Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease: Aweighted meta-analysis of seven randomised controlled trials including 5577 patients.

J Elias,R J De Winter,J J Wykrzykowska,I M Van Dongen,R P Kraak,J J Piek,J G P Tijssen,J P S Henriques,B E P M Claessen,R Y G Tijssen

doi:10.1007/s12471-017-1008-x

Abstract

AimsMid- and long-term safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) have been studied in randomised trials; however, most were not individually powered for clinical endpoints. We performed a weighted meta-analysis comparing mid- and long-term outcomes in patients treated with the BVS compared with the Xience metallic stent.Methods and resultsRandomised trials comparing the BVS and Xience were identified by searching MEDLINE, EMBASE and conference abstracts. Seven trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1–3 years. The primary outcome of target lesion failure occurred more frequently in BVS compared with Xience [OR 1.34; 95% CI 1.11–1.62, p = 0.003]. Overall definite or probable device thrombosis occurred more frequently with the BVS [OR 2.86; 95% CI 1.88–4.36, p < 0.001] and this extended beyond 1 year of follow-up [OR 4.13; 95% CI 1.99–8.57, p < 0.001]. Clinically indicated or ischaemia driven target lesion revascularisation [OR 1.43; 95% CI 1.11–1.83, p = 0.005] and myocardial infarction (all MI) [OR 1.64; 95% CI 1.20–2.23, p = 0.002] were more frequently seen in the BVS compared with Xience. Rates of target vessel failure [OR 1.15; 95% CI 0.91–1.46, p = 0.25] and cardiac death [OR 0.91; 95% CI 0.57–1.46, p = 0.71] were not significantly different between BVS and Xience.ConclusionThis meta-analysis shows a higher rate of target lesion failure and an almost threefold higher rate of device thrombosis in BVS compared with Xience, which extends beyond the first year. Device thrombosis did not lead to an overall increased (cardiac) mortality.Electronic supplementary materialThe online version of this article (doi: 10.1007/s12471-017-1008-x) contains supplementary material, which is available to authorized users.

Highlights

Bioresorbable scaffolds may theoretically overcome some limitations of current generation drug-eluting stents [1]
Excluding these trials did not lead to a major difference in primary outcomes (ESM Fig. 4). This meta-analysis showed a higher target lesion failure in bioresorbable vascular scaffold (BVS) compared with the Xience
In BVS, a highly significantly increased risk for definite and probable device thrombosis was observed compared with Xience

Summary

Introduction

Bioresorbable scaffolds may theoretically overcome some limitations of current generation drug-eluting stents [1]. Registries performed in more complex patients and lesions reported higher rates of early and late scaffold thrombosis [8,9,10]. In the ABSORB II trial, an ongoing risk of scaffold thrombosis up to 3 years of follow-up was observed [11]. The ABSORB III trial showed significantly higher 2-year target lesion failure in the BVS compared with Xience [12], leading to an US Food and Drug Administration (FDA) warning [13]. The AIDA trial included a patient population reflecting routine clinical practice, and reported data earlier due to safety concerns. In AIDA, treatment with the BVS compared with Xience was associated with an increased incidence of device thrombosis throughout a median follow-

Methods

Results

Conclusion