TCT CONNECT-266 Cobalt Chromium Biolimus Drug-Eluting Stents Compared With Stainless Steel Biolimus Drug-Eluting Stents: Final Results of BMX Alpha

Alexander Menown, Ian Brian; Mamas, Mamas; Cotton, James; Hildick-Smith, David; Eberli, Franz; Leibundgut, Gregor; Tresukosol, Damras; Macaya, Carlos; Copt, Samuel; Slama, Sara Sadozai; Oldroyd, Keith

Abstract

Background
Thinner stent struts may improve deliverability and conformability and reduce vessel injury. The final clinical outcomes of the thinner strut (84 to 88 μm) cobalt chromium biolimus eluting stent from the BioMatrix (BMX) Alpha registry are reported and are compared with objective performance criteria from the stainless steel BMX Flex arm of the Leaders study.

Methods
A total of 1,257 patients were studied: 400 patients from 12 centers receiving ≥1 BMX Alpha stent were prospectively enrolled into the BMX Alpha registry and then underwent a pre-specified comparison with 857 patients who received a BMX Flex stent in the Leaders study. The primary endpoint was major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization at 9 months. Assuming a 9.2% event rate with BMX Flex, a 1-sided type I error (α) of 0.05, and a 4% noninferiority margin, a sample size of 400 in the BMX Alpha registry had >80% power to conclude noninferiority.

Results
Baseline characteristics in BMX Alpha were typical of an all-comers population with a mean age of 64.7 ± 11.3 years, diabetes 19%, current smoking 21%, dyslipidemia 57%, hypertension 57%, total stent length per lesion 25.49 ± 13.45 mm, mean stents per procedure 1.59 ± 0.88, and overlapping stents in 13.4%. MACE at 9 months with BMX Alpha was 3.94% (95% confidence interval: 2.29% to 6.19%) versus 9.28% MACE rate with BMX Flex stents in Leaders, which met pre-specified criteria for noninferiority (p < 0.001) and on post hoc testing for superiority yielded p < 0.001 for BMX Alpha versus BMX Flex. At 2 years, MACE with BMX Alpha was 6.65% (95% confidence interval: 4.14 to 9.09) versus 12.26% (95% confidence interval: 9.67 to 14.77) with BMX Flex; p superiority = 0.0030. Secondary clinical endpoints in BMX Alpha at 30 days, 9 months, and 2 years are shown in the table.

Citation

Alexander Menown, I. B., Mamas, M., Cotton, J., Hildick-Smith, D., Eberli, F., Leibundgut, G., …Oldroyd, K. (2020). TCT CONNECT-266 Cobalt Chromium Biolimus Drug-Eluting Stents Compared With Stainless Steel Biolimus Drug-Eluting Stents: Final Results of BMX Alpha. Journal of the American College of Cardiology, 76(17), B116. https://doi.org/10.1016/j.jacc.2020.09.283

• Journal Article Type: Article
• Online Publication Date: Oct 22, 2020
• Publication Date: 2020-10
• Deposit Date: Jun 21, 2023
• Journal: Journal of the American College of Cardiology
• Print ISSN: 0735-1097
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 76
• Issue: 17
• Pages: B116
• DOI: https://doi.org/10.1016/j.jacc.2020.09.283
• Keywords: Cardiology and Cardiovascular Medicine
• Additional Information: This article is maintained by: Elsevier; Article Title: TCT CONNECT-266 Cobalt Chromium Biolimus Drug-Eluting Stents Compared With Stainless Steel Biolimus Drug-Eluting Stents: Final Results of BMX Alpha; Journal Title: Journal of the American College of Cardiology; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.jacc.2020.09.283; Content Type: simple-article; Copyright: Copyright © 2020 Published by Elsevier Inc.