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Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement.
- Source :
-
New England Journal of Medicine . 1/9/2020, Vol. 382 Issue 2, p130-139. 10p. - Publication Year :
- 2020
-
Abstract
- <bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusions: </bold>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.). [ABSTRACT FROM AUTHOR]
- Subjects :
- *ANTICOAGULANTS
*AORTIC valve
*ASPIRIN
*ATRIAL fibrillation
*COMBINATION drug therapy
*CLINICAL trials
*COMPARATIVE studies
*COMPUTED tomography
*PROSTHETIC heart valves
*HEMORRHAGE
*RESEARCH methodology
*MEDICAL cooperation
*RESEARCH
*THROMBOEMBOLISM
*EVALUATION research
*PLATELET aggregation inhibitors
*PHARMACODYNAMICS
CARDIOVASCULAR disease related mortality
Subjects
Details
- Language :
- English
- ISSN :
- 00284793
- Volume :
- 382
- Issue :
- 2
- Database :
- Academic Search Index
- Journal :
- New England Journal of Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 141144053
- Full Text :
- https://doi.org/10.1056/NEJMoa1911426