@article{3104861, title = "Reduced leaflet motion after transcatheter aortic-valve replacement", author = "de Backer, O. and Dangas, G.D. and Jilaihawi, H. and Leipsic, J.A. and Terkelsen, C.J. and Makkar, R. and Kini, A.S. and Veien, K.T. and Abdel-Wahab, M. and Kim, W.-K. and Balan, P. and van Mieghem, N. and Mathiassen, O.N. and Jeger, R.V. and Arnold, M. and Mehran, R. and Guimarães, A.H.C. and Nørgaard, B.L. and Kofoed, K.F. and Blanke, P. and Windecker, S. and Søndergaard, L. and GALILEO-4D Investigators", journal = "The New England journal of medicine", year = "2020", volume = "382", number = "2", pages = "130-139", publisher = "Massachussetts Medical Society", doi = "10.1056/NEJMoa1911426", keywords = "acetylsalicylic acid; rivaroxaban; acetylsalicylic acid; antithrombocytic agent; blood clotting factor 10a inhibitor; clopidogrel; rivaroxaban, aged; anticoagulation; Article; bleeding; cardiovascular risk; clinical trial; computer assisted tomography; echocardiography; female; human; major clinical study; male; mortality risk; open study; priority journal; thromboembolism; transcatheter aortic valve implantation; aortic valve; atrial fibrillation; cardiovascular disease; combination drug therapy; comparative study; controlled study; drug effect; four dimensional computed tomography; heart valve prosthesis; intention to treat analysis; mortality; multicenter study; pathology; pathophysiology; randomized controlled trial; thromboembolism; very elderly, Aged; Aged, 80 and over; Aortic Valve; Aspirin; Atrial Fibrillation; Cardiovascular Diseases; Clopidogrel; Drug Therapy, Combination; Factor Xa Inhibitors; Female; Four-Dimensional Computed Tomography; Heart Valve Prosthesis; Hemorrhage; Humans; Intention to Treat Analysis; Male; Platelet Aggregation Inhibitors; Rivaroxaban; Thromboembolism; Transcatheter Aortic Valve Replacement", abstract = "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. Copyright © 2019 Massachusetts Medical Society." }