Results from the Phase III EINSTEIN CHOICE study presented at the American College of Cardiology (ACC) annual scientific session demonstrated that extended use of Johnson & Johnson and Bayer's anticoagulant Xarelto (rivaroxaban) led to significantly fewer recurrent blood clots and similar rates of major bleeding compared to aspirin in patients with venous thromboembolism (VTE). "In addition to confirming findings from previous studies…EINSTEIN CHOICE provides valuable clinical insights on the superiority of Xarelto to aspirin, as well as the potential extended use of a lower dose of Xarelto for continued venous protection," said Paul Burton, vice president of medical affairs Johnson & Johnson's Janssen Pharmaceuticals unit, adding "we look forward to discussing these important data with the FDA."

In the study, 3396 patients with VTE who had completed six months to 12 months of anticoagulation therapy were randomly assigned once-daily Xarelto at doses of either 10 mg or 20 mg, or once-daily aspirin for up to 12 months. Johnson & Johnson noted that patients who required extended anticoagulation at therapeutic doses were not included in the study, "as the objective…was to investigate those patients for whom the treating physician was uncertain about the need for continuing anticoagulant therapy." The primary efficacy outcome was symptomatic recurrent fatal or nonfatal VTE, and the principal safety outcome was major bleeding. 

Results, which were also published in the NEJM, showed that the rate of recurrent VTE was 1.2 percent in the 10-mg Xarelto group and 1.5 percent in the 20-mg group, compared with 4.4 percent among those given aspirin. Fatal VTE occurred in 0 percent, 0.2 percent and 0.2 percent, respectively. Meanwhile, according to study data, rates of major bleeding were 0.4 percent in the group receiving 10 mg of Xarelto, 0.5 percent in the Xarelto higher-dose group, and 0.3 percent for aspirin. The study authors noted that the incidence of adverse events was similar across all three groups. 

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"Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with Xarelto at either a treatment dose of 20 mg or a prophylactic dose of 10 mg, than with aspirin, without a significant increase in bleeding rates," the authors concluded. Principal investigator Jeffrey Weitz remarked that the EINSTEIN CHOICE study "demonstrates no role for aspirin in VTE, which should change practice." Weitz noted that, if approved, the 10-mg dose of Xarelto "will be available to physicians as an additional choice in their armamentarium against recurrent VTE alongside the already approved 20-mg once-daily dose." He suggested this "flexibility...will then enable physicians to use a precision approach to selecting the most appropriate extended treatment based on assessment of individual patient characteristics." 

Xarelto, which is marketed in the US by Johnson & Johnson and outside the country by Bayer, is approved in more than 130 countries across multiple indications, including prevention of VTE in adults undergoing hip or knee replacement surgery. The drug is also approved in adults to treat pulmonary embolism (PE) and deep vein thrombosis (DVT), as well as to prevent recurrent PE and DVT. Further, Xarelto is cleared for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors.