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. 2020 Jan 27:26:100472.
doi: 10.1016/j.ijcha.2020.100472. eCollection 2020 Feb.

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

Ian B A Menown  1 , Mamas A Mamas  2 , James M Cotton  3 , David Hildick-Smith  4 , Franz R Eberli  5 , Gregor Leibundgut  6 , Damras Tresukosol  7 , Carlos Macaya  8 , Samuel Copt  9 , Sara Sadozai Slama  9 , Hans-Peter Stoll  9
Affiliations

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

Ian B A Menown et al. Int J Cardiol Heart Vasc. .

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.

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

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Conflict of interest statement

SC, SSS, and HPS are employed by Biosensors. IM has received conference sponsorship from Biosensors. No other authors have any conflicts to declare.

Figures

Fig. 1
Fig. 1
A: Flattened view of the cobalt chromium stent platform (small vessel model) B: Details of the straight and curved link connectors C: Comparison with LEADERS (historical control), with propensity matching and landmark analysis at day 3 for the primary endpoint of major adverse cardiac events at 9 months.
See this image and copyright information in PMC

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