NOTION-4
The Nordic Aortic Valve Intervention Trial 4 — Prospective Study on the Impact of Different Anti-thrombotic Therapies on Subclinical Leaflet Thickening and Its Temporal Dynamics in Transcatheter Bioprosthetic Aortic Valves
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 352 patients after TAVI without an indication for anticoagulation, 3 months of a DOAC, then antiplatelet therapy was compared with antiplatelet therapy alone on leaflet thrombosis on CT at 1 year.
N
352
Schéma
investigator-initiated, randomised, open-label, superiority trial at two Danish centres (Rigshospitalet Copenhagen, Aarhus University Hospital); early 3-month DOAC then single antiplatelet vs lifelong single antiplatelet therapy; 4D-CT and clinical assessment at 3 months, 1 year and 5 years
Critère
number of patients with at least one bioprosthetic aortic valve leaflet with HALT on 4-dimensional cardiac CT at 1 year after TAVI