Everolimus-Eluting Bioresorbable Scaffolds vs. EES
What is the comparative effectiveness of the bioresorbable scaffold (BVS) versus everolimus-eluting stent (EES) in patients undergoing percutaneous coronary intervention (PCI)?
The authors performed a meta-analysis of seven trials that randomized patients to BVS versus EES. The primary efficacy endpoint was target lesion failure, and safety endpoint was definite/probable stent thrombosis.
The seven included trials enrolled 5,583 patients who were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Over a median follow-up of 2 years, use of BVS was associated with a greater risk of target lesion failure (9.6% vs. 7.2%; risk ratio [RR], 1.32; 95% confidence interval [CI], 1.10-1.59; number needed to harm [NNH] = 41; p = 0.003) and stent thrombosis (2.4% vs. 0.7%; RR, 3.15; 95% CI, 1.87 -5.30; NNH = 60; p < 0.0001). There were no significant differences in all-cause or cardiovascular mortality between groups. The risk for stent thrombosis in association with BVS was consistently elevated across the available follow-up and was evident across the early (<30 days), late (30 days to 1 year), and very late (>1 year) periods.
Compared with EES, BVS appears to be associated with increased target lesion failure and a higher risk of stent thrombosis.
This meta-analysis corroborates the safety concerns noted in association with BVS in multiple randomized controlled trials. Given these data, and in view of the excellent outcomes seen with second-generation DES, use of BVS should be restricted to rare patients with unique clinical issues. Further, among patients who have already been treated with a BVS, it would be reasonable to consider prolonged dual antiplatelet therapy until more follow-up data become available.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention
Keywords: Absorbable Implants, Drug-Eluting Stents, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Risk, Stents, Thrombosis
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