Milvexian with Antiplatelet Therapy after Acute Coronary Syndrome Event.
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Gibson C Michael, Steg P Gabriel, Bahit M Cecilia, Al-Lamee Rasha, Mehta Shamir R, Mehran Roxana, Weitz Jeffrey I, Goto Shinya, Nicolau Jose Carlos, Lopes Renato D, Ge Junbo, Tasic Nebojsa, Angiolillo Dominick J, Baron Suzanne J, Kirtane Ajay J, Xavier Denis, Yasuda Satoshi, Lewis Basil S, Park Duk-Woo, Cornel Jan H, Johnson Thomas W, Trebacz Jaroslaw, Duerschmied Daniel, Bode Christoph, Merkely Bela, Dorobantu Maria, Vinereanu Dragos, Motovska Zuzana, Bueno Hector, Lopez-Sendon Jose Luis, Ducrocq Gregory, Ambrosio Giuseppe, Burgess Lesley, Bohm Allan, Chiang Chern-En, Morais Joao, Fong Alan, Guray Umit, Leiva-Pons Jose Luis, Vranckx Pascal, White Harvey D, Kedev Sasko, Valgimigli Marco, Cerovec Duško, Tousoulis Dimitris, Figtree Gemma, Ho Thuong Dung, Sy Rody G, Bøttcher Morten, Huber Kurt, Slapikas Rimvydas, Erglis Andrejs, Tan Jack Wei Chieh, Pincetti Christian, Pieper Karen S, Mahaffey Kenneth W, Lam Carolyn S P, Johnston S Claiborne, Hankey Graeme J, Zheng Luke, Aronson Ronald, Li Danshi, Notani Ravi, Vieira Pires Philippe, Povsic Thomas J, Lindsay Alistair C, Plotnikov Alexei, Deng Hsiaowei, Barnathan Elliot S, Harrington Robert A, LIBREXIA ACS Committees and Investigators
Аннотация
METHODS: In this phase 3, randomized, placebo-controlled trial, we evaluated the efficacy and safety of milvexian when added to standard antiplatelet therapy within 7 days after an acute coronary syndrome event. Patients were assigned in a 1:1 ratio to receive oral milvexian (25 mg twice daily) or matched placebo. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or ischemic stroke as evaluated in a time-to-event analysis. The principal safety outcome was Bleeding Academic Research Consortium (BARC) type 3c or 5 bleeding (intracranial or intraocular bleeding that compromises vision or fatal bleeding).
RESULTS: After a planned interim analysis that was based on 556 adjudicated efficacy end points, the trial was terminated for futility. A total of 14,194 patients had been enrolled, with 7094 assigned to receive milvexian and 7100 to receive placebo. After a median follow-up of 12.2 months, a primary efficacy outcome event had occurred in 384 patients (5.4%) in the milvexian group and in 365 patients (5.1%) in the placebo group (hazard ratio, 1.05; 95% confidence interval, 0.91 to 1.21; P = 0.50). BARC type 3c or 5 bleeding occurred in 23 patients (0.3%) in the milvexian group and in 22 patients (0.3%) in the placebo group (P = 0.88).
CONCLUSIONS: Among patients with a recent acute coronary syndrome event, milvexian did not decrease the risk of cardiovascular death, myocardial infarction, or ischemic stroke but did not increase the risk of intracranial or fatal bleeding, as compared with placebo. (Funded by Janssen Research and Development and Bristol Myers Squibb; LIBREXIA ACS ClinicalTrials.gov number, NCT05754957.).