Abstract | BACKGROUND: METHODS: RESULTS: Among the patients receiving milvexian twice daily, venous thromboembolism developed in 27 of 129 (21%) taking 25 mg, in 14 of 124 (11%) taking 50 mg, in 12 of 134 (9%) taking 100 mg, and in 10 of 131 (8%) taking 200 mg. Among those receiving milvexian once daily, venous thromboembolism developed in 7 of 28 (25%) taking 25 mg, in 30 of 127 (24%) taking 50 mg, and in 8 of 123 (7%) taking 200 mg, as compared with 54 of 252 patients (21%) taking enoxaparin. The dose-response relationship with twice-daily milvexian was significant (one-sided P<0.001), and the 12% incidence of venous thromboembolism with twice-daily milvexian was significantly lower than the prespecified benchmark of 30% (one-sided P<0.001). Bleeding of any severity occurred in 38 of 923 patients (4%) taking milvexian and in 12 of 296 patients (4%) taking enoxaparin; major or clinically relevant nonmajor bleeding occurred in 1% and 2%, respectively; and serious adverse events were reported in 2% and 4%, respectively. CONCLUSIONS:
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Authors | Jeffrey I Weitz, John Strony, Walter Ageno, David Gailani, Elaine M Hylek, Michael R Lassen, Kenneth W Mahaffey, Ravi S Notani, Robin Roberts, Annelise Segers, Gary E Raskob, AXIOMATIC-TKR Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 385
Issue 23
Pg. 2161-2172
(12 02 2021)
ISSN: 1533-4406 [Electronic] United States |
PMID | 34780683
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 Massachusetts Medical Society. |
Chemical References |
- Anticoagulants
- Enoxaparin
- Pyrimidines
- Triazoles
- milvexian
- Factor XIa
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Topics |
- Administration, Oral
- Aged
- Aged, 80 and over
- Anticoagulants
(adverse effects, therapeutic use)
- Arthroplasty, Replacement, Knee
- Dose-Response Relationship, Drug
- Enoxaparin
(adverse effects, therapeutic use)
- Factor XIa
(antagonists & inhibitors)
- Female
- Humans
- Male
- Middle Aged
- Postoperative Complications
(prevention & control)
- Pyrimidines
(administration & dosage, adverse effects, therapeutic use)
- Triazoles
(administration & dosage, adverse effects, therapeutic use)
- Venous Thromboembolism
(prevention & control)
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