Extended-Use Rivaroxaban Effectively Prevents Venous Thromboembolism After Hip Surgery

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Title: Extended-Use Rivaroxaban Effectively Prevents Venous Thromboembolism After Hip Surgery
URL: http://www.pslgroup.com/dg/2244AA.htm
Doctor's Guide
June 25, 2008

NEW YORK -- June 25, 2008 -- Use of extended duration rivaroxaban is more effective at preventing venous thromboembolism (VTE) after total hip arthroplasty (THA) compared with short-term enoxaparin plus placebo, according to a randomised, controlled study published early online in an upcoming edition of The Lancet.

The risk of VTE is high after THA and can persist after hospital discharge. Consensus guidelines recommend heparin-based thromboprophylaxis in such patients for a minimum of 10 days, and up to 35 days after surgery, as this prevents the risk of clots. However, this preventive treatment is not used much once the patient leaves hospital, with 1 prospective registry suggesting that less than 50% of patients receive it for at least 28 days.

Ajay Kakkar, MD, Barts and the London School of Medicine and Dentistry, and the Thrombosis Research Institute, London, United Kingdom, and colleagues, did the Regulation of Coagulation in Major Orthopedic Surgery Reducing the Risk of DVT (deep-vein thrombosis) and PE (pulmonary embolism) (RECORD2) study to address this challenge with a new orally active antithrombotic drug. Their aim was to compare the use of rivaroxaban, used for 31 to 39 days, with enoxaparin for 10 to 14 days followed by placebo in patients undergoing THA.

The study included 2,509 patients scheduled for THA. Patients were randomly assigned to receive oral rivaroxaban 10 mg QD for 31 to 39 days, followed by a placebo injection for 10 to 14 days (n = 1,252) or enoxaparin 40 mg QD subcutaneously for 10 to14 days with placebo tablet for 31 to 39 days (n = 1,257). The measured endpoint of the trial was a combination of DVT, non-fatal pulmonary embolism (NFPE), and all-cause mortality up to days 30 to 42.

The researchers completed their analysis on 864 patients in the rivaroxaban group and 869 in the enoxaparin group. The primary outcome occurred in 17 patients (2.0%) in the rivaroxaban group and in 81 patients (9.3%) in the enoxaparin group, resulting in an absolute risk reduction of 7.3% for the rivaroxaban group. Therefore, patients in the enoxaparin group were more than 4 times as likely to suffer DVT, NFPE, or die, compared with patients in the rivaroxaban group. Bleeding events during treatment were similar for both groups.

"Extended thromboprophylaxis with rivaroxaban was significantly more effective than short-term enoxaparin plus placebo for the prevention of venous thromboembolism, including symptomatic events, in patients undergoing total hip arthroplasty," the authors wrote.

SOURCE: The Lancet

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