GALILEO: Rivaroxaban-Based Antithrombotic Strategy or Antiplatelet-Based Strategy After TAVR?

New research from the American Heart Association 2019 Scientific Sessions in Philadelphia suggest that different future trials are required to compare antiplatelets among transcatheter aortic valve replacement (TAVR) patients not requiring anticoagulation.

The Global Comparison of a Rivaroxaban-Based Antithrombotic Strategy versus an Antiplatelet-Based Strategy After Transcatheter Aortic Valve Replacement to Optimize Clinical Outcomes (GALILEO) trial was a  global, multicenter, open-label, randomized, event-driven, active-controlled phase III trial, researchers compared a rivaroxaban-based strategy versus an antiplatelet-based strategy after successful TAVR in 1,644 randomized patients who did have an ongoing indication for oral anticoagulation, such as atrial fibrillation, at the time of randomization.

The primary efficacy endpoint was the composite of all-cause death or thromboembolic events (including any stroke, myocardial infarction, symptomatic valve thrombosis, non-central nervous system systemic embolism, deep venous thrombosis or pulmonary embolism). The primary safety endpoint was the composite of major, disabling or life-threatening bleeding events according to the VARC-2 criteria.

The study results suggested that when comparing the two groups as formed in the very beginning, the rivaroxaban arm had higher rates of death or thromboembolic complications, and more bleeding complications. The trial was stopped early due to an increase in all-case mortality, and thromboembolic and bleeding events, in the rivaroxaban cohort. The researchers noted these high number of deaths could not be directly attributed to the higher bleeding rate observed the rivaroxaban arm.

Among patients randomized to rivaroxaban who died, a minority developed a significant bleeding event, heart attack or stroke 30 days prior to death. Most of the examined causes of death in the rivaroxaban arm were either sudden, occurred for unknown reasons, or were due to non-CV events. This left mechanism underlying the higher mortality in the rivaroxaban arm observed in the trial unclear, according to the researchers.

A discussant presentation noted that the implications of the study would first require awaiting the results of the TAVR population and noted that rivaroxaban 2.5 mg BID may be a reasonable dosage to study in future research.