Abstract | BACKGROUND: METHODS AND RESULTS: A total of 2124 atrial fibrillation patients undergoing percutaneous coronary intervention were randomized to 3 groups: rivaroxaban 15 mg od plus a P2Y12 inhibitor (group 1, n=709); rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (group 2, n=709); and warfarin plus dual antiplatelet therapy (group 3, n=706). Subjects assigned to the VKA group were stratified according to time in therapeutic range and time spent with an INR >3. Kaplan-Meier estimates were calculated for clinically significant bleeding through 1 year and hazard ratios were derived using Cox Proportional Hazards models. Among group 3, 93.4% of the participants had a time in therapeutic range available (mean time in therapeutic range=65.0±24.8%). Both groups 1 and 2 were associated with a reduction in clinically significant bleeding compared with subjects in group 3, regardless of the time in therapeutic range (hazard ratio ranges=0.53-0.71 and 0.57-0.76; respectively, P<0.05 for all). Rivaroxaban strategies were associated with a reduction in clinically significant bleeding compared with VKA regardless of the proportion of time spent with an INR >3 (hazard ratio ranges=0.59-0.67 and 0.42-0.69; P<0.05 for all). CONCLUSIONS: CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01830543.
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Authors | Mathieu Kerneis, Megan K Yee, Roxana Mehran, Tarek Nafee, Christoph Bode, Jonathan L Halperin, Eric D Peterson, Freek W A Verheugt, Peter Wildgoose, Martin van Eickels, Gregory Y H Lip, Marc Cohen, Keith A A Fox, C Michael Gibson |
Journal | Circulation. Cardiovascular interventions
(Circ Cardiovasc Interv)
Vol. 12
Issue 2
Pg. e007124
(02 2019)
ISSN: 1941-7632 [Electronic] United States |
PMID | 30704287
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticoagulants
- Factor Xa Inhibitors
- Platelet Aggregation Inhibitors
- Vitamin K
- Warfarin
- Rivaroxaban
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Topics |
- Aged
- Anticoagulants
(administration & dosage, adverse effects)
- Atrial Fibrillation
(blood, diagnosis, drug therapy)
- Blood Coagulation
(drug effects)
- Coronary Artery Disease
(blood, diagnosis, therapy)
- Factor Xa Inhibitors
(administration & dosage, adverse effects)
- Female
- Hemorrhage
(chemically induced)
- Humans
- International Normalized Ratio
- Male
- Middle Aged
- Percutaneous Coronary Intervention
(adverse effects)
- Platelet Aggregation Inhibitors
(administration & dosage)
- Predictive Value of Tests
- Risk Factors
- Rivaroxaban
(administration & dosage, adverse effects)
- Time Factors
- Treatment Outcome
- Vitamin K
(antagonists & inhibitors)
- Warfarin
(administration & dosage, adverse effects)
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