GALILEO-4D: Rivaroxaban-based Strategy Prevents Some Leaflet Thickening and Leaflet Motion

Rivaroxaban-based antithrombotic strategy was more effective at preventing some leaflet thickening and leaf motion than an antiplatelet strategy, new study results from the American Heart Association 2019 Scientific Sessions in Philadelphia suggest.

“Subclinical leaflet thrombosis has been reported in bioprosthetic aortic valves,” the authors wrote in background portion of their study their abstract. “Cardiac four-dimensional computed tomography (4DCT) has been used to detect this phenomenon and describes it as hypo-attenuating leaflet thickening (HALT) with or without reduced leaflet motion (RLM).”

Researchers for this multicenter, open-label, randomized, active-controlled substudy of the GALILEO trial enrolled 231 patients from 12 centers across five countries, who were randomized (1:1) to receive  10 mg of rivaroxaban plus 75-100 mg of acetylsalicylic acid (ASA) over the duration of 90 days, followed by rivaroxaban monotherapy versus ASA 75-100 mg plus clopidogrel 75 mg for 90 days, followed by ASA monotherapy. The researchers postulated that a rivaroxaban-based therapy would be superior to an antiplatelet-based therapy in reducing hypo-attenuating leaflet thickening (HALT) and reduced leaflet motion (RLM). The primary endpoint was the rate of patients with subclinical leaflet thrombosis as assessed by cardiac four-dimensional computed tomography (4DCT). Secondary outcomes were defined as the rate of prosthetic leaflets with HALT/RLM.

The analysis results indicated that a 10 mg daily dose rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing HALT and RLM in TAVR patients without an indication for chronic oral anticoagulation.

The researchers noted the importance of placing the overall clinical results of the main GALILEO trial, versus an antiplatelet-based treatment strategy as a routine for TAVR patients without an indication for chronic oral anticoagulation.