.004, I2=0% |
Random effects model | 1.57 (1.14 to 2.14) | 0.005 | ||||
Target vessel MI (> 1 year) | ||||||
Absorb II | 24 | 335 | 3 | 166 | 4.19 (1.24 to 14.1) | |
Absorb Japan | 14 | 265 | 4 | 133 | 1.80 (0.58 to 5.58) | |
Absorb China | 6 | 238 | 2 | 237 | 3.04 (0.61 to 15.2) | |
Absorb Stemi Trofi II | 2 | 95 | 3 | 96 | 0.67 (0.11 to 4.08) | |
Absorb III | 112 | 1322 | 40 | 686 | 1.49 (1.03 to 2.17) | |
AIDA | 48 | 924 | 30 | 921 | 1.63 (1.02 to 2.59) | |
Overall (fixed effects model) | 206 | 3179 | 82 | 2239 | 1.67 (1.28 to 2.18) | <0.001,I2=0% |
Random effects model | 1.64 (1.25 to 2.14) | <0.001 | ||||
Network meta-analyses for all-cause death, cardiac death, MI, TVR, and TLR
Network meta-analysis showed that BRS was associated with an increased risk of all cause cardiac death, cardiac death, MI compared to DES (SES, BP-BES, CoCr-EES, R-ZES, E-ZES, dual DES, PtCr-EES, and H-SES). BRS showed similar performance as compared with other DES, and significantly better than BMS in terms of TVR and TLR.
Study 5 Baumbach A (2018)
Study type | Prospective case series (ABSORB UK Registry) |
|---|---|
Country | United Kingdom (24 centres) |
Recruitment period | 2014-2015 |
Study population and number | n=1,005 patients with de novo coronary lesions Target vessel: 54% LAD, 27% RCA, 18% LCx. Mean RVD 3.16±0.46mm, mean lesion length 23.3±13.3 mm. |
Age and sex | Mean age 52±11 years, 75% male |
Patient selection criteria | Inclusion criteria: Adults aged over 18 years with previously untreated de novo coronary lesions (prior treatment of lesions in a non-target vessel was permitted), willing to have all follow-up visits and data collection. Exclusion criteria: Inability to give informed consent or comply with protocol. |
Technique | ABSORB everolimus-eluting PLLA bioresorbable vascular scaffold (BRS) system (Abbott Vascular) was implanted into patients. The technical recommendation was for appropriate lesion preparation with low residual stenosis prior to implantation of the scaffold, sizing according to angiographic vessel size with avoidance of under-sizing, and routine post-dilatation with high-pressure non-compliant balloons. The use of online QCA was explicitly encouraged in order to size the scaffold appropriately. The vessel size range was governed by the available scaffold sizes and the limited capacity for further expansion after implantation. Adjunctive imaging with IVUS or OCT was not specifically recommended but encouraged for complex lesions. Selection, dosing, and duration of antiplatelet therapy was left to individual operators' discretion, but the majority of centres opted for a prescribed DAPT duration of 12 months. |
Follow-up | 12 months |
Conflict of interest/source of funding | Study was supported by institutional grant from Abbott Vascular. Several authors reported receiving institutional research grants, research support and speaker fees from Abbott Vascular, and 1 author is a consultant for Abbott Vascular. |
Analysis
Follow-up issues: High follow-up (98.7% after 12 months), 13 patients were lost to follow-up.
Study design issues: Prospective observational post-market registry analysis. Recommendations for patient selection and implantation technique were not binding. Primary endpoint of the study was TLF at 12 months and primary patient-related outcome was MACE. An independent clinical events committee, consisting of experienced and unbiased cardiologists, adjudicated all serious adverse events and protocol endpoints.
Study population issues: 28.9% smokers, 49.9% hypertension, 56.5% dyslipidaemia, 17.4% diabetes. 24.3% prior MI, 20.9% prior PCI, 1.3% prior CABG, 31.9% NSTEMI, 13.8% STEMI.
