Menown, IBA, Mamas, MA ORCID: https://orcid.org/0000-0001-9241-8890, Cotton, JM, Hildick-Smith, D, Eberli, FR, Leibundgut, G, Tresukosol, D, Macaya, C, Copt, S, Slama, SS and Stoll, H-P (2020) First clinical evidence characterizing safety and efficacy of the new CoCr Biolimus-A9 eluting stent: The Biomatrix Alpha™ registry. IJC Heart & Vasculature, 26.

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Abstract

Background The biolimus-eluting stent (BES) was the first to elute anti-proliferative drug from a biodegradable polymer. In the randomized LEADERS trial, a stainless steel BES showed non-inferior efficacy compared to a sirolimus-eluting stent and a long-term safety advantage. We report the first clinical efficacy and safety outcomes of a new thin-strut cobalt chromium biolimus-eluting stent (CoCr-BES) from an international multi-centre registry. Methods We studied 400 all-comer patients with coronary disease receiving CoCr-BES at 12 centres, with follow-up at 9 months and 2 years. The primary endpoint was incidence of major adverse cardiac events (MACE) at 9 months comprising cardiac death, myocardial infarction (MI), and clinically indicated target vessel revascularization (ci-TVR). Key protocol elements were the same as the randomized LEADERS trial to enable a historical control for propensity-matched comparison. Results Mean patient age was 65 ± 11 years, 19% had diabetes, and 55% presented with unstable angina or MI. On discharge, 96% of patients were on dual antiplatelet therapy (DAPT) and 69% were on DAPT at 9 months. MACE at 9 months occurred in 3.9% of patients, cardiac death in 0.8%, MI in 1.1% and ci-TVR in 2.7%. One patient (0.25%) experienced definite or probable stent thrombosis (ST). A propensity-adjusted comparison showed similar clinical outcomes to the BES arm in the LEADERS trial for the primary endpoint MACE. Conclusions The new CoCr-BES showed low rates of MACE, MI, ci-TVR and ST at 9 months, similar to the BES arm in LEADERS.

Item Type: Article
Additional Information: This is the final published version of the article (version of record). It first appeared online via Elsevier at https://doi.org/10.1016/j.ijcha.2020.100472 - please refer to any applicable terms of use of the publisher.
Uncontrolled Keywords: Drug eluting stent; Biodegradable polymer; Cobalt-chromium; Strut thickness; Myocardial infarction; Stent thrombosis
Subjects: R Medicine > RC Internal medicine > RC666 Diseases of the circulatory (Cardiovascular) system
Divisions: Faculty of Medicine and Health Sciences > Institute for Science and Technology in Medicine
Depositing User: Symplectic
Date Deposited: 26 Feb 2020 12:00
Last Modified: 07 May 2020 10:22
URI: https://eprints.keele.ac.uk/id/eprint/7721

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