4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 In a case series of 30 patients treated by drug-eluting bioresorbable stents, device success (defined as 'successful stent delivery and deployment at the intended target lesion with attainment of a final residual stenosis of less than 50%') was reported in 94% of patients (29/31 attempts). The bioresorbable stent dislodged (needing bailout stenting) in 2 patients. Procedure success (defined as 'clinical device success with any adjunctive device without the occurrence of major adverse cardiac events [MACE] related to ischaemia up to 7 days after the index procedure') was reported in 100%.

4.2 In a case series of 50 patients treated by non-drug eluting bioresorbable stents, survival rates free of all-cause death, cardiac death and MACE at 10 years were 87%, 98% and 50% respectively. Cumulative rates of MACE (defined in this series as including both cardiac and non-cardiac death) during the 10-year follow-up period were 4% (2/50) scaffold thrombosis (1 sub-acute and 1 very late at 10 years), 14% (7/50) deaths (1 cardiac death, 6 non-cardiac deaths), 8% (4/50) myocardial infarctions, and 38% (21/50) target vessel revascularisations.

4.3 In a case series of 63 patients treated with drug-eluting bioresorbable stents, MACE (defined as cardiac death, Q wave myocardial infarction and need for revascularisation of the target lesion) were reported in 24% (15/63) of patients at 4 months follow-up. The overall MACE rate was 27% (16/60) at 12 months follow-up and these were all target lesion revascularisations. There were no deaths or myocardial infarctions.

4.4 A comparative case series of 253 patients (150 treated with drug-eluting bioresorbable stents and 103 treated with drug-eluting stents) reported that in-hospital, 30-day and 6-month cumulative MACE rates were similar between both groups (all p>0.5), with most complications occurring during the first 10 days.

4.5 In the case series of 30 patients, 52% (15/29) of patients were on dual antiplatelet therapy at 1 year. At 5 years clopidogrel had been discontinued in all but 1 patient.

4.6 The specialist advisers listed key efficacy outcomes as successful deployment of the device, a reduced need for dual antiplatelet therapy (leading to a reduced risk of bleeding complications), rates of stent thrombosis and target vessel revascularisation 'at intervals' greater than 12 months.

  • National Institute for Health and Care Excellence (NICE)