Rivaroxaban demonstrates non-inferiority, halves major bleeding risk
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Rivaroxaban demonstrates noninferiority, halves major bleeding risk Results from the multinational EINSTEIN-PE study show that a fixed-dose regimen of oral rivaroxaban provides a similar level of protection against recurrent venous thromboembolism (VTE) as standard therapy, but may be safer, in terms of the risk of major bleeding. EINSTEIN-PE was a non-inferiority trial in which a total of 4832 patients with acute symptomatic pulmonary embolism, with or without deep-vein thrombosis, were randomised to receive rivaroxaban or standard therapy,* for a mean study duration of approximately 9 months. The primary efficacy outcome was the incidence of symptomatic recurrent VTE, while the primary safety outcome was the incidence of major or clinically relevant non-major bleeding. Results were simultaneously presented at the 61st Annual Scientific Session of the American College of Cardiology (ACC), held in Chicago, Illinois from 24–27 March, and published online in the NEJM. For the primary efficacy outcome, rivaroxaban was non-inferior to standard therapy, with 50 events (2.1%) occurring in the rivaroxaban group compared with 44 events (1.8) in the standard-therapy group (hazard ratio [HR] 1.12; 95% CI 0.75, 1.68). For the primary safety outcome, there was also no significant difference between the groups, with 249 events (10.3%) occurring in the rivaroxaban group compared with 274 (11.4%) in the standard-therapy group (HR 0.90; 0.76, 1.07). However, the number of major bleeding events observed in the rivaroxaban group was half that observed in the standard therapy group (26 events [1.1%] vs 52 events [2.2%]; HR 0.49; 0.31, 0.79). In particular, the rates of intracranial and retroperitoneal bleeding were substantially lower with rivaroxaban. * enoxaparin + warfarin, acenocoumarol The EINSTEIN-PE Investigators. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism. New England Journal of Medicine : [11 pages], 26 Mar 2012. Available from: URL: http://www.nejm.org/doi/pdf/10.1056/ 803068713 nejmoa1113572
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