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Prins MH, Lensing AW, Bauersachs R, et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11(1):21doi: 10.1186/1477-9560-11-21.
Prins, M. H., Lensing, A. W., Bauersachs, R., van Bellen, B., Bounameaux, H., Brighton, T. A., Cohen, A. T., Davidson, B. L., Decousus, H., Raskob, G. E., Berkowitz, S. D., Wells, P. S. (2013). Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thrombosis journal, 11(1), 21. https://doi.org/10.1186/1477-9560-11-21
Prins, Martin H, et al. "Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies." Thrombosis journal vol. 11,1 (2013): 21. doi: https://doi.org/10.1186/1477-9560-11-21
Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21. PMID: 24053656; PMCID: PMC3850944.
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Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21.

Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies.

Thrombosis journal

Martin H Prins, Anthonie Wa Lensing, Rupert Bauersachs, Bonno van Bellen, Henri Bounameaux, Timothy A Brighton, Alexander T Cohen, Bruce L Davidson, Hervé Decousus, Gary E Raskob, Scott D Berkowitz, Philip S Wells,

Affiliations

  1. Maastricht University Medical Center, Maastricht, The Netherlands. [email protected].

PMID: 24053656 PMCID: PMC3850944 DOI: 10.1186/1477-9560-11-21

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.

TRIAL REGISTRATION EINSTEIN-PE: ClinicalTrials.gov, NCT00439777; EINSTEIN-DVT: ClinicalTrials.gov, NCT00440193.

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