The Medicines and Healthcare products Regulatory Agency has issued a drug safety alert after recent results from the GALILEO trial, which showed an increase in all-cause mortality, thromboembolic and bleeding event with rivaroxaban (Xarelto) after transcatheter aortic valve replacement (TAVR).
The MHRA is advising that rivaroxaban treatment should be stopped in patients who undergo TAVR, and patients should be switched to an antiplatelet-based strategy instead.
Preliminary analysis of data from the phase 3 GALILEO trial shows risks for all-cause death and bleeding post-TAVR were approximately doubled in patients assigned to a rivaroxaban-based anticoagulation strategy (10 mg rivaroxaban once daily and aspirin 75-100 mg once daily for 90 days, followed by rivaroxaban 10 mg maintenance) compared with those assigned to receive an antiplatelet-based strategy (clopidogrel 75 mg and aspirin 75-100 mg once daily for 90 days, followed by aspirin alone).
In preliminary results, the rate of death or first thromboembolic event was 11% in the rivaroxaban group (117/826) compared to 9% in the antiplatelet group (87/818). All-cause mortality was 7% and 3%, respectively, while the rate of primary bleeding events was 4% and 2%, respectively.
The trial was halted in August 2018 on recommendation of the independent Data Safety Monitoring Board following a preliminary analysis of available data.
