Extended treatment with low-dose rivaroxaban provided nearly a three-fold greater reduction in recurrent venous thromboembolism (VTE) than aspirin with a similar rate of bleeding in patients who had completed six to 12 months of anticoagulation, according to results presented by Phil S. Wells, MD, on March 18 at ACC.17 in Washington, DC, and simultaneously published in the New England Journal of Medicine.

EINSTEIN CHOICE is the first study to directly compare low-dose rivaroxaban and aspirin in this population in whom there is equipoise regarding the benefit of continued therapy. The international multicenter study enrolled 3,396 patients (average age 59 years, 45 percent women, 77 percent white). After a median follow-up of 351 days, compared with aspirin (4.4 percent), there was a significant reduction in symptomatic fatal or non-fatal recurrent VTE, with rivaroxaban 10 mg and 20 mg (1.2 percent and 1.5 percent, respectively; p < 0.001).

There was no statistically significant difference in the rates of bleeding between the three treatment groups, which occurred in 0.4 percent of the rivaroxaban 10 mg group, 0.5 percent of the rivaroxaban 20 mg group, and 0.3 percent of the aspirin group. There were no differences between groups for any of the secondary efficacy or safety endpoints.

In patients who suffered a provoked VTE, the rate of a recurrent VTE was lower with both doses of rivaroxaban (0.9 percent and 1.4 percent for the 10 and 20 mg doses) versus aspirin (3.6 percent).

The number needed to treat to prevent one VTE was 30 with the 10 mg dose of rivaroxaban and 33 with the 20 mg dose of rivaroxaban. "Rivaroxaban had significantly greater efficacy in preventing VTE recurrence without significantly increasing risk for major bleeding," Wells said. "Our findings show that it's [a safe option] and appears to be highly protective against potentially life-threatening recurrent VTE."

A follow-up study is planned to explore whether low-dose rivaroxaban is equally effective in other patient populations. Wells noted that the patients enrolled in EINSTEIN CHOICE were younger than the typical patient with VTE, which may limit the generalizability of the study results.

Keywords: ACC17, ACC Annual Scientific Session, Anticoagulants, Aspirin, Double-Blind Method, Embolism, Hemorrhage, Myocardial Infarction, Neoplasms, Random Allocation, Risk Factors, Stroke, Venous Thromboembolism, Venous Thrombosis, ACC Scientific Session Newspaper

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