Key efficacy findings
Number of patients analysed: 1,005
Device success (defined as successful implantation of 1 or more scaffolds with a final in-scaffold residual diameter stenosis of <50%, without BVS device deficiency): 98.7%
Procedure success (defined as successful implantation of 1 or more BVS with a final in-scaffold diameter stenosis of <50%, without TVF within 3 days of the index procedure): 97.3%
Clinical outcome | In-hospital % (n=1,005) | 30 days % (n=992) | 12 months % (n=992) | |
|---|---|---|---|---|
TLF | 0.9 (9/1,005) | 1.2 (12/992) | 3.2 (32/992) | |
MACE* | 0.9 (9/1,005) | 1.2 (12/992) | 3.4 (34/992) | |
TVF | 1.0 (10/1,005) | 1.4 (14/992) | 4.3 (43/992) | |
All death | 0 (0/1,005) | 0.1 (1/992) | 0.6 (6/992) | |
Cardiac death | 0 (0/1,005) | 0.1 (1/992) | 0.3 (3/992) | |
MI outcomes | ||||
MI (protocol definition) | All MI | 0.8 (8/1,005) | 1.0 (10/992) | 2.1 (21/992) |
Q-wave MI | 0.5 (5/1,005) | 0.7 (7/992) | 0.8 (8/992) | |
Non-Q-wave MI | 0.3 (3/1,005) | 0.3 (3/992) | 2.1 (21/992) | |
MI (third universal definition) | Type 1 | 0.2 (2/1,005) | 0.4 (4/992) | 1.5 (15/992) |
Type 2 | 0.2 (2/1,005) | 0.2 (2/992) | 0.4 (4/992) | |
Type 3 | 0 (0/1,005) | 0 (0/992) | 0.1 (1/992) | |
Type 4a | 1.5 (15/1,005) | 1.5 (15/992) | 1.7 (17/992) | |
Type 4b | 0.6 (6/1,005) | 0.8 (8/992) | 1.3 (13/992) | |
Type 5 | 0 (0/1,005) | 0 (0/992) | 0 (0/992) | |
Revascularisation outcomes | ||||
TLR | All | 0.6 (6/1,005) | 1.0 (10/992) | 2.5 (25/992) |
ID-TLR | 0.6 (6/1,005) | 0.9 (9/992) | 2.3 (23/992) | |
CABG | 0 (0/1,005) | 0 (0/992) | 0.1 (1/992) | |
PCI | 0.6 (6/1,005) | 0.9 (9/992) | 2.2 (22/992) | |
TVR | All | 0.8 (8/1,005) | 1.3 (13/992) | 3.8 (38/992) |
ID-TVR | 0.8 (8/1,005) | 1.2 (12/992) | 3.6 (36/992) | |
CABG | 0 (0/992) | 0 (0/992) | 0.4 (4/992) | |
PCI | 0.8 (8/1,005) | 1.2 (12/992) | 3.2 (32/992) | |
All revascularisation | PCI | 1.9% (19/1,005) | 3.8 (38/992) | 14.3 (143/992) |
CABG | 0 (0/1,005) | 0 (0/992) | 0.6 (6/992) | |
*MACE rate was defined as cardiac death, all MI and ischaemia-driven TLR
^TVF including cardiac death, all MI and ischaemia-driven TVR
Key safety findings
Clinical outcome | In-hospital % (n=1,005) | 30 days % (n=992) | 12 months % (n=992) |
|---|---|---|---|
Stent thrombosis (definite/probable)* | 0.2 (2/1,005) | 0.9 (9/992) | 1.7 (17/992) |
*Core lab adjudicated
At 12 months, the overall definite stent thrombosis rate was 1.4% (14/992); (acute 0.1%, subacute 0.7%, late 0.6%).
In all definite stent thrombosis cases, average vessel diameter was 2.62±0.41mm. In 5 of these cases, the core lab identified the target vessel to be less than 2.3 mm in diameter (range: 1.8-2.25 mm) by QCA, and in
2 cases there was a marked size mismatch (scaffold undersized >0.2 mm).
In multivariable analysis, only the use of the smallest scaffold size of 2.5 mm remained significantly correlated to stent thrombosis (OR 3.27, 95% CI: 1.28-8.37; p=0.0136).
