Janssen Pharmaceuticals has announced new phase 3 results from EINSTEIN CHOICE showing patients with venous thromboembolism (VTE) taking Xarelto (rivaroxaban), who received either 10 mg or 20 mg once daily over an extended time period, had significantly fewer recurrent blood clots and similar rates of major bleeding compared to those taking aspirin 100 mg once daily. Specifically, Xarelto 10 mg reduced the risk of recurrent VTE by 74 percent and Xarelto 20 mg by 66 percent.
These findings were presented today during a Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials session at the American College of Cardiology's 66th Annual Scientific Session (ACC.17) and published simultaneously in The New England Journal of Medicine. EINSTEIN CHOICE is part of the industry-leading EXPLORER clinical research programme for Xarelto, a collaborative effort between Janssen and its development partner, Bayer.
VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects more than 900,000 Americans each year; one-third of these occurrences are fatal.i As all people with VTE are at risk of having another occurrence, guidelines currently recommend anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like Xarelto, for three months or longer.ii
Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years.iii In people who decide to stop anticoagulant therapy, guidelines currently suggest using aspirin for long-term prevention of recurrent VTE rather than no aspirin at all.ii The EINSTEIN CHOICE study was designed to compare the efficacy and safety of XARELTO to aspirin for continued VTE management.
"How best to extend anticoagulant use beyond the initial treatment window has been a constant source of debate, with physicians carefully balancing patients' risk of another VTE with the risk of anticoagulant-related bleeding," said study investigator Philip S. Wells, MD, Professor, Chair and Chief, Department of Medicine, University of Ottawa, and Senior Scientist, The Ottawa Hospital, Ontario, Canada. "With EINSTEIN CHOICE, for the first time we have clinical evidence confirming rivaroxaban is superior to aspirin in reducing recurrent VTE, with no significant impact on safety. These important results have the potential to trigger a paradigm shift in how physicians manage their patients and protect them from VTE recurrence over the long term."
"In addition to confirming findings from previous studies examining the long-term use of XARELTO in VTE, 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, MD, PhD, FACC, vice president, medical affairs, Janssen. "We look forward to discussing these important data with the US Food and Drug Administration."