Trial halted amid safety concerns for rivaroxaban after TAVR

The GALILEO trial has been stopped after an early look at outcomes revealed rivaroxaban was associated with greater odds of thromboembolic events, all-cause death and bleeding events compared to antiplatelet therapy following transcatheter aortic valve replacement (TAVR).

Bayer, the maker of rivaroxaban (trade name: Xarelto), sent a letter to healthcare professionals Oct. 3 explaining the study’s data safety monitoring board recommended terminating the trial in August after a preliminary analysis. That data indicated rivaroxaban was associated with higher rates of death or a first thromboembolic event (11.4 percent versus 8.8 percent), all-cause death (6.8 percent versus 3.3 percent) and primary bleeding events (4.2 percent versus 2.3 percent) compared to antiplatelet treatment.

“These results are preliminary and based on incomplete data collection,” stated the letter, which was signed by Tristan P. Cooper, medical director for Bayer. “The final study data will be assessed by regulatory authorities as soon as they are available, including an assessment of any implications for approved indications.”

At the time of termination, the study had randomized 826 patients to the rivaroxaban group and 818 to the antiplatelet group. Individuals in the prior arm were treated daily doses of rivaroxaban (10 mg) and aspirin (75-100 mg) for 90 days, followed by maintenance with 10 mg per day of rivaroxaban. The antiplatelet group was given 75-100 mg of aspirin plus 75 mg of clopidogrel for 90 days, followed by aspirin monotherapy.

“Rivaroxaban is not approved for thromboprophylaxis in patients with prosthetic heart valves, including patients who have undergone TAVR, and should not be used in such patients,” the letter reads. “Rivaroxaban treatment should be stopped in patients who undergo TAVR and switched to standard of care.”

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