Long-Term Safety and Efficacy of Bioresorbable Vascular Scaffolds Versus Metallic Stents Compared in Meta-Analysis

May 8, 2017—A meta-analysis of randomized trials evaluating the long-term safety and efficacy of everolimus-eluting bioresorbable vascular scaffolds (BVS) versus everolimus-eluting metallic stents (EES) was published by Ahmed N. Mahmoud, MD, et al online ahead of print in Circulation: Cardiovascular Interventions.

The investigators concluded that in these studies, BVS, compared with EES, was associated with an increased risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization. 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, advised the investigators.

As summarized in Circulation: Cardiovascular Interventions, the meta-analysis included randomized trials reporting clinical outcomes beyond 1 year and comparing BVS with EES. Summary estimates of 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 5,392 patients were included (mean follow-up, 25 months).

The investigators found that 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, reported the investigators in Circulation: Cardiovascular Interventions.