Rivaroxaban has been found to be more efficient than asprin in reducing recurrent venous thromboembolism events, according to recently released results from the EINSTEIN CHOICE trial, published in the New England Journal of Medicine and presented at the American College of Cardiology’s 66th Annual Scientific Session & Expo.
The trial was a multicenter, randomized, double-blind, event driven, superiority study. Researchers worked with 3,396 patients who had been diagnosed with venous thromboembolism and had received anticoagulation treatment for six to twelve months after. The trial compared two doses of rivaroxaban (10 mg or 20 mg daily) with 100 mg of asprin.
The results of the trial report that:
“A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups.”
Rivaroxaban was not only more effective at lowering the patients’ risk of a recurrent event. It also wasn’t accompanied by a “significant increase in bleeding rates,” according to the trial conclusion.
Dr. Philip Stephen Wells, the chair and chief of the Department of Medicine at the University of Ottawa in Canada and a principle investigator on the trial, spoke with The Cardiology Advisor about the results of the trial. He expressed hope that these results will cause medical providers will see the value in prescribing extended therapy for patients with unprovoked VTE and that they will begin to embrace direct oral anticoagulants.
“It's hard to get people to change their practice. But the data are unequivocal at this point in terms of patients with VTE. Recurrent risk of VTE is high in patients with unprovoked VTE and they should be on extended therapy,” Dr. Wells told Britt Gambino, an editor at The Cardiology Advisor. “But now with the DOACs [direct oral anticoagulants], at least 2 of the products, apixaban and rivaroxaban, the bleeding risk is very low and the effectiveness has been maintained. There is no monitoring necessary; they are easy drugs to take.”
For a full look at Dr. Wells’ interview, see “VTE Recurrence Risk Reduced with Rivaroxaban: Q&A With EINSTEIN CHOICE Investigator” In The Cardiology Advisor.