Short-Term Anticoagulant Therapy and Subclinical Leaflet Thickening in Transcatheter Aortic Valves: The NOTION-4 Trial.

Authors

Troels Højsgaard Jørgensen, Andreas Fuchs Larsen, Jesper Møller Jensen, Rebekka Vibjerg Jensen, Yannick Willemen, Aekapat Phoksiri, Arif Khokhar, Jani Thuraiaiyah, Kamilla Bech Pedersen, Gintautas Bieliauskas, Christian Juhl Terkelsen, Lars Søndergaard, Klaus Fuglsang Kofoed, Bjarne Linde Nørgaard, Ole De Backer, NOTION-4 Investigators

Published in

Journal of the American College of Cardiology. Aug 30, 2026. Epub Aug 30, 2026.

Abstract

Following transcatheter aortic valve replacement (TAVR), subclinical leaflet thrombosis-visualized on cardiac computed tomography (CT) as hypoattenuated leaflet thickening (HALT)-is common and might be associated with thromboembolic events.
The NOTION-4 trial investigates different antithrombotic treatment strategies for the prevention of HALT.
NOTION-4 was a randomized controlled trial enrolling patients without an indication for oral anticoagulation shortly after successful TAVR. Patients were randomized to lifelong single antiplatelet therapy (SAPT) or 3 months of direct oral anticoagulant (DOAC) therapy followed by lifelong SAPT (DOAC-3m). The primary endpoint was HALT prevalence at 12 months. The trial was powered for superiority of the experimental strategy.
Of 352 patients randomized 1:1, 5 were screen failures or withdrew consent, leaving 176 in the SAPT group and 171 in the DOAC-3m group. At 3 months, HALT was observed in 31.8% of patients receiving SAPT compared with 12.1% of those receiving DOAC-3m. At 1 year, HALT occurred in 32.2% of SAPT patients and 28.3% of DOAC-3m patients with available CT scans (risk difference: -3.9%; 95% CI: -14.4% to 6.6%; P = 0.54). The combined risk of all-cause mortality, stroke, or major/life-threatening bleeding at 12 months was 2.3% in the SAPT group vs 8.2% in the DOAC-3m group (risk difference: 5.9%; 95% CI: 1.2% to 10.6%).
Among TAVR patients without an indication for oral anticoagulation, 3 months of DOAC therapy significantly reduced the prevalence of HALT at 3 months compared with SAPT; however, this effect was attenuated by 9 months after discontinuation of DOAC therapy. (The Nordic Aortic Valve Intervention Trial 4 [NOTION-4]; NCT06449469).

PMID:
42669071
Bibliographic data and abstract were imported from PubMed on 30 Aug 2026.

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