Abstract | BACKGROUND: Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain. METHODS: RESULTS: A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007). CONCLUSIONS:
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Authors | Marc P Bonaca, Rupert M Bauersachs, Sonia S Anand, E Sebastian Debus, Mark R Nehler, Manesh R Patel, Fabrizio Fanelli, Warren H Capell, Lihong Diao, Nicole Jaeger, Connie N Hess, Akos F Pap, John M Kittelson, Ivan Gudz, Lajos Mátyás, Dainis K Krievins, Rafael Diaz, Marianne Brodmann, Eva Muehlhofer, Lloyd P Haskell, Scott D Berkowitz, William R Hiatt |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 382
Issue 21
Pg. 1994-2004
(05 21 2020)
ISSN: 1533-4406 [Electronic] United States |
PMID | 32222135
(Publication Type: 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 |
- Factor Xa Inhibitors
- Platelet Aggregation Inhibitors
- Rivaroxaban
- Aspirin
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Topics |
- Aged
- Aspirin
(adverse effects, therapeutic use)
- Cardiovascular Diseases
(epidemiology, mortality, prevention & control)
- Combined Modality Therapy
- Double-Blind Method
- Drug Therapy, Combination
- Endovascular Procedures
- Factor Xa Inhibitors
(adverse effects, therapeutic use)
- Female
- Hemorrhage
(chemically induced, epidemiology)
- Humans
- Incidence
- Ischemia
(epidemiology, prevention & control)
- Kaplan-Meier Estimate
- Lower Extremity
(blood supply)
- Male
- Middle Aged
- Peripheral Arterial Disease
(drug therapy, surgery)
- Platelet Aggregation Inhibitors
(adverse effects, therapeutic use)
- Rivaroxaban
(adverse effects, therapeutic use)
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