The widely accepted strategy of antiplatelet therapy to stem the risk of thrombosis in the months after transcatheter aortic valve replacement (TAVR) is again being challenged – this time as researchers set out to investigate the effects of a NOAC-based regimen post-TAVR in patients without atrial fibrillation.
The study, called GALILEO, will be the first randomised control trial to compare the two antithrombotic regimens in non-AF TAVR patients.
Researchers say the findings could change the way cardiologists approach and manage patients following TAVR.
In the trial protocol published earlier this week, the German researchers said as many as one in 20-25 patients have a stroke or other cardiovascular adverse events within the first year of undergoing TAVR.
They say the ideal antithrombotic regimen balancing ischaemic and bleeding risk requires further investigation.
“Currently, dual-antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel for 3 to 6 months (without an indication for chronic OAC) is an empirical, widely accepted strategy that has been incorporated into clinical practice and relevant recommendations. However, these recommendations lack consistency regarding appropriate dosage and duration of therapy,” the researchers claim.
They maintain that that the value of oral anticoagulation after TAVR, even among those without AF, should be investigated given recent reports of a higher incidence of cerebrovascular events in patients with possible subclinical valve thrombosis manifesting as reduced leaflet motion.
According to the researchers, reduced leaflet motion was less frequently observed among patients receiving oral anticoagulation compared with those receiving no anticoagulation.
What’s more, initiation of oral anticoagulation once reduced leaflet motion was identified resolved the condition, they noted.
GALILEO will include 1520 patients without AF, and compare rivaroxaban (Xarelto, Bayer/Janssen) treatment with standard antiplatelet treatment in reducing thromboembolic events after TAVR.
A strategy of rivaroxaban 10 mg once daily in combination with ASA for the first 90 days, followed by rivaroxaban 10 mg once daily alone, might provide the best tradeoff between efficacy and bleeding risk in this population without an established indication for anticoagulation after TAVR, the research team proposed.