Efficacy and Safety of Bioresorbable Vascular Scaffolds Versus Contemporary Drug-Eluting Stents in Coronary Artery Disease: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis

Background: Bioresorbable vascular scaffolds (BVS) were developed to address some limitations associated with permanent metallic drug-eluting stents (DES), but the comparative safety and efficacy of these scaffolds remain uncertain. Methods: We conducted a systematic review and meta-analysis of randomized and observational studies comparing BVS with contemporary DES in patients with coronary artery disease. The primary outcome was the composite clinical endpoint at 1-year. Secondary outcomes included mortality, myocardial infarction (MI), revascularization, thrombosis, and angiographic measures. Outcomes at 2, 3, and 5 years were analyzed separately. Trial sequential analysis (TSA) was used to assess the robustness of the evidence for the primary outcome. Results: A total of 51 studies (69 reports) were included. At 1 year, BVS was associated with a higher risk of the composite clinical endpoint than DES (risk ratio (RR) 1.11, 95% confidence interval (CI 1.00–1.22)), mainly driven by increased risks of MI, target lesion revascularization, and thrombosis. In contrast, all-cause and cardiac mortality did not differ significantly between groups. TSA showed that although the cumulative Z-curve reached the required information size, the Z-score did not cross the trial sequential monitoring boundary, indicating that the evidence for the primary endpoint remained inconclusive. During mid- and long-term follow-up, BVS remained associated with higher risks of ischemic events and repeat revascularization, without a survival benefit. Angiographic analyses showed greater late lumen loss, smaller minimal lumen diameter, and greater diameter stenosis with BVS. Conclusions: Compared with contemporary DES, BVS appears to confer a higher ischemic risk without a long-term mortality benefit. Contemporary DES remains the preferred revascularization strategy.