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Dear Doctor Letter (Rote-Hand-Brief) on Rivaroxaban (Xarelto®): increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacement in a prematurely stopped clinical trial
2018.10.02
Active substance: rivaroxaban
A phase III clinical study, 17938 (GALILEO), conducted in patients after transcatheter aortic valve replacement (TAVR) has been terminated ahead of schedule based on preliminary results showing an increase in all-cause mortality, thromboembolic and bleeding events in rivaroxaban-treated patients. 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.
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