RECORD1
Trial question
What is the effect of rivaroxaban for extended thromboprophylaxis in patients undergoing total hip arthroplasty?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 4433
4433 patients (2462 female, 1971 male).
Inclusion criteria: patients undergoing total hip arthroplasty.
Key exclusion criteria: bilateral hip arthroplasty; pregnancy or lactation; active bleeding or a high risk of bleeding; contraindications for prophylaxis with enoxaparin or a condition that might require an adjusted dose of enoxaparin; substantial liver disease; severe renal impairment.
Interventions
N=2209 rivaroxaban (10 mg PO once daily).
N=2224 enoxaparin (40 mg SC once daily).
Primary outcome
Deep vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 36 days
1.1%
3.7%
3.7 %
2.8 %
1.9 %
0.9 %
0.0 %
Rivaroxaban
Enoxaparin
Significant
decrease ▼
NNT = 38
Significant decrease in DVT, nonfatal PE, or death from any cause at 36 days (1.1% vs. 3.7%; AD -2.6%, 95% CI -3.7 to -1.5).
Secondary outcomes
Significant decrease in major VTE (0.2% vs. 2%; AD -1.7%, 95% CI -2.5 to -1).
Significant decrease in DVT (0.8% vs. 3.4%; AD -2.7%, 95% CI -1.2 to -2.7).
Safety outcomes
No significant differences in major bleeding (0.3% vs. 0.1%, p=0.18).
Conclusion
In patients undergoing total hip arthroplasty, rivaroxaban was superior to enoxaparin with respect to DVT, nonfatal PE, or death from any cause at 36 days.
Reference
Eriksson BI, Borris LC, Friedman RJ et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75.
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