Milvexian Fails to Reduce Ischemic Events After ACS

A large phase 3 trial establishes that adding the oral factor XIa inhibitor milvexian to contemporary antiplatelet therapy after acute coronary syndrome does not lower ischemic events, closing a long-pursued anticoagulant hypothesis in this population.

📅 Journal publication: Aug 29, 2026 · Last updated: Oct 12, 2026

★ Editor's Pickmilvexianfactor XIa inhibitoranticoagulationacute coronary syndromeantiplatelet therapyDAPTsecondary preventionLIBREXIA ACSphase 3 trialbleedingP2Y12 inhibitor Anticoagulation / Hematology

Also in Cardiology

Background Information

Adding a factor XIa inhibitor to antiplatelet therapy after ACS did not prevent cardiovascular events.

The study evaluates the efficacy and safety of milvexian, a factor XIa inhibitor, added to antiplatelet therapy after an acute coronary syndrome (ACS) event. In 14,194 patients randomized within 7 days of an ACS, milvexian 25 mg twice daily added to standard antiplatelet therapy did not reduce cardiovascular death, MI or ischemic stroke versus placebo (5.4% vs 5.1%; HR 1.05, 95% CI 0.91-1.21). Intracranial or fatal bleeding was 0.3% in both arms. The trial was stopped early for futility. Factor XIa inhibition has now failed after ACS and in atrial fibrillation (OCEANIC-AF); its only positive phase 3 result remains secondary stroke prevention (OCEANIC-STROKE). Milvexian is not FDA-approved, and nothing supports using a factor XIa inhibitor after ACS. Do not extrapolate factor XIa benefit from stroke to coronary disease: adding milvexian after ACS prevented no events.

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Authors: Gibson CM, Steg PG, Bahit MC, Al-Lamee R, Mehta SR, Mehran R, Weitz JI, Goto S, Nicolau JC, Lopes RD, Ge J, Tasic N, Angiolillo DJ, Baron SJ, Kirtane AJ, Xavier D, Yasuda S, Lewis BS, Park DW, Cornel JH, Johnson TW, Trebacz J, Duerschmied D, Bode C, Merkely B, Dorobantu M, Vinereanu D, Motovska Z, Bueno H, Lopez-Sendon JL, Ducrocq G, Ambrosio G, Burgess L, Bohm A, Chiang CE, Morais J, Fong A, Guray U, Leiva-Pons JL, Vranckx P, White HD, Kedev S, Valgimigli M, Cerovec D, Tousoulis D, Figtree G, Ho TD, Sy RG, Bøttcher M, Huber K, Slapikas R, Erglis A, Tan JWC, Pincetti C, Pieper KS, Mahaffey KW, Lam CSP, Johnston SC, Hankey GJ, Zheng L, Aronson R, Li D, Notani R, Vieira Pires P, Povsic TJ, Lindsay AC, Plotnikov A, Deng H, Barnathan ES, Harrington RA, LIBREXIA ACS Committees and Investigators

Citation: Gibson CM, Steg PG, Bahit MC, et al. Milvexian with Antiplatelet Therapy after Acute Coronary Syndrome Event. The New England journal of medicine. 2026. doi:10.1056/NEJMoa2608717

Article Links: PubMed · Journal / DOI

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