GALILEO Trial Finds Higher Risk of Death, Bleeding With Rivaroxaban After TAVR
In patients who had undergone TAVR without an established indication for oral anticoagulation, a treatment strategy of anticoagulation with 10 mg of rivaroxaban daily may be "associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding" vs. an antiplatelet-based strategy, according to results of the GALILEO trial presented Nov. 16 during AHA 2019 in Philadelphia, PA, and simultaneously published in the New England Journal of Medicine.
G.D. Dangas, MD, PhD, FACC, et al., randomly assigned 1,644 patients without an established indication for oral anticoagulation who had undergone TAVR to a rivaroxaban group receiving 10 mg of rivaroxaban daily with 75 to 100 mg of aspirin daily for the first three months; vs. an antiplatelet group receiving 75 to 100 mg of aspirin daily with clopidogrel for the first three months.
Results showed after a median of 17 months, the primary efficacy outcome of death or first thromboembolic event had occurred in 105 patients vs. 78 patients in the rivaroxaban groups and antiplatelet group, respectively. The primary safety outcome of major, disabling or life-threatening bleeding had occurred in 46 and 31 patients, respectively.
The authors conclude that their study "underscores the challenge of antithrombotic therapy in the TAVR population, which includes patients who are generally elderly, potentially frail, or affected by multiple coexisting conditions associated with an increased risk of both bleeding and thromboembolic events."
Meanwhile, in the GALILEO-4D trial, also published in the New England Journal of Medicine, investigators looked at a substudy of patients in the main GALILEO trial and found that rivaroxaban was associated "with a lower incidence of subclinical valve-leaflet thickening and reduced leaflet motion than antiplatelet therapy."
Ole De Backer, MD, PhD, MBA, et al., looked at 231 patients who underwent evaluation by 4D CT at a mean of 90 days after randomization. Results showed that the primary endpoint of the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients in the rivaroxaban group vs. 11 of 101 in the antiplatelet group. Further, leaflet thickening was observed in 12 of 97 patients and 33 of 102 patients in the rivaroxaban and antiplatelet groups, respectively.
However, the authors conclude that they cannot "recommend routine imaging for the detection of reduced leaflet motion or the routine use of anticoagulation after TAVR with the aim of preventing leaflet-motion abnormalities, given the unfavorable clinical outcomes with rivaroxaban in the main GALILEO trial."
Keywords: AHA19, AHA Annual Scientific Sessions, Aortic Valve, Heart Valve Prosthesis, Aortic Valve Stenosis, Geriatrics, Angiography, Percutaneous Coronary Intervention, Heart Valve Diseases, Cardiac Surgical Procedures
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