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Regulation of Coagulation in Orthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism 4 - RECORD4
Description:
The goal of the trial was to evaluate treatment with the direct factor Xa inhibitor rivaroxaban, compared with enoxaparin after total knee arthroplasty.
Hypothesis:
Rivaroxaban would be noninferior to enoxaparin in preventing deep venous thrombosis (DVT).
Study Design
- Randomized
- Blinded
- Parallel
- Stratified
Patients Screened: 3,418
Patients Enrolled: 3,148
Mean Follow Up: 17 days
Mean Patient Age: 64 years
Female: 66%
Patient Populations:
- Patients at least 18 years of age undergoing total knee arthroplasty
Exclusions:
- 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
Primary Endpoints:
- Any DVT, nonfatal PE, or all-cause mortality at 17 days
Secondary Endpoints:
- Major VTE, nonfatal PE, or death related to VTE
- Major bleeding
- Nonmajor bleeding
- Asymptomatic VTE
- Symptomatic VTE
- Death during the follow-up period
Drug/Procedures Used:
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.
Principal Findings:
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.
Interpretation:
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.
References:
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.
Clinical Topics: Anticoagulation Management, Cardiovascular Care Team, Dyslipidemia, Noninvasive Imaging, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and Venothromboembolism, Lipid Metabolism, Novel Agents, Angiography, Nuclear Imaging
Keywords: Morpholines, Pulmonary Embolism, Thiophenes, Venous Thromboembolism, Orthopedics, Complement System Proteins, Body Mass Index, Enoxaparin, Phlebography, Venous Thrombosis, Factor Xa
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