Study 6 Cakal S (2021)
Study type | Retrospective case series |
|---|---|
Country | Turkey |
Recruitment period | 2014-2016 |
Study population and number | n=110 patients with CAD. Clinical diagnosis: stable angina (84%), ACS (16%) and heart failure (11%). Vessels diseased per patient 1.6. mean grade of stenosis was 80%, lesions RVD 3.13 mm; median length of the scaffold per patient was 28 mm (IQR: 17mm). |
Age and sex | Mean age 60±11.3 years, 80% male |
Patient selection criteria | Inclusion criteria: patients >18 years with myocardial ischemia, stable CAD and ACS, with a RVD ≥2.50 mm, stenosis of >50% in the native coronary arteries were included. Exclusion criteria: left main coronary artery lesion, a saphenous vein graft lesion, or the presence of a lesion requiring stents >4.0 mm or 2.5 mm. |
Technique | 150 Absorb BRS were implanted using pre-dilation (in all), proper sizing, and post-dilation (in 95%). Lesions treated were in the anterior descending coronary artery (51%,n=77), right coronary (30%, n=45) and circumflex (19%, n=28) arteries. Mean number of Absorb BRS implanted per patient was 1.4±0.6. 51% of the patients had at least 2 scaffolds implanted. Mean number of BRS per lesion, 1.18±0.4. Long-segment lesions (>28 mm) that could not be covered with a single BRS needed overlapping stents. 2 BRSs were overlapped in 19 patients/lesions, and an overlapping of BRS and a DES was performed in 30 patients (31 lesions). The implanted stent length did not differ significantly between the DES-BRS group (55.2 mm) and the BRS-BRS group (49.3 mm). Decision to implant an Absorb BRS was left to the operator. Routine angiography and imaging modalities during follow-up were not performed. All patients were anticoagulated, treated with DAPT for at least 12 months after the procedure. Quantitative coronary angiography (QCA) was performed in all. |
Follow-up | median 53 months (range: 46–59 months) |
Conflict of interest/source of funding | None; no funding available. |
Analysis
Follow-up issues: long term follow-up.
Study design issues: small sample from a single centre; data were collected retrospectively from medical records and through hospital visits and telephone consultations. The overlap patients had more complex lesion morphologies. The rate of MACE was studied using QCA.
Study population issues: 38% patients had diabetes mellitus; hypertension, hyperlipidaemia, and a smoking history were reported in 62%, 65%, and 42%.
Key efficacy findings
Number of patients analysed: 110 BRS and 40 overlapping (2 BRSs in 19 patients/lesions, and BRS and DES in 30 patients (31 lesions)
The device success was 99% (149/150) and the procedural success (defined as angiographic success in the absence of in-hospital death, MI, or revascularisation) was 98% (108/110).
Clinical outcomes
Total (n=110) | DES-BRS (n=30) | BRS -BRS | p value | |
1 year % (n) | ||||
All-cause death | 1.8 (2) | 0 | 5.2 (1) | NA |
Cardiac death | 1.8 (2) | 0 | 5.2 (1) | NA |
TV-MI | 4.5 (5) | 3.3 (1) | 15.7 (3) | 1 |
Definite ScT | 2.7 (3) | 3.3 (1) | 5.2 (1) | NA |
TVR | 8.2 (9) | 10 (3) | 10.5 (2) | 0.95 |
TLR | 7.3 (8) | 6.7 (2) | 10.5 (2) | 0.64 |
MACE* | 10 (11) | 10 (3) | 15.7 (3) | 0.67 |
4 years % (n) | ||||
All-cause death | 4.5 (5) | 3.3 (1) | 5.2 (1) | NA |
Cardiac death | 2.7 (3) | 3.3 (1) | 5.2 (1) | NA |
TV-MI | 8.2 (9) | 13.3 (4) | 15.7 (3) | 0.81 |
Definite ScT | 5.5 (6) | 10 (3) | 10.5 (2) | 0.36 |
TVR | 18.2 (20) | 26.6 (8) | 21 (4) | 0.74 |
TLR | 18.2 (20) | 26.6 (8) | 21 (4) | 0.74 |
MACE | 5.5 (6) | 26.6 (8) | 16.7 (5) | 0.97 |
Complete follow-up % (n) | ||||
All-cause death | 4.5 (5) | 3.3 (1) | 5.2 (1) | NA |
Cardiac death | 2.7 (3) | 3.3 (1) | 5.2 (1) | NA |
TV-MI | 8.2 (9) | 13.3 (4) | 16.7 (3) | 0.81 |
Definite ScT^^^ | 5.5 (6) | 6.7 (2) | 5.2 (3) | 0.3 |
TVR^ | 21.8 (24) | 30 (9) | 21 (4) | 0.48 |
TLR^^ | 21.8 (24) | 30 (9) | 21 (4) | 0.48 |
MACE | 23.6 (26) | 30 (9) | 16.7 (5) | 0.78 |
*defined as a composite of cardiac death, target vessel MI, and clinically-driven TLR.
