First clinical evidence characterizing safety and efficacy of the new CoCr Biolimus-A9 eluting stent: The Biomatrix Alpha™ registry

• Main Authors: Ian B.A. Menown, Mamas A. Mamas, James M. Cotton, David Hildick-Smith, Franz R. Eberli, Gregor Leibundgut, Damras Tresukosol, Carlos Macaya, Samuel Copt, Sara Sadozai Slama, Hans-Peter Stoll
• Format: Article
• Language: English
• Published: Elsevier 2020-02-01
• Series: International Journal of Cardiology: Heart & Vasculature
• Online Access: http://www.sciencedirect.com/science/article/pii/S235290672030004X

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. Keywords: Drug eluting stent, Biodegradable polymer, Cobalt-chromium, Strut thickness, Myocardial infarction, Stent thrombosis