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New oral Factor Xa inhibitor shows significant reduction in VTE after TKA
The investigators found no evidence of compromised liver function from the anticoagulant.
The results of a new phase 3 clinical trial show that rivaroxaban is significantly more effective than enoxaparin in reducing the risk of total venous thromboembolism after total knee arthroplasty.
The research also indicates that rivaroxaban (Xarelto, Bayer HealthCare/Johnson & Johnson), an oral, direct Factor Xa inhibitor, has a safety profile similar to enoxaparin (Lovenox, Sanofi-Aventis).
To investigate the safety and efficacy of rivaroxaban in the prevention of venous thromboembolism (VTE) after total knee arthroplasty, investigators randomized 2,531 patients to receive a once-daily dose of either 10 mg rivaroxaban or 40 mg subcutaneous enoxaparin.
Patients in the rivaroxaban group received their dose at 6 to 8 hours postop, while the enoxaparin-treated group received their dose 12 hours before surgery. Both groups continued their thromboprophylactic regimen for 10 to 14 days.
The investigators discovered a 9.6% rate of total VTE, including any deep venous thrombosis (DVT), non-fatal pulmonary embolism and all-cause mortality in the rivaroxaban group compared to 18.9% for the enoxaparin group. An analysis of major VTE, which included proximal DVT, non-fatal pulmonary embolism (PE) and VTE-related death, also revealed a significantly lower rate in the rivaroxaban group compared to the enoxaparin cohort (1% vs. 2.6%).
In addition, a review of symptomatic VTE events including symptomatic non-fatal or fatal PE and any symptomatic DVT, showed a 0.7% rate for rivaroxaban-treated patients compared to 2% for the enoxaparin group.
“Rivaroxaban, 10 mg given once daily, significantly reduced VTE, major VTE and symptomatic VTE without increasing bleeding risk,” said Michael R. Lassen, MD, the lead investigator of the multicenter, double-blind trial. “It was well tolerated in all the patients. There was no evidence of comprised liver function attributed to either of the regimens. There was also no increase in hemorrhagic wound complications or wound-related infections [with rivaroxaban].”
Lassen presented results of the Regulation of Coagulation in Major Orthopaedic surgery reducing the Risk of DVT and PE (RECORD3) trial at the 9th European Federation of National Associations of Orthopaedics and Traumatology Congress in Nice.
“For the first time, we were able to show a clinical dramatic VTE reduction when you are given a direct Factor-Xa inhibitor, as rivaroxaban, compared to the standard practice of low-molecular-weight-heparin,” Lassen said. “And there was no price to be paid in terms of major bleeding or any bleeds.”
For more information:
- Michael R. Lassen, MD, can be reached at Hørsholm Hospital, Spine Clinic, Clinical Trial Unit Usserød Kongevej 102, DK-2970 Hørsholm, Denmark; +45-48-29-2778; e-mail: mirula@noh.regionh.dk. He received honoraria from Bayer HealthCare as a member of the RECORD3 steering committee and consulting fees from Bayer HealthCare. He also receives advisory board fees from Bayer HealthCare and consulting fees from Sanofi-Aventis. Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development supported the research.
Reference:
- Lassen MR, Ageno W, Bandel T, et al. Rivaroxaban for thromboprophylaxis after total knee replacement: the RECORD3 trial. Paper F3. Presented at the 9th European Federation of National Associations of Orthopaedics and Traumatology Congress. May 29-June 1, 2008. Nice.