^defined as repeat PCI or coronary artery bypass graft in the target vessel.
^^defined as any revascularisation within 5 mm of the scaffold.
^^^according to ARC.
The 4-year Kaplan-Meier estimate of MACE was 20%
Cox regression analysis indicated that a small BRS diameter (2.5 mm) was a risk factor for the development of a MACE during follow-up (HR: 2.23; 95% CI: 0.97 to 2.23; p=0.05)
Key safety findings
Procedural complications
Slow-flow periprocedural MI (n=1)
Scaffold rupture (managed with prolonged balloon inflation) n=1
Study 7 Costa JR (2019)
Study type | Prospective case series (ABSORD EXTEND study- NCT01023789) |
|---|---|
Country | multicentre study outside USA |
Recruitment period | 2010-2013 |
Study population and number | n=812 patients with low to moderate complexity CAD. Clinical diagnosis: stable angina 461 (56.8%), unstable angina 215 (26.5%), non ST elevation MI 136 (16.7%) Multiple vessel disease in 17.5% (n=142); single target lesion in 92.4% (n=750) Target artery, n (%): LAD 395 (45.2%), LCX 228 (26.1%), RCA 250 (28.6%), LM 1 (0.1%). |
Age and sex | Average age 61 years, 74.3% male |
Patient selection criteria | Inclusion criteria: target arteries with a maximum lesion length 28 mm, lesion RVD 2.0 – 3.8 mm, diameter stenosis ≥50% and <100%, 2 de novo native coronary artery lesions, each located in a different major epicardial vessel. Exclusion criteria: recent MI (less than 72 hours before the index procedure) and target lesions located in the left main or within an arterial or saphenous vein graft. |
Technique | Absorb BVS implanted using a pre-dilation (in all), proper sizing, and post-dilation (in 68.8%). Single lesion was treated in 92.4%, the target vessel was LAD in 45.2%. Lesion stenosis, 58.7 ± 10.6%; overlapping was required in 10.5% of the procedures. Mean RVD and lesion length were 2.64 ± 0.39mm and 12.5 ± 5.3mm, respectively. |
Follow-up | 3 years |
Conflict of interest/source of funding | Study was funded by the manufacturer. |
Analysis
Follow-up issues: complete follow-up.
Study design issues: prospective study with large sample from 56 centres; outcomes assessed were 3 year MACE rates, TVF and ScT.
Study population issues: 26.5% (n=215) patients had diabetes mellitus; 71.4% (580) had hypertension, 71.9% (584) had hypercholesterolemia; prior stenting in 27.6% (n=224).
Key efficacy findings
Number of patients analysed: 812
Procedure outcomes
Device success, % (n) | 98.9 (861/874 lesions) |
Procedure success, n (%) | 97 (785/874 lesions) |
Adequate scaffold implantation (pre-dilatation, sizing, post-dilatation), % (n) | 14.2 (115/874) |
Need for "bail out" scaffold/stent (use of additional, unplanned device to treat a complication related to the implant of the BVS) occurred in 4.2% of the procedures, 2.2% were performed with the implant of an additional BRS.
Clinical outcomes
30 days | 1 year | 3 years | |
MACE, % | 2.6 | 5.1 | 9.2 |
TVF, % | 2.6 | 5.5 | 10.6 |
Ischemia driven TLR | 0 | 1.4 | 3.1 |
Use of DAPT | 98.8 | 79 | 40.1 |
Most of the in-hospital MACE was also driven by peri procedure MI.
Independent predictors of MACE were hypertension (OR 2.26, 95% CI: 1.18 – 4.32, p=0.01) and use of "bail out" stent (OR 3.32, 95% CI:1.37, 8.05, p= 0.008).
Clinical outcomes
30 days | 1 year | 3 years | |
ScT (definite/probable), % | 0.6 | 1.0 | 2.2^ |
Cardiac death, % | 0.2 | 0.7 | 2.1 |
MI, % | 2.3 | 3.0 | 4.0 |
Q-wave MI % | 0.6 | 0.7 | 1.0 |
Non Q-wave MI | 1.7 | 2.3 | 3.0 |
^of the 8 cases of very late ScT, 7 occurred among patients who did not fulfill the PSP criteria.
