Home Publications Research Grants Inventions & Patents Awards Additional Research Activities Faculties & Institutions Research Areas

Reduced leaflet motion after transcatheter aortic-valve replacement

de Backer O, Dangas GD, Jilaihawi H, Leipsic JA, Terkelsen CJ, Makkar R, Kini AS, Veien KT, Abdel-Wahab M, Kim WK, Balan P, van Mieghem N, Mathiassen ON, Jeger RV, Arnold M, Mehran R, Guimarães AH, Nørgaard BL, Kofoed KF, Blanke P, Windecker S, Søndergaard L (2020)

---

Publication Type: Journal article

Publication year: 2020

Journal

Book Volume: 382

Pages Range: 130-139

Journal Issue: 2

DOI: 10.1056/NEJMoa1911426

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.

Authors with CRIS profile

Additional Organisation(s)

Involved external institutions

How to cite

APA:

de Backer, O., Dangas, G.D., Jilaihawi, H., Leipsic, J.A., Terkelsen, C.J., Makkar, R.,... Søndergaard, L. (2020). Reduced leaflet motion after transcatheter aortic-valve replacement. New England Journal of Medicine, 382(2), 130-139. https://doi.org/10.1056/NEJMoa1911426

MLA:

de Backer, Ole, et al. "Reduced leaflet motion after transcatheter aortic-valve replacement." New England Journal of Medicine 382.2 (2020): 130-139.

BibTeX: Download