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Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement
Ole De Backer1, George D Dangas1, Hasan Jilaihawi1
1From the Heart Center, Rigshospitalet, Copenhagen University Hospital, University of Copenhagen, Copenhagen (O.D.B., K.F.K., L.S.); the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai Hospital (G.D.D., A.S.K., R. Mehran), and NYU Langone Health (H.J.) - both in New York; National and Kapodistrian University of Athens, Athens (G.D.D.); the Department of Medical Imaging, St. Paul's Hospital, University of British Columbia, Vancouver, Canada (J.A.L., P. Blanke); the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., O.N.M., B.L.N.), and the Department of Cardiology, Odense University Hospital, Odense (K.T.V.) - both in Denmark; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R. Makkar); the Department of Cardiology, Heart Center, Segeberger Kliniken, Bad Segeberg (M.A.-W.), Heart Center Leipzig, University of Leipzig, Leipzig (M.A.-W.), Kerckhoff Heart Center, Department of Cardiology and Cardiac Surgery, Bad Nauheim (W.-K.K.), and Kardiologie und Angiologie, Universitätsklinikum Erlangen, Erlangen (M.A.) - all in Germany; the Department of Internal Medicine, University of Texas Health Science Center, Houston (P. Balan); Thoraxcentrum, Erasmus Medisch Centrum (N.V.M.), European Cardiovascular Research Institute (A.H.C.G.), and Cardialysis, Academic Research Organization (A.H.C.G.) - all in Rotterdam, the Netherlands; and the Department of Cardiology, Basel University Hospital, University of Basel, Basel (R.V.J.), and the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern (S.W.) - both in Switzerland.
Background:
Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented by four-dimensional computed tomography (CT). Whether anticoagulation can reduce these phenomena after transcatheter aortic-valve replacement (TAVR) is not known.
Methods:
In a substudy of a large randomized trial, we randomly assigned patients who had undergone successful TAVR and who did not have an indication for long-term anticoagulation to a rivaroxaban-based antithrombotic strategy (rivaroxaban [10 mg] plus aspirin [75 to 100 mg] once daily) or an antiplatelet-based strategy (clopidogrel [75 mg] plus aspirin [75 to 100 mg] once daily). Patients underwent evaluation by four-dimensional CT at a mean (±SD) of 90±15 days after randomization. The primary end point was the percentage of patients with at least one prosthetic valve leaflet with grade 3 or higher motion reduction (i.e., involving >50% of the leaflet). Leaflet thickening was also assessed.
Results:
A total of 231 patients were enrolled. At least one prosthetic valve leaflet with grade 3 or higher motion reduction was found in 2 of 97 patients (2.1%) who had scans that could be evaluated in the rivaroxaban group, as compared with 11 of 101 (10.9%) in the antiplatelet group (difference, -8.8 percentage points; 95% confidence interval [CI], -16.5 to -1.9; P = 0.01). Thickening of at least one leaflet was observed in 12 of 97 patients (12.4%) in the rivaroxaban group and in 33 of 102 (32.4%) in the antiplatelet group (difference, -20.0 percentage points; 95% CI, -30.9 to -8.5). In the main trial, the risk of death or thromboembolic events and the risk of life-threatening, disabling, or major bleeding were higher with rivaroxaban (hazard ratios of 1.35 and 1.50, respectively).
Conclusions:
In a substudy of a trial involving patients without an indication for long-term anticoagulation who had undergone successful TAVR, a rivaroxaban-based antithrombotic strategy was more effective than an antiplatelet-based strategy in preventing subclinical leaflet-motion abnormalities. However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy. (Funded by Bayer; GALILEO-4D ClinicalTrials.gov number, NCT02833948.).
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