Xarelto Reduces VTE Recurrence Compared to Aspirin

During a presentation at the American College of Cardiology’s 2017 Annual Scientific Session, researchers showed that a low dose of Xarelto (rivaroxaban; Janssen) significantly reduced the risk of venous thromboembolism (VTE) in patients at high risk for a recurrence of blood clots, compared to use of aspirin alone. The study was also published in the New England Journal of Medicine. 

“We have shown that practitioners can safely prescribe rivaroxaban for patients at risk for a recurrent VTE without being concerned that doing so will increase risk for bleeding side effects,” Philip S Wells, MD, chief of the department of medicine at the University of Ottawa, and a lead researcher on the study, said in a press release. 

“Although many patients with VTE require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin,” the authors wrote.

During the EINSTEIN CHOICE study, researchers studied 3396 patients who had completed 6 to 12 months of anticoagulant therapy for a VTE, in order to determine the effectiveness of Xarelto vs aspirin. Dr Wells and colleagues classified study participants into three groups: a group that received 10 mg of Xarelto, a group that received 20 mg of Xarelto, and a group that received
100 mg of aspirin. Participants received medications once daily for up to 12 months. 

“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,” Dr Wells said in the press release. “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.”

Study results showed that 1.2% of patients in the 10-mg Xarelto group experienced a reoccurrence of VTE, 1.5% of patients in the 20-mg Xarelto group had VTE, and 4.4% of patients in the aspirin group experienced VTE. The
researchers noted that this difference was statistically significant for both Xarelto groups when compared to the aspirin group. 

Furthermore, study results showed that incidences of recurrent VTE, heart attack, ischemic stroke, systemic embolism, or venous thrombosis occurred in 1.9% of study patients in the
10-mg group and 2% of study patients in the
20-mg group compared to 5.6% in the aspirin group.

Researchers also noted that the primary endpoint results related to VTE remained relevant when looking at prespecified study subgroups.

Additionally, Dr Wells and colleagues noted that there were no significant efficacy or safety differences noted between the two Xarelto groups. Likewise, they found that there were not significant differences in the rate of
adverse events among study participants in all three study groups.

“Rivaroxaban had significantly greater efficacy in preventing VTE recurrence without significantly increasing risk for major bleeding,” Dr Wells said. “Our findings show that it’s [a safe option] and appears to be highly protective against potentially life-threatening recurrent VTE.” —David Costill