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- Title
Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies.
- Authors
Prins, Martin H.; Lensing, Anthonie W. A.; Bauersachs, Rupert; Bellen, Bonno; Bounameaux, Henri; Brighton, Timothy A.; Cohen, Alexander T.; Davidson, Bruce L.; Decousus, Hervé; Raskob, Gary E.; Berkowitz, Scott D.; Wells, Philip S.
- Abstract
Background: Standard treatment for venous thromboembolism (VTE) consists of a heparin combined with vitamin K antagonists. Direct oral anticoagulants have been investigated for acute and extended treatment of symptomatic VTE; their use could avoid parenteral treatment and/or laboratory monitoring of anticoagulant effects. Methods: A prespecified pooled analysis of the EINSTEIN-DVT and EINSTEIN-PE studies compared the efficacy and safety of rivaroxaban (15 mg twice-daily for 21 days, followed by 20 mg once-daily) with standard-therapy (enoxaparin 1.0 mg/kg twice-daily and warfarin or acenocoumarol). Patients were treated for 3, 6, or 12 months and followed for suspected recurrent VTE and bleeding. The prespecified noninferiority margin was 1.75. Results: A total of 8282 patients were enrolled; 4151 received rivaroxaban and 4131 received standard-therapy. The primary efficacy outcome occurred in 86 (2.1%) rivaroxaban-treated patients compared with 95 (2.3%) standard-therapy-treated patients (hazard ratio, 0.89; 95% confidence interval [CI], 0.66--1.19; pnoninferiority < 0.001). Major bleeding was observed in 40 (1.0%) and 72 (1.7%) patients in the rivaroxaban and standard-therapy groups, respectively (hazard ratio, 0.54; 95% CI, 0.37-0.79; p = 0.002). In key subgroups, including fragile patients, cancer patients, patients presenting with large clots, and those with a history of recurrent VTE, the efficacy and safety of rivaroxaban were similar compared with standard-therapy. Conclusion: The single-drug approach with rivaroxaban resulted in similar efficacy to standard-therapy and was associated with a significantly lower rate of major bleeding. Efficacy and safety results were consistent among key patient subgroups.
- Subjects
PULMONARY embolism prevention; THROMBOEMBOLISM treatment; THROMBOSIS prevention; CANCER patients; CARDIOVASCULAR diseases; CLINICAL trials; CONFIDENCE intervals; DEMOGRAPHY; ESTROGEN; HEPARIN; PATIENT aftercare; EVALUATION of medical care; MEDICAL needs assessment; VEINS; VITAMIN K; DATA analysis; CONTROL groups; PATIENT selection; DESCRIPTIVE statistics; RIVAROXABAN; THERAPEUTICS
- Publication
Thrombosis Journal, 2013, Vol 11, Issue 1, p21
- ISSN
1477-9560
- Publication type
Article
- DOI
10.1186/1477-9560-11-21