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Factor XI inhibitors in patients with cardiovascular disease and a high risk of bleeding: a cautionary tale

Factor XIa inhibitors are being tested in clinical trials, with the assumption that these agents are as effective as direct oral anticoagulants but cause fewer bleeding events. Findings from phase II trials of direct inhibitors of factor XIa for the prevention of first-ever and recurrent ischaemic stroke or recurrent major coronary artery events suggest fewer bleeding events but with uncertainty about efficacy.

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Fig. 1: Coagulation cascade and current and future clinical applications of factor XI inhibitors in cardiovascular disease.

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Correspondence to Hugo ten Cate.

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Competing interests

H.t.C. has received consultancy fees from Aleveron, AstraZeneca, Galapagos and Novostia and research funding from Bayer; all revenues are deposited at the CARIM Institute and labelled for research. H.t.C. is stockholder of Coagulation Profile, a spinoff diagnostic company of Maastricht University. B.G. declares no competing interests.

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AXIOMATIC-SSP study: https://www.phri.ca/research/axiomatic-ssp/

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Gigante, B., ten Cate, H. Factor XI inhibitors in patients with cardiovascular disease and a high risk of bleeding: a cautionary tale. Nat Rev Cardiol 20, 511–512 (2023). https://doi.org/10.1038/s41569-023-00872-4

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