Study 8 Wiebe J (2021)
Study type | Case series (ISAR-ABSORB registry) |
|---|---|
Country | Germany (2 centres) |
Recruitment period | 2012-2014 |
Study population and number | n=419 symptomatic patients with de novo lesions having PCI with BRS lesions treated: n=527 (according to ACC/AHA lesion morphology 49% were complex and 13.1% were bifurcation lesions). Clinical diagnosis: CAD (n=256), unstable angina (n=48), non ST evaluation MI (n=80), ST evaluation MI (n=35). Baseline angiographic outcomes: RVD 2.89 mm, minimum lumen diameter 0.91 mm, stenosis 68.6%, lesion length 15.8%. |
Age and sex | Mean age 67 years, 77% male |
Patient selection criteria | Inclusion criteria: symptomatic patients with de novo lesions. |
Technique | PCI-implantation of everolimus-eluting BRS (Absorb, Abbott Vascular) at the discretion of the interventional cardiologist. Modification in implantation (post-dilatation) was done after early experience. Pre-dilation was done in 97.7% and post-dilation in 71.5% lesions. Peri-procedural unfractionated heparin or bivalirudin and a loading dose of aspirin and ADP receptor antagonist was administered in all patients. 95.5% patients were given aspirin indefinitely and all patients had an ADP receptor antagonist.14.1% were given oral anticoagulation therapy at the operator's discretion. Post intervention lumen diameter was 2.60 mm and diameter stenosis was 13.7%. Mean of 1.2±0.4 BRS per lesion with a mean length of 26.9 ±13.2 mm were implanted. 17.9% (75/419) patients had BRS overlap, of these 41 patients had for treatment of long lesions and 34 patients had because of dissection. |
Follow-up | Median 4.9 years |
Conflict of interest/source of funding | 3 authors received consulting or lecture fees and research grants from Biotronik and other companies. |
Analysis
Follow-up issues: . Routine angiographic follow-up was done at 6 to 8 months, further clinical telephone follow-up was done at 1 and 12 months and annually up to 5 years.
Study design issues: prospective non-randomised study with good sample size; the primary outcomes assessed were the composite of death, MI and TLR, and definite ScT according to ARC criteria. There is lack of data on long-term DAPT.
Study population issues: there were 39% patients with ACS, 31.5% (n=132) had diabetes mellitus, 86.2% had hypertension, 76.1% had hypercholesterolemia.
Key efficacy findings
Number of patients analysed: 419
Procedure outcomes
Procedural success | 96.8% |
Angiography results (at 6 – 8 months for 71% [374/527] of lesions) | |
In-stent late lumen loss | 0.27 ± 0.51 mm |
In-segment diameter stenosis | 27.7 ±16.1%. |
Binary restenosis | 8.0% |
Clinical outcomes
1 year (n=348) | 2 years (n=317) | 3 years (n=286) | 4 years (264) | 5 years (217) | |
14.0 | 20.0 | 26.5 | 29.6 | 33.1 | |
TLR, % | 1 year (n=351) | 2 years (n=322) | 3 years (n=289) | 4 years (266) | 5 years (225) |
9.9 | 14.4 | 17.2 | 18.8 | 20.3 |
In the multivariate analysis, the incidence of the primary composite endpoint (of death, MI and TLR) was significantly associated with higher age (HR 1.29; 95% CI, 1.04-1.58; p = 0.02), female sex (HR 0.54; 95%CI, 0.33-0.90; p = 0.02), the number of treated lesions (HR 1.40; 95%CI, 1.14-1.74; p < 0.01), and BRS overlap (HR 1.39; 95%CI, 1.01-1.91; p < 0.05). The only predictor of TLR was the number of lesions treated (HR 1.64; 95%CI, 1.22-2.21; p < 0.01).
Key safety findings
Clinical outcomes
All-cause death, % | 1 year (n=392) | 2 years (n=373) | 3 years (n=350) | 4 years (n=329) | 5 years (n=274) | |
3.6 | 5.6 | 9.5 | 11.9 | 14.0 | ||
Cardiac death, % | 2.2 | 2.9 | 5.1 | 5.9 | 7.5 | |
MI, % | 1 year (n=386) | 2 years (n=363) | 3 years (n=344) | 4 years (315) | 5 years (305) | |
3.6 | 4.9 | 5.4 | 5.9 | 6.2 | ||
Death or MI, % | 6.5 | 9.5 | 13.6 | 16.0 | 18.4 | |
Definite stent thrombosis^, % | 30 days (n=419) | 1 year (n=390) | 2 years (n=364) | 3 years (n=348) | 4 years (n=318) | 5 years (n=309) |
1.9^^ | 2.4 | 3.7 | 4.2 | 4.4 | 4.7 |
^^all patients were on DAPT except 1. ^None of the patients with late ScT (1-5 years) were on DAPT. OCT in 4 of these patients showed scaffold discontinuation with mal-apposed struts in 3 cases, of which 1 also had evidence of restenosis and a tissue bridge possibly related to chronic mal-apposition. In 1 patient an aneurysm in the BRS region was seen. Most definite ScT occurred within 2 years after BRS implantation.
