Long-Term Efficacy and Safety of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Metallic Stents

Second-generation metallic drug-eluting stents (DES) have been widely recommended for percutaneous coronary intervention. One of the main drawbacks of these devices is the risk of late adverse events (ie, beyond 1 year), particularly repeat revascularization, which are partly related to the persistence of the metallic stents in the coronary artery wall. In this context, the bioresorbable vascular scaffolds (BVS) have emerged as an attractive breakthrough technology. These scaffolds offer the mechanical support similar to DES followed by complete resolution within 3 to 4 years, thus, maintaining the coronary vasomotion, which is reduced with DES and has been linked to the increased risk of repeat revascularization. Preclinical studies with BVS had shown that these devices improve vessel remodeling once resolved. The AbsorbTM (Abbott Vascular, Abbott Park, IL) BVS has been the widely commercially available among the different BVS in development. The US Food and Drug Administration recently approved the AbsorbTM BVS; AbsorbTM this was based on the results of the 1-year data from the largest randomized trial to date (ie, ABSORB III trial [A Clinical Evaluation of AbsorbTM BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With De Novo Native Coronary Artery Lesions]) evaluating clinical outcomes with the AbsorbTM BVS and demonstrated the noninferiority of BVS compared with everolimus-eluting stents (EES) at 1 year. Data from meta-analyses suggested that BVS might be associated Background—Data regarding the long-term efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents are limited. This meta-analysis aimed to compare the long-term outcomes with both devices. Methods and Results—Randomized trials reporting clinical outcomes beyond 1 year and comparing BVS with everolimuseluting stents were included. Summary estimates risk ratios (RRs) were constructed. The primary efficacy outcome was target lesion failure, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, and the primary safety outcome was definite or probable stent/scaffold thrombosis. Six trials with 5392 patients were included (mean follow-up, 25 months). BVS had a higher rate of target lesion failure (RR, 1.33; 95% confidence interval [CI], 1.11–1.58) driven by the higher rates of target vessel myocardial infarction (RR, 1.65; 95% CI, 1.26–2.17) and target lesion revascularization (RR, 1.39; 95% CI, 1.08–1.78). The risk of definite or probable stent/ scaffold thrombosis (RR, 3.22; 95% CI, 1.89–5.49) and very late stent/scaffold thrombosis (>1 year; RR, 4.78; 95% CI, 1.66–13.8) was higher with BVS. The risk of cardiac and all-cause mortality was similar in both groups. Conclusions—Compared with everolimus-eluting stents, BVS is associated with increased risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization in these studies (mean follow-up, 25 months). The risk of definite or probable stent/scaffold thrombosis and very late stent/scaffold thrombosis seems to be higher with BVS. Further information from randomized trials is critical to evaluate clinical outcomes with BVS on complete resolution of the scaffold. (Circ Cardiovasc Interv. 2017;10:e005286. DOI: 10.1161/CIRCINTERVENTIONS.117.005286.)