1. Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement
- Author
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Ole, De Backer, George D, Dangas, Hasan, Jilaihawi, Jonathon A, Leipsic, Christian J, Terkelsen, Raj, Makkar, Annapoorna S, Kini, Karsten T, Veien, Mohamed, Abdel-Wahab, Won-Keun, Kim, Prakash, Balan, Nicolas, Van Mieghem, Ole N, Mathiassen, Raban V, Jeger, Martin, Arnold, Roxana, Mehran, Ana H C, Guimarães, Bjarne L, Nørgaard, Klaus F, Kofoed, Philipp, Blanke, Stephan, Windecker, Lars, Søndergaard, and Cardiology
- Subjects
Male ,medicine.medical_treatment ,Computed tomography ,030204 cardiovascular system & hematology ,0302 clinical medicine ,Rivaroxaban ,Valve replacement ,Atrial Fibrillation ,Medicine ,030212 general & internal medicine ,610 Medicine & health ,Aged, 80 and over ,Prosthetic valve ,Leaflet (botany) ,medicine.diagnostic_test ,General Medicine ,Clopidogrel ,Intention to Treat Analysis ,CARDIOLOGY ESC ,Cardiovascular Diseases ,Aortic Valve ,Heart Valve Prosthesis ,cardiovascular system ,Cardiology ,Drug Therapy, Combination ,Female ,lipids (amino acids, peptides, and proteins) ,Thickening ,medicine.medical_specialty ,Transcatheter aortic ,SOCIETY ,Hemorrhage ,TAVR ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,Thromboembolism ,Internal medicine ,MANAGEMENT ,Humans ,cardiovascular diseases ,Four-Dimensional Computed Tomography ,Aged ,EUROPEAN ASSOCIATION ,Aspirin ,business.industry ,technology, industry, and agriculture ,THROMBOSIS ,Multicenter study ,IMPLANTATION ,business ,Platelet Aggregation Inhibitors ,Factor Xa Inhibitors - 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. (Funded by Bayer; GALILEO-4D ClinicalTrials.gov number, NCT02833948.).
- Published
- 2020
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