News Release

Extended use of rivaroxaban extremely effective at preventing VTE after hip surgery (RECORD2 trial)

Peer-Reviewed Publication

The Lancet_DELETED

Use of extended duration rivaroxaban is significantly more effective at preventing venous thromboembolism after total hip arthroplasty (complete hip replacement surgery) (THA) compared with short-term enoxaparin plus placebo. This is the conclusion of authors of an Article published early Online and in an upcoming edition of The Lancet.

The risk of venous thromboembolism (VTE) -- a blood clot which can be fatal -- is high after THA and can persist after hospital discharge. Consensus guidelines recommend heparin-based thromboprophylaxis (eg, with enoxaparin) in such patients for a minimum of 10 days, and up to 35 days, after surgery, as this prevents the risk of clots. However such preventive treatment is not used much once the patient leaves hospital, with one prospective registry suggesting less than 50% of patients receive it for at least 28 days. Professor Ajay Kakkar, Barts and the London School of Medicine and Dentistry, and the Thrombosis Research Institute, London, UK, and colleagues did the RECORD2 study to address this challenge with a new orally active antithrombotic drug. Their aim was to compare the use of the oral antithrombotic drug rivaroxaban, used for 31-39 days, with enoxaparin for 10-14 days followed by placebo in patients undergoing THA.

In this randomised, controlled trial 2509 patients scheduled for THA were randomly assigned to receive oral rivaroxaban 10mg once daily for 31-39 days (with placebo injection for 10-14 days, 1252 patients) or enoxaparin 40mg once daily subcutaneously for 10-14 days (with placebo tablet for 31-39 days, 1257 patients). The measured endpoint of the trial was a combination of deep-vein thrombosis (DVT), non-fatal pulmonary embolism (NFPE), and all-cause mortality up to days 30-42.

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, an absolute risk reduction of 7.3% for the rivaroxaban group. Thus patients in the enoxaparin group were more than four times as likely to suffer DVT, NFPE, or die than those in the rivaroxaban group. Bleeding events during treatment were similar for both groups.

The authors conclude: "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."

In an accompanying Comment, Dr John Eikelboom and Professor Jeffrey Weitz, McMaster University, Hamilton, ON, Canada, say: "With superior efficacy, no compromise in safety, and a convenient once daily regimen, rivaroxaban seems an obvious choice for simplified thromboprophylaxis after hip or knee arthroplasty."

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Professor Ajay Kakkar, Barts and the London School of Medicine and Dentistry, and the Thrombosis Research Institute, London, UK T) + 44 (0) 20 7351 8309 E) akkakkar@tri-london.ac.uk

Alternative contact Alex Fernandes, Press Office T) +44 (0)20 7882 7910 E) a.fernandes@qmul.ac.uk

Dr John Eikelboom, McMaster University, Hamilton, ON, Canada T) +1 905 527 4322 ext 44768 E) eikelbj@mcmaster.ca

http://www.eurekalert.org/jrnls/lance/pdfs/rivaroxabanfinal.pdf


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