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Phase 3 data show rivaroxaban superior to enoxaparin in preventing post-THA VTE

Patients in both treatment groups demonstrated a similar rate of major and non-major bleeding.

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A phase 3 trial found that the investigational anticoagulant rivaroxaban was statistically superior to the subcutaneous administration of enoxaparin for preventing venous thromboembolism in patients who underwent total hip arthroplasty, according to a press release announcing the study results.

Data from the RECORD1 (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and pulmonary embolism) study show that rivaroxaban demonstrated a 70% relative risk reduction (RRR; P<.001) in total venous thromboembolism (VTE) when compared with enoxaparin [Lovenox, Sanofi Aventis], and an 88% RRR (P<.001) in major VTE, the release said.

In addition, patients treated with rivaroxaban demonstrated a similar rate of both major and non-major bleeding compared to enoxaparin.

Major bleeding occurred in 0.3% of rivaroxaban-treated patients and in 0.1% of enoxaparin-treated patients. Non-major bleeding occurred in 5.8% of both groups, according to the press release from Johnson & Johnson Pharmaceutical Research & Development LLC, which is jointly developing the drug with Bayer HealthCare AG.

Rivaroxaban is an oral, once-daily direct factor Xa inhibitor.

Bengt Eriksson, MD, an orthopedic surgeon at the Sahlgrenska University Hospital/Ostra in Gothenburg, Sweden, presented the data at the American Society of Hematology annual meeting. Eriksson is the principal investigator for the RECORD1 clinical trial.

The RECORD1 clinical trial evaluated the safety and efficacy of rivaroxaban compared to enoxaparin in 4,541 patients undergoing THA. Patients in both groups received thromboprophylaxis for 5 weeks.

The primary endpoint was total VTE — a composite of deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all-cause mortality. The main secondary endpoint was major VTE, a composite of proximal DVT, non-fatal PE and VTE-related death, the release said.

For more information:

• Eriksson BI, Borris LC, Friedman RJ, et al. Oral rivaroxaban compared with subcutaneous enoxaparin for extended thromboprophylaxis after total hip arthroplasty: The RECORD1 trial. #6. Presented at the American Society of Hematology 49th Annual Meeting. Dec. 8-11, 2007. Atlanta.