Abstract | BACKGROUND: METHODS: This was a multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding. RESULTS: Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60). CONCLUSIONS:
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Authors | Giancarlo Agnelli, Cecilia Becattini, Guy Meyer, Andres Muñoz, Menno V Huisman, Jean M Connors, Alexander Cohen, Rupert Bauersachs, Benjamin Brenner, Adam Torbicki, Maria R Sueiro, Catherine Lambert, Gualberto Gussoni, Mauro Campanini, Andrea Fontanella, Giorgio Vescovo, Melina Verso, Caravaggio Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 382
Issue 17
Pg. 1599-1607
(04 23 2020)
ISSN: 1533-4406 [Electronic] United States |
PMID | 32223112
(Publication Type: Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020 Massachusetts Medical Society. |
Chemical References |
- Anticoagulants
- Pyrazoles
- Pyridones
- apixaban
- Dalteparin
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Topics |
- Administration, Oral
- Aged
- Anticoagulants
(administration & dosage, adverse effects)
- Dalteparin
(administration & dosage, adverse effects)
- Female
- Hemorrhage
(chemically induced, epidemiology)
- Humans
- Incidence
- Injections, Subcutaneous
- Intention to Treat Analysis
- Male
- Middle Aged
- Neoplasms
(complications, mortality)
- Proportional Hazards Models
- Pulmonary Embolism
(prevention & control)
- Pyrazoles
(administration & dosage, adverse effects)
- Pyridones
(administration & dosage, adverse effects)
- Secondary Prevention
(methods)
- Single-Blind Method
- Venous Thromboembolism
(drug therapy, etiology, prevention & control)
- Venous Thrombosis
(prevention & control)
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