Regulation of Coagulation in Orthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism 4 - RECORD4
The goal of the trial was to evaluate treatment with the direct factor Xa inhibitor rivaroxaban, compared with enoxaparin after total knee arthroplasty.
Rivaroxaban would be noninferior to enoxaparin in preventing deep venous thrombosis (DVT).
Patients Screened: 3,418
Patients Enrolled: 3,148
Mean Follow Up: 17 days
Mean Patient Age: 64 years
- Patients at least 18 years of age undergoing total knee arthroplasty
- Active bleeding or high risk for bleeding
- Contraindication to enoxaparin
- Any condition that would prevent bilateral venography
- Severe liver or renal disease
- Use of drugs that inhibit cytochrome P450
- Pregnancy or breast-feeding
- Planned intermittent pneumatic compression
- Requirement for chronic anticoagulation
- Any DVT, nonfatal PE, or all-cause mortality at 17 days
- Major VTE, nonfatal PE, or death related to VTE
- Major bleeding
- Nonmajor bleeding
- Asymptomatic VTE
- Symptomatic VTE
- Death during the follow-up period
After total knee arthroplasty, patients were randomized to oral rivaroxaban 10 mg daily (n = 1,584) versus subcutaneous enoxaparin 30 mg twice daily (n = 1,564). Rivaroxaban was given 6-8 hours after surgery, while enoxaparin was given 12-24 hours after surgery. Mandatory bilateral venography was performed between 11 and 15 days.
Overall, 3,148 patients were randomized. The mean age was 64 years, 66% were women, mean body mass index was 31 kg/m2, and 58% had regional anesthesia. The mean time from surgery until the study medication was started was 7 hours in the rivaroxaban group and 17 hours in the enoxaparin group. Study drugs were administered for a mean duration of 11.7 days for the rivaroxaban group and 11.0 days for the enoxaparin group.
The primary efficacy outcome, any DVT, nonfatal pulmonary embolism (PE), or all-cause mortality at 17 days occurred in 6.9% of the rivaroxaban group versus 10.1% of the enoxaparin group (p = 0.012).
Major venous thromboembolism (VTE) was 1.2% versus 2.0% (p = 0.12), death was 0.1% versus 0.2% (p = 0.74), PE was 0.3% versus 0.5% (p = 0.53), and major bleeding was 0.7% versus 0.3% (p = 0.11), respectively, for rivaroxaban versus enoxaparin.
Among patients undergoing total knee arthroplasty, the use of oral rivaroxaban is superior to subcutaneous enoxaparin in the prevention of any DVT, nonfatal PE, or all-cause mortality. Major bleeding was nonsignificantly increased in the rivaroxaban group. This study complements earlier RECORD trials. A notable difference is the shorter duration of anticoagulation therapy in the present trial (11-12 days) versus approximately 33 days in RECORD1. Accumulating data from these series of studies indicate that rivaroxaban is a safe and convenient drug to prevent VTE after major orthopedic surgery.
Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009;373:1673-80.
Keywords: Morpholines, Pulmonary Embolism, Thiophenes, Venous Thromboembolism, Orthopedics, Complement System Proteins, Body Mass Index, Enoxaparin, Phlebography, Venous Thrombosis, Factor Xa
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