Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial.
Abstract | Importance: Objective: To examine whether low-dose rivaroxaban was associated with reduced thromboembolic events in patients enrolled in the COMMANDER HF trial. Design, Setting, and Participants: Post hoc analysis of the COMMANDER HF multicenter, randomized, double-blind, placebo-controlled trial in patients with CAD and worsening HF. The trial randomized 5022 patients postdischarge from a hospital or outpatient clinic after treatment for worsening HF between September 2013 and October 2017. Patients were required to be receiving standard care for HF and CAD and were excluded for a medical condition requiring anticoagulation or a bleeding history. Patients were randomized in a 1:1 ratio. Analysis was conducted from June 2018 and January 2019. Intervention: Patients were randomly assigned to receive 2.5 mg of rivaroxaban given orally twice daily or placebo in addition to their standard therapy. Main Outcomes and Measures: Results: Of 5022 patients, 3872 (77.1%) were men, and the overall mean (SD) age was 66.4 (10.2) years. Over a median (interquartile range) follow-up of 19.6 (11.7-30.8) months, fewer patients assigned to rivaroxaban compared with placebo had a thromboembolic event including sudden/unwitnessed deaths: 328 (13.1%) vs 390 (15.5%) (hazard ratio, 0.83; 95% CI, 0.72-0.96; P = .01). When sudden/unwitnessed deaths were excluded, the results analyzing thromboembolic events were similar: 153 (6.1%) vs 190 patients (7.6%) with an event (hazard ratio, 0.80; 95% CI, 0.64-0.98; P = .04). Conclusions and Relevance: In this study, thromboembolic events occurred frequently in patients with HF, CAD, and sinus rhythm. Rivaroxaban may reduce the risk of thromboembolic events in this population, but these events are not the major cause of morbidity and mortality in patients with recent worsening of HF for which rivaroxaban had no effect. While consistent with other studies, these results require confirmation in prospective randomized clinical trials. Trial Registration: ClinicalTrials.gov identifier: NCT01877915.
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Authors | Barry Greenberg, James D Neaton, Stefan D Anker, William M Byra, John G F Cleland, Hsiaowei Deng, Min Fu, David A La Police, Carolyn S P Lam, Mandeep R Mehra, Christopher C Nessel, Theodore E Spiro, Dirk J van Veldhuisen, Catherine M Vanden Boom, Faiez Zannad |
Journal | JAMA cardiology
(JAMA Cardiol)
Vol. 4
Issue 6
Pg. 515-523
(06 01 2019)
ISSN: 2380-6591 [Electronic] United States |
PMID | 31017637
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Factor Xa Inhibitors
- Platelet Aggregation Inhibitors
- Thienopyridines
- Rivaroxaban
- Aspirin
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Topics |
- Aged
- Aspirin
(therapeutic use)
- Chronic Disease
- Coronary Artery Disease
(drug therapy)
- Death, Sudden
(epidemiology)
- Disease Progression
- Double-Blind Method
- Drug Therapy, Combination
- Factor Xa Inhibitors
(therapeutic use)
- Female
- Heart Failure
(drug therapy, physiopathology)
- Humans
- Male
- Middle Aged
- Mortality
- Myocardial Infarction
(epidemiology)
- Platelet Aggregation Inhibitors
(therapeutic use)
- Proportional Hazards Models
- Pulmonary Embolism
(epidemiology)
- Rivaroxaban
(therapeutic use)
- Stroke
(epidemiology)
- Stroke Volume
- Thienopyridines
(therapeutic use)
- Thromboembolism
(epidemiology)
- Venous Thrombosis
(epidemiology)
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