Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment
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ORIGINAL BASIC RESEARCH
Open Access
Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment Rupert M Bauersachs1*, Anthonie WA Lensing2, Martin H Prins3, Dagmar Kubitza2, Ákos F Pap2, Hervé Decousus4, Jan Beyer-Westendorf5 and Paolo Prandoni6
Abstract 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 (ptrend = 0.001). Hazard ratios for recurrent VTE were similar between treatment groups across renal function categories (pinteraction = 0.72). Major bleeding in rivaroxaban recipients occurred in 0.8%, 1.4%, 0.9%, and 0%, respectively (ptrend = 0.50). Respective rates in enoxaparin/VKA recipients were 1.0%, 3.0%, 3.9%, and 9.1% (ptrend < 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 (pinteraction = 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. Keywords: Anticoagulants, Bleeding, Renal insufficiency, Rivaroxaban, Venous thromboembolism
Background Rivaroxaban is an oral, direct Factor Xa inhibitor with predictable pharmacokinetic and pharmacodynamic properties, which obviate the need for routine coagulation monitoring, and a rapid onset of action, with a peak anticoagulant effect within 2 to 4 h after dosing [1,2]. Pharmacokinetic studies showed that rivaroxaban has a dual mode of elimination; approximately two-thirds of * Correspondence: [email protected] 1 Department of Vascular Medicine, Klinikum Darmstadt GmbH, Grafenstraße 9, 64283, Darmstadt, Germany Full list of author information is available at the end of the article
orally administered rivaroxaban is inactivated by metabolic degradation, of which half is eliminated renally and the other half eliminated by the hepatobiliary route. The final one-third of the administered dose undergoes renal excreti
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