Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Ole De Backer, Rigshospitalet
  • ,
  • George D Dangas, Mount Sinai Hospital
  • ,
  • Hasan Jilaihawi, NYU Langone Health
  • ,
  • Jonathon A Leipsic, University of British Columbia
  • ,
  • Christian J Terkelsen
  • ,
  • Raj Makkar, Cedars-Sinai Medical Center
  • ,
  • Annapoorna S Kini, Mount Sinai Hospital
  • ,
  • Karsten T Veien, Odense University Hospital
  • ,
  • Mohamed Abdel-Wahab, Herzzentrum Segeberger Kliniken
  • ,
  • Won-Keun Kim, Kerckhoff Heart Center
  • ,
  • Prakash Balan, University of Texas
  • ,
  • Nicolas Van Mieghem, Erasmus Medisch Centrum
  • ,
  • Ole N Mathiassen
  • ,
  • Raban V Jeger, University of Basel
  • ,
  • Martin Arnold, Universitätsklinikum, Erlangen
  • ,
  • Roxana Mehran, Mount Sinai Hospital
  • ,
  • Ana H C Guimarães, European Cardiovascular Research Institute
  • ,
  • Bjarne L Nørgaard
  • ,
  • Klaus F Kofoed, Rigshospitalet
  • ,
  • Philipp Blanke, University of British Columbia
  • ,
  • Stephan Windecker, University of Bern
  • ,
  • Lars Søndergaard, Rigshospitalet
  • ,
  • GALILEO-4D Investigators

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.).

OriginalsprogEngelsk
TidsskriftThe New England Journal of Medicine
Vol/bind382
Nummer2
Sider (fra-til)130-139
Antal sider10
ISSN0028-4793
DOI
StatusUdgivet - 2020

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