Comparison of Everolimus- and Biolimus-Eluting Coronary Stents With€Everolimus-Eluting Bioresorbable Vascular Scaffolds

Fro ini Du an res da Bio (CR Lis Yo Ma BACKGROUND The first CE-approved bioresorbable vascular scaffold (BVS) is effective at treating simple lesions and stable coronary artery disease, but it has yet to be assessed versus the best-in-class drug-eluting stents (DES). OBJECTIVES This study sought to compare the performance of a BVS with that of everolimus-eluting stents (EES) and biolimus-eluting stents (BES) in all-comer patients. METHODS The EVERBIO II (Comparison of Everolimusand Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II) trial was a single-center, assessor-blinded study of 240 patients randomly assigned in a 1:1:1 ratio to EES, BES, or BVS. The only exclusion criterion was a reference vessel diameter >4.0 mm, which precluded treatment with BVS. The primary endpoint was angiographic late lumen loss (LLL) at 9 months. Secondary endpoints included patient-oriented major acute coronary events (MACE) (death, myocardial infarction [MI], and any revascularization), device-oriented MACE (cardiac death, MI, and target lesion revascularization), and stent thrombosis at the 9-month clinical follow-up. RESULTS Follow-up angiography was performed in 216 patients (90.7%) at 9 months. In-stent LLL was similar between patients treated with BVS (0.28 0.39 mm) and those treated with EES/BES (0.25 0.36 mm; p 1⁄4 0.30). Clinical outcomes were similar at 9 months: the patient-oriented MACE rate was 27% in BVS and 26% in the EES/BES group (p 1⁄4 0.83) and the device-oriented MACE rate was 12% in BVS and 9% in the EES/BES group (p 1⁄4 0.6). CONCLUSIONS New-generation metallic DES (EES/BES) were not superior to BVS in terms of angiographic LLL and clinical outcomes. (Comparison of Everolimusand Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [EVERBIO II]; NCT01711931) (J Am Coll Cardiol 2015;65:791–801) © 2015 by the American College of Cardiology Foundation. D rug-eluting stents (DES) have greatly reduced the risk of restenosis compared with bare-metal stents and have become the standard of care for patients undergoing m the Department of Cardiology, Fribourg University and Hospital, Fr tiated study supported by an unrestricted grant from the Fonds Sci ring the study period, the Fonds Scientifique Cardiovasculaire received ed d Biosensors International and a dedicated unrestricted grant from Bost earch program (ISRCAR310040). The funding sources had no role in the d ta analysis, data interpretation, or writing of the report. Dr. Cook has rec sensors International, and Boston Scientific; and receives suppor 32I3_150271/1). All other authors have reported that they have no relations ten to this manuscript’s audio summary by JACC Editor-in-Chief Dr. Vale u can also listen to this issue’s audio summary by JACC Editor-in-Chief Dr nuscript received August 17, 2014; revised manuscript received Novembe percutaneous coronary intervention (PCI) (1). However, the durable polymer within the vessel is considered responsible for ongoing inflammation, leading to late complications such as stent thrombosis and ibourg, Switzerland. This trial was an investigatorentifique Cardiovasculaire (Fribourg, Switzerland). ucational and research grants from Abbott Vascular on Scientific through the independent investigator esign of the study, data collection, data monitoring, eived speaker fees/honoraria from Abbott Vascular, t from the Swiss National Science Foundation hips relevant to the contents of this paper to disclose. ntin Fuster. . Valentin Fuster. r 18, 2014, accepted December 2, 2014. ABBR EV I A T I ON S