Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: Two-year clinical outcomes of the EVERBIO II trial

Background: Data from randomized controlled trials have shown that the ABSORB BVS is non-inferior to Cobalt Chromium everolimus-eluting stents at 2 years. Methods & results: The EVERBIO II trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus- Eluting Bioresorbable Vascular Scaffold) is a single-center, assessor-blind, randomized controlled trial enrolling 240 patients with an allocation ration of 1: 1: 1 conducted at University and Hospital Fribourg, Switzerland. The studied devices were an everolimus- eluting persistent polymer stent(EES), a biolimuseluting stent with bioabsorbable polymer (BES) and a fully bioresorbable vascular scaffold (BVS). Clinical end points collected at 9 months, 12 months, and 2 years, were academic research consortium defined composites, device thrombosis and target-vessel revascularization. Clinical follow-up at 2 years was available in 96% (N= 77) of patients in the EES group, in 100% (N= 80) in the BES and 99% (N= 77) in the BVS group. The device-oriented composite end point of cardiac death, target-vessel myocardial infarction and target-lesion revascularization occurred in 13 (16%) patients treated with EES, in 7 (9%) patients treated with BES and in 16 (21%) patients treated with BVS. There was no significant difference when the metallic stents were compared to the BVS (p= 0.12). There was one late scaffold thrombosis throughout the trial in the BVS group, and no definite stent thrombosis in either EES or BES treated patients. Conclusions: The current analysis shows no significant differences with regard to clinical outcomes at 2 years between BVS and the best-in-class metallic DES. Event rates were numerically higher in BVS-treated patients. However, when BVS were compared to BES alone, the occurrence of device related adverse events was significantly increased. (C) 2017 Published by Elsevier Ireland Ltd.