Anticoagulant Rivaroxaban Effective for VTE Prevention in RECORD3 Trial. July 9, 2007
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July 9, 2007 By Sabina A. Murphy, M.P.H. [1]
Geneva, Switzerland: The RECORD3 study showed that the anticoagulant rivaroxaban, a novel direct Factor Xa inhibitor, reduced deep vein thrombosis in patients undergoing total knee replacement surgery as compared with enoxaparin, without an increase in bleeding. The phase III trial results were presented today by Dr. Michael R. Lassen at the XXI International Society on Thrombosis and Haemostasis.
The study was a randomized trial of once-daily, oral 10 mg rivaroxaban compared with 40 mg enoxaparin in 2,531 patients undergoing total knee replacement surgery. The primary endpoint of deep vein thrombosis, pulmonary embolism, or death at 30 days occurred less in the rivaroxaban group than the enoxaparin group (9.6% vs. 18.9%, RRR 49%; p < 0.001). Major VTE was also reduced with rivaroxaban (1.0% vs. 2.6%, RRR 62%; p = 0.01), as was symptomatic VTE (1.0% vs. 2.7%, p = 0.006). Major bleeding, the primary safety endpoint, did not differ between groups (0.6% vs. 0.5%, p = 0.77), nor did liver function abnormalities.
RECORD3 is part of a 4-trial RECORD program of DVT prevention with rivaroxaban compared with enoxaparin in approximately 11,500 patients undergoing orthopedic surgery. Rivaroxaban is also being studied in patients with acute coronary syndromes in the ATLAS ACS-TIMI 46 trial and in patients with atrial fibrillation in the ROCKET trial.
Michael R. Lassen, MD (Hoersholm Hospital, University of Copenhagen, Denmark), the lead investigator and presenter of the trial, stated “The RECORD3 results are exciting, as they indicate that rivaroxaban may better meet the needs of many patients undergoing orthopedic surgery. It’s an important step for this category that a once-daily, oral medication has demonstrated better efficacy in preventing VTE than the current standard of care, while also displaying a promising safety profile.”
"What is impressive is the fact that this was not just a reduction in DVT on venography, but the first major trial to show a reduction in symptomatic VTE" stated C. Michael Gibson, M.S., M.D. [2] Principal investigator of the ongoing ATLAS ACS trial.
The trial was funded by Johnson & Johnson Pharmaceutical Research & Development and Bayer HealthCare AG.
Dr. Lassen and Gibson have received research grant support from Johnson & Johnson Pharmaceutical Research & Development and Bayer HealthCare AG.
