A pooled analysis of the EIN-STEIN-DVT and EINSTEIN-PE studies showed rivaroxaban to be as effective in preventing recurrences of venous thromboembolism as enoxaparin followed by a vitamin-K antagonist, with perhaps less risk for bleeding. Subgroup analyses found the drug to be safe and effective in specific high-risk populations, such as elderly fragile patients and patients with cancer or large clots. The studies had noninferiority designs and compared oral rivaroxaban (15 mg twice daily for 3 weeks, then 20 mg once daily for up to 12 months) with enoxaparin for 5 to 10 days followed by an oral vitamin-K antagonist.
Among the 8282 patients enrolled in the 2 trials, thromboembolism recurred in 2.1% receiving rivaroxaban and 2.3% receiving enoxaparin/vitamin-K antagonist; major or nonmajor clinically relevant bleeding was observed in 9.4% and 10.0%, and major bleeding in 1.0% and 1.7%, respectively. In patients with cancer, recurrence was observed in 2.6% and 4.0%, and major bleeding in 2.6% and 4.1%, respectively.
Reference
Buller HR. Oral rivaroxaban for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN DVT and EINSTEIN PE studies. Presented at: 54th American Society of Hematology Annual Meeting; December 8-11, 2012; Atlanta, GA. Abstract 20.
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