Study 9 Sabaté M (2019)
Study type | Randomised controlled trial (NCT03234348) |
|---|---|
Country | Spain |
Recruitment period | 2017-2018 |
Study population and number | n= 150 ST-STEMI patients. mgBRS (n=74) versus DES (n=76) |
Age and sex | Mean age 59.0±10.4 years, 89.3% male |
Patient selection criteria | Inclusion criteria: patients >18 years with STEMI having primary PCI, at least 1 target lesion suitable for either MgBRS or SES implantation. Exclusion criteria: STEMI secondary to stent/ScT, target lesions with a RVDof <2.75 mm or >3.75 mm, and tortuous or calcified vessels that in the opinion of the investigators would result in suboptimal MgBRS implantation. |
Technique | Patients were randomised 1:1 to have either MgBRS (Magmaris, Biotronik AG) or SES (Orsiro, Biotronik AG) following successful lesion preparation by either manual thrombectomy or predilatation, with opening of the vessel, thrombolysis in MI ≥2 and residual stenosis <20%. SES implantation technique was left to the discretion of the operator. However, a dedicated implantation technique according to the guidelines provided in the BVS-STEMI STRATEGY study was implemented for MgBRS. In particular, predilatation was mandatory when residual stenosis was >30% and full expansion of the predilatation balloon was required to allow Mg-BRS implantation. Post dilatation was also mandatory in all patients randomised to Mg-BRS stent, by using a noncompliant balloon of up to 0.5 mm more in diameter than the scaffold implanted. Periprocedural anticoagulation and the use of glycoprotein IIb/IIIa were left to the discretion of the operator. Dual antiplatelet therapy, preferably ticagrelor (90 mg bid) or prasugrel (10 mg/day) was prescribed in both study groups for 1 year with aspirin (100 mg/day). |
Follow-up | 12 months |
Conflict of interest/source of funding | Study funded by the Spanish Heart Foundation. No authors disclosed links to Biotronik, but several authors report receiving speaker fees, personal fees and research grants from other companies. |
Analysis
Follow-up issues: Good follow-up; clinical outcomes were obtained in all patients at 12 months.
Study design issues: Device success was defined as implantation of the intended device with attainment of <30% residual stenosis of the target lesion and thrombolysis in MI ≥2. Procedural success was defined as device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/ScT. POCE is defined as combined (hierarchical) of all-cause death, any recurrent MI, or any revascularisation.
Revascularisation was considered ischemia-driven if associated with any of the following: non-invasive positive functional ischemia study (e.g., exercise testing or equivalent tests) or invasive positive functional ischemia study (e.g., fractional flow reserve or coronary flow reserve); ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥50% by on-line QCA; or diameter stenosis ≥70% by on-line QCA without either ischaemic symptoms or a positive functional study
Study population issues: 56% (84/150) current smokers, 16% (24/150) diabetes mellitus, 43.3% (65/150) hypertension, 58.0% (87/150) hypercholesterolemia, 14% (21/150) family history of CAD, 5.3% (8/150) previous MI, 3.3 % (5/150) previous PCI, 5.3% (8/150) COPD, 2% (3/150) cardiac arrest at presentation.
