Short-Term Anticoagulant Therapy and Subclinical Leaflet Thickening in Transcatheter Aortic Valves: The NOTION