Bayer: GALILEO Trial Halted Early Due To Increased Mortality, Events

An increase in mortality and bleeding events were cited as reasons for a halt on the GALILEO trial, according to a letter from the trial sponsor, Bayer Pharmaceuticals.

The GALILEO trial, a phase III clinical study of a rivaroxaban-centered anticoagulation strategy in patients who had undergone transcatheter aortic valve replacement (TAVR), was halted in August 2018 by the independent Data Safety and Monitoring Board (DSMB) due to preliminary results showing an increase in all-cause mortality, thromboembolic events, and bleeding events.

“These results are preliminary and based on incomplete data collection,” Tristan D. Cooper, MD, Medical Director at Bayer, reported in a letter sent to health care professionals announcing the halt of the trial. “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.”

The manufacturer also noted that rivaroxaban was not approved for thrombophylaxis in patients with prosthetic heart valves (which includes patients who underwent TAVR), and that rivaroxaban “should not be used in such patients.” Bayer also specified that these results do not affect the other approved indications for rivaroxaban, which continues to be used for a number of other conditions such as the prevention of stroke in patients with atrial fibrillation.

According to ClincalTrials.gov, GALILEO had enrolled and randomized 1,644 patients (n=826, rivaroxaban group; n=818 antiplatelet group) at the time of DSMB intervention. The rates of death or first thromboembolic event were 11.4% versus 8.8%, respectively. The rates of all-cause death were 6.8% in the rivaroxaban group compared to 3.3% in the usual care group. Primary bleeding even rates were 4.2% for rivaroxaban versus 2.4% for usual care.

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