Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment

Thrombosis Journal

Paolo Prandoni⁵  Jan Beyer-Westendorf⁶  Hervé Decousus⁴  Ákos F Pap²  Dagmar Kubitza²  Martin H Prins¹  Anthonie WA Lensing²  Rupert M Bauersachs³ 

[1] University of Maastricht, Maastricht, the Netherlands;Bayer HealthCare, Wuppertal, Germany;Department of Vascular Medicine, Klinikum Darmstadt GmbH, Grafenstraße 9, 64283, Darmstadt, Germany;Université Jean Monnet, Saint-Etienne, France;Department of Medicine, University of Padua, Padua, Italy;Dresden University Hospital “C.G.Carus”, Dresden, Germany

关键词: Venous thromboembolism;    Rivaroxaban;    Renal insufficiency;    Bleeding;    Anticoagulants;   

Others  :  1135348
DOI  :  10.1186/1477-9560-12-25

 received in 2014-07-21, accepted in 2014-09-14,  发布年份 2014

【 摘 要 】

Background

Patients with renal impairment receiving classical anticoagulation for venous thromboembolism (VTE) are at increased risk of bleeding and possibly pulmonary embolism. We examined the efficacy and safety of oral rivaroxaban in patients with VTE with and without renal impairment.

Methods

Prespecified subgroup analysis of the EINSTEIN DVT and EINSTEIN PE studies comparing fixed-dose rivaroxaban with enoxaparin/a vitamin K antagonist (VKA), performed in 8246 patients enrolled from 2007 to 2011 in 314 hospitals.

Results

Outcomes were recurrent VTE and major or clinically relevant nonmajor bleeding in patients with normal renal function (n = 5569; 67.3%) or mild (n = 2037; 24.6%), moderate (n = 636; 7.7%), or severe (n = 21; 0.3%) renal impairment. Rates of recurrent VTE were 1.8%, 2.8%, 3.3%, and 4.8% in patients with normal renal function and mild, moderate, and severe renal impairment, respectively (p_trend = 0.001). Hazard ratios for recurrent VTE were similar between treatment groups across renal function categories (p_interaction = 0.72). Major bleeding in rivaroxaban recipients occurred in 0.8%, 1.4%, 0.9%, and 0%, respectively (p_trend = 0.50). Respective rates in enoxaparin/VKA recipients were 1.0%, 3.0%, 3.9%, and 9.1% (p_trend < 0.001). Rivaroxaban–enoxaparin/VKA hazard ratios were 0.79 (95% confidence interval [CI] 0.46–1.36) for normal renal function, 0.44 (95% CI 0.24–0.84) for mild renal impairment, and 0.23 (95% CI 0.06–0.81) for moderate renal impairment (p_interaction = 0.034).

Conclusions

Patients with symptomatic VTE and renal impairment are at increased risk of recurrent VTE. Renal impairment increased the risk of major bleeding in enoxaparin/VKA-treated patients but not in rivaroxaban-treated patients.

Trial registration

NCT00440193 and NCT00439777.

【 授权许可】

   
2014 Bauersachs et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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