Everolimus-Eluting Bioresorbable Vascular Scaffolds
What is the efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ischemic heart disease treated with percutaneous revascularization?
The investigators searched Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific session’s abstracts, and relevant websites for randomized trials investigating everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents published or posted between November 30, 2006, and October 12, 2015. The primary efficacy outcome was target lesion revascularization and the primary safety outcome was definite or probable stent (scaffold) thrombosis. Secondary outcomes were target lesion failure (the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization), myocardial infarction, death, and in-device late lumen loss. The authors derived odds ratios (ORs) and weighted mean differences with 95% confidence intervals (CIs), and calculated the risk estimates for the main outcomes according to a random-effects model.
Six trials were included comprising data for 3,738 patients randomized to receive percutaneous coronary intervention with either an everolimus-eluting bioresorbable vascular scaffold (n = 2,337) or an everolimus-eluting metallic stent (n = 1,401). Median follow-up was 12 months (interquartile range, 9-12). Patients treated with bioresorbable vascular scaffolds had a similar risk of target lesion revascularization (OR, 0.97 [95% CI, 0.66-1.43]; p = 0.87), target lesion failure (1.20 [0.90-1.60]; p = 0.21), myocardial infarction (1.36 [0.98-1.89]; p = 0.06), and death (0.95 [0.45-2.00]; p = 0.89) as those treated with metallic stents. Patients treated with a bioresorbable vascular scaffold had a higher risk of definite or probable stent thrombosis than those treated with a metallic stent (OR, 1.99 [95% CI, 1.00-3.98]; p = 0.05), with the highest risk between 1 and 30 days after implantation (3.11 [1.24-7.82]; p = 0.02). Lesions treated with a bioresorbable vascular scaffold had greater in-device late lumen loss than those treated with a metallic stent (weighted mean difference, 0.08 [95% CI, 0.05-0.12]; p < 0.0001).
The authors concluded that compared with everolimus-eluting metallic stents, everolimus-eluting bioresorbable vascular scaffolds had similar rates of repeat revascularization at 1 year of follow-up, despite inferior mid-term angiographic performance.
This analysis reports that everolimus-eluting bioresorbable vascular scaffolds had similar rates of repeat revascularization at 1 year of follow-up as compared with everolimus-eluting metallic stents, despite inferior mid-term angiographic performance. However, patients treated with a bioresorbable vascular scaffold had an increased risk (two times higher) of subacute stent thrombosis. This would suggest that studies with extended follow-up in a larger number of patients are needed to fully assess the long-term advantages/disadvantages of everolimus-eluting bioresorbable vascular scaffolds.
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