Bayer sent a “Dear Healthcare Professional” letter informing clinicians that the GALILEO trial of rivaroxaban for patients who underwent transcatheter aortic valve replacement was stopped due to poor outcomes in the rivaroxaban arm.
The trial “has been terminated early based on preliminary results showing an increase in all-cause mortality, thromboembolic and bleeding events in rivaroxaban-treated patients,” Tristan P. Cooper, MB, BCh, BAO, FFPM, medical director for Bayer, wrote in the letter. “Analyses are ongoing. 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. Rivaroxaban treatment should be stopped in patients who undergo TAVR and switched to standard of care.”
According to the letter, 1,644 patients who underwent TAVR were assigned rivaroxaban (Xarelto, Janssen/Bayer) 10 mg once daily and aspirin 75 mg to 100 mg once daily for 90 days followed by maintenance with rivaroxaban 10 mg once daily (n = 826) or clopidogrel 75 mg once daily and aspirin 75 mg to 100 mg once daily for 90 days followed by aspirin once daily (n = 818).
After a preliminary analysis, the data and safety monitoring board recommended stopping the trial, according to the letter, which noted that death or first thromboembolic event occurred in 11.4% of the rivaroxaban group vs. 8.8% of the clopidogrel group, all-cause mortality occurred in 6.8% of the rivaroxaban group vs. 3.3% of the clopidogrel group and major, life-threatening or disabling bleeding events occurred in 4.2% of the rivaroxaban group vs. 2.4% of the clopidogrel group.
“These results are preliminary and based on incomplete data collection,” Cooper wrote. “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.”
Disclosure: Cooper is an employee of Bayer.