Year: 2019
Type: article
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.).
Source: New England Journal of Medicine
Authors: 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
Institutions: University of Copenhagen, University of British Columbia, National and Kapodistrian University of Athens, Copenhagen University Hospital, Rigshospitalet, NYU Langone Health, Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, Mount Sinai Hospital, St. Paul's Hospital, Aarhus University Hospital, Cedars-Sinai Medical Center, Cedars-Sinai Smidt Heart Institute, Odense University Hospital, Universitätsklinikum Erlangen, Segeberger Kliniken, Leipzig University, Kerckhoff Klinik, The University of Texas Health Science Center at Houston, Erasmus MC, University of Basel, University Hospital of Basel, Cardialysis (Netherlands), European Cardiovascular Research Institute, University of Bern, University Hospital of Bern
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Bayer, Janssen Pharmaceuticals
OpenAlex ID: W2982829887