Key efficacy findings
Number of patients analysed: 150
Clinical events and outcomes at 1 year
SES % (n=76) | MgBRS (n=74) | % Difference (95% CI) | P value | |
Device success | 100 (76/76) | 98.6 (73/74) | 1.4 (-1.3, 4.0) | 0.493 |
Procedural success | 96.1 (73/76) | 95.9 (71/74) | 0.2 (-6.2, 6.4) | 1.000 |
POCE | 14.5 (11/76) | 23.0 (17/74) | -8.5 (-20.9, 3.9) | 0.182 |
DOCE | 6.6 (5/76) | 17.6 (13/74) | -11.0 (-21.3, -0.7) | 0.038 |
All-cause death | 1.3 (1/76) | 1.4 (1/74) | 0.1 (-3.7, 3.6) | 0.985 |
Cardiac death | 1.3 (1/76) | 1.4 (1/74) | 0.1 (-3.7, 3.6) | 0.985 |
MI | 3.9 (3/76) | 1.4 (1/74) | 2.5 (-2.5, 7.7) | 0.620 |
Related with device thrombosis | 2.6 (2/76) | 1.4 (1/74) | 1.2 (-3.2, 5.7) | 1.000 |
Spontaneous MI | 1.3 (1/76) | 0 (0/74) | 1.3 (-1.3, 3.9) | 1.000 |
TLR | 5.3 (4/76) | 16.2 (12/74) | -10.9 (-20.7, -1.2) | 0.030 |
TLR (ischaemia driven) | 5.3 (4/76) | 16.2 (12/74) | -10.9 (-20.7, -1.2) | 0.030 |
TVR | 7.9 (6/76) | 20.3 (15/74) | -12.4 (-23.4, -1.4) | 0.029 |
Non-TVR | 3.9 (3/76) | 2.7 (2/74) | 1.2 (-4.5, 7.0) | 1.000 |
Key safety findings
SES % (n=76) | MgBRS (n=74) | % Difference (95% CI) | P value | |
Definite device thrombosis at 1 year | 2.6 (2/76) | 1.4 (1/74) | 1.2 (-3.2, 5.7) | 1.000 |
Definite or probable device thrombosis at 1 year | 2.6 (2/76) | 1.4 (1/74) | 1.2 (-3.2, 5.7) | 1.000 |
The 1 case of definite device thrombosis in the MgBRS group occurred (0 minutes after implantation and
was resolved by thrombectomy and new balloon post dilatation. In the SES arm, this adverse event occurred
in 2 patients (1 acute and 1 subacute definite stent thrombosis).
Study 10 Haude M (2020)
Study type | Pooled case series (BIOSOLVE-II and BIOSOLVE III studies) |
|---|---|
Country | Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, the Netherlands |
Recruitment period | 2014-2015 |
Study population and number | n=184 patients |
Age and sex | Mean age 65.5±10.8 years, 63.6% male |
Patient selection criteria | Inclusion criteria: Stable or unstable angina, documented silent ischemia, a maximum of 2 single de novo lesions in 2 separate coronary arteries ≤21 mm in length. Exclusion criteria: MI within 72 hours prior to the index procedure, unprotected left main disease, 3-vessel CAD, heavily calcified lesions, unsuccessful pre-dilatation. |
Technique | Patients were implanted with DREAMS 2G (Magmaris by Biotronik AG) sirolimus-eluting magnesium bioresorbable scaffold. Pre-dilatation with a balloon ≤0.5 mm smaller than the RVD, but not exceeding the vessel diameter, and a ≤ lesion length was mandatory. Post-dilatation was performed according to the discretion of the investigator. DAPT was recommended for at least 6 months. |
Follow-up | 3 years |
Conflict of interest/source of funding | Study was funded by Biotronik. Authors reported receiving study grants, personal fees, and speaker fees from Biotronik and other companies. |
Analysis
Follow-up issues: 2 patients recruited did not have device implanted due to insufficient pre-dilatation. 2 patients missed follow-up visit and were subsequently not included in further analyses, and 6 patients were lost to follow-up. Overall 5.4% (10/184) of study population not included in 3 year follow-up.
Study design issues: Pooled case series combining data from BIOSOLVE-II and BIOSOLVE III studies. Endpoints at 3 years were TLF, a composite of cardiac death, target-vessel MI, coronary artery bypass grafting, and clinically driven TLR, and ScT.
Study population issues: 25% had diabetes, 23.4% with prior MI, 41.4% with previous coronary interventions.
Key efficacy findings
Number of patients analysed: 184
Clinical outcomes up to 3 years
Clinical outcome | 2 years % (n = 180) | 3 years % (n=174) |
TLF | 5.5 (10/184) | 6.3 (11/174) [95% CI: 3.2;11.0] |
All mortality* | 3.9 (7/184) | 5.2 (9/174) |
Cardiac mortality | 2.2 (4/184) | 2.3 (4/174) |
Target-vessel MI | 0.6 (1/184) | 0.6 (1/174) |
Clinically driven -TLR | 2.7 (5/184) | 3.4 (6/174) |
Clinically driven-TVR | 4.3 (8/184) | 5.2 (9/174) |
CABG | 0 (0/184) | 0 (0/174) |
*1 death at day 2 was probably due to a ventricular arrhythmia caused by a large infarction area after an ST-elevation MI that had occurred prior to the index procedure (autopsy confirmed the absence of ScT), 2 unwitnessed deaths occurred on day 134 and 395, and 1 non-arenaria died on day 574 of pre-existing chronic heart failure.
Angina status up to 3 years
Clinical outcome | Baseline % (n=184) | 12 months % (n=176) | 24 months % (n=173) | 36 months % (n=165) |
|---|---|---|---|---|
No pathological findings | 0 | 85.8 | 92.5 | 91.5 |
Stable angina | 75 | 13.1 | 7.5 | 8.5 |
Unstable angina | 12.5 | 0.6 | 0 | 0 |
Documented silent ischaemia | 12.5 | 0.6 | 0 | 0 |
53% of patients were on dual antiplatelet therapy at 12 months, 19% at 2 years and 16% at 3 years with magnesium-based SES BRS.
Key safety findings
No probable or definite ScT was reported throughout both studies.
Study 11 Chua SK (2017)
Study type | Case report and review |
|---|---|
Country | Taiwan |
Recruitment period | 2010-2013 |
Study population and number | n= 1 patient with angina and severe stenotic lesions in the middle LAD artery and LCx. |
Age and sex | 55 year old man |
Patient selection criteria | Not applicable |
Technique | PCI for the middle LCx with a 3.0 x 18mm and 3.5 x 28mm BRS that were post-dilated with 3.5mm and 3.75 mm non-compliant balloons. IVUS was used to confirm optimal expansion and good apposition of the 2 stents. |
Follow-up | 18 months |
Conflict of interest/source of funding | Not reported. |
Analysis
Study population issues: patient had hypertension and hyperlipidaemia.
Key safety findings
Number of patients analysed:1
Coronary artery aneurysm (CAA defined as in-scaffold diameter more than1.5 times the RVD)
18 months after the procedure, coronary angiography showed lumen dilatation and ectatic change with aneurysm formation over the BRS at the middle of LCx (50% increase in diameter compared to reference vessel) . OCT revealed absence of strut continuity and complete endothelialisation of sturt remnants at the aneurysm site, in the middle of the BRS. No further intervention for the aneurysm was done but DAPT was given to prevent thrombus formation. Patient had no further adverse events during 1 year follow-up.
In addition, further literature review identified 11 cases of CAA after BRS implantation (5 in the LAD, 3 in RCA, and 3 in LCx) which occurred between 2- 32 months. Patients did not have further intervention but long-term DAPT and early follow-up were adopted. One patient with in-scaffold restenosis in the middle of an aneurysm had subsequent implantation of a self-expanding DES. Another patient had a covered stent implantation for a CAA that had significantly increased in size at 1-year after BRS.
Study 12 Schinke K (2015)
Study type | Case report |
|---|---|
Country | Taiwan |
Recruitment period | 2010-2013 |
Study population and number | n= 1 patient with CAD and prior bare-metal stenting of the LAD had both de-novo-stenosis and in-stent restenosis within the LAD stent and presented with recurrent exertional angina. |
Age and sex | 45 year old man |
Patient selection criteria | Not applicable |
Technique | PCI after pre-dilatation with a completely expanded 2.5 x 20-mm balloon, a BRS (Abbott, Absorb, 2.5 x 28 mm) was positioned in the region of the de-novo-stenosis distal of the former stent and inflated stepwise to an end-pressure of 12 atm which was held for 30 seconds to achieve optimal expansion. |
Follow-up | During implantation |
Conflict of interest/source of funding | None. |
Key safety findings
Number of patients analysed:1
Vessel perforation
Post-inflation angiography revealed a large extravasation caused by a broad perforation at the convex side of the vessel, likely due to fatigue and fracturing of the scaffold struts leading to a broad laceration. To prevent pericardial tamponade a 2.5 x 20 mm balloon was positioned across the ruptured region and inflated. Afterwards a covered stent graft, (2.5 x18 mm) was implanted within the scaffold sealing the perforation successfully. Finally, both the proximal de-novo-stenosis and the restenosis of the former LAD stent were treated with additional implantation of a 2.5 x 28mm XIENCE everolimus-eluting metallic stent with an excellent final result.
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