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

被引：384

作者：

Prins M.H. ^{[1
]}

Lensing A.W.A. ^{[2
]}

Bauersachs R. ^{[3
]}

van Bellen B. ^{[4
]}

Bounameaux H. ^{[5
]}

Brighton T.A. ^{[6
]}

Cohen A.T. ^{[7
]}

Davidson B.L. ^{[8
]}

Decousus H. ^{[9
]}

Raskob G.E. ^{[10
]}

Berkowitz S.D. ^{[11
]}

Wells P.S. ^{[12
]}

机构：

[1] Maastricht University Medical Center, Maastricht

[2] Bayer HealthCare AG, Wuppertal

[3] Klinikum Darmstadt, Darmstadt

[4] Hospital Beneficência Portuguesa, São Paulo

[5] Department of Medicine, University Hospitals of Geneva, Faculty of Medicine, Geneva

[6] Department of Haematology, Prince of Wales Hospital, Sydney, NSW

[7] Department of Haematological Medicine, King's College Hospital, London

[8] University of Washington School of Medicine, Seattle, WA

[9] Service de Médecine et Thérapeutique, CHU Saint-Etienne, Saint-Etienne

[10] University of Oklahoma Health Sciences Center, College of Public Health, Oklahoma City, OK

[11] Bayer HealthCare Pharmaceuticals, Whippany, NJ

[12] Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, Ontario

来源：

Thrombosis Journal | / 11卷 / 1期

关键词：

Randomized controlled trials; Rivaroxaban; Standard therapy; Venous thromboembolism;

D O I：

10.1186/1477-9560-11-21

中图分类号：

学科分类号：

摘要：

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. © 2013 Prins et al.; licensee BioMed Central Ltd.

引用

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