Background: Bioresorbable vascular scaffolds (BVS) completely resorb within 3 years after placement into the coronary artery. The safety and effectiveness of bioabsorbable scaffolds are of critical importance during this 3-year period.
Objective: We performed a meta-analysis to compare the safety and efficacy of BVS and second-generation drug-eluting stents (DES) at 3 years after implantation.
Methods: Published randomized trials comparing BVS to second-generation DES for the treatment of coronary artery disease were identified within PubMed, EMBASE, Cochrane Library, Web of Science, and relevant Web sites with publication dates through June 2019. The primary efficacy endpoint was target lesion failure. The primary safety endpoint was definite/probable stent/scaffold thrombosis. Secondary outcomes were cardiac death, target vessel myocardial infarction, ischemia-driven target lesion revascularization, and a patient-oriented composite end point.
Results: Six randomized controlled trials, with a total of 5,412 patients (BVS n = 3,177; DES n = 2,235), were included. At 3 years, BVS was associated with higher rates of target lesion failure (OR = 1.33, 95%CI: 1.10-1.60, P = 0.003) and definite/probable stent/scaffold thrombosis (OR = 3.75, 95% CI: 2.22-6.35, P < .00001)compared with DES. The incidence of target vessel myocardial infarction (OR = 1.68, 95% CI: 1.30-2.17, P < .0001), ischemia-driven target lesion revascularization (OR = 1.46, 95% CI: 1.14-1.86, P = .003), and the patient-oriented composite end point(OR = 1.20, 95% CI: 1.04-1.39, P = .01) were higher for those treated with BVS compared with DES. However, there was no significant difference in risk of cardiac death (OR = 0.94, 95%CI: 0.61-1.45, P = .79) between treatment groups.
Conclusions: At the 3-year follow-up, BVS was inferior to second-generation DES in both safety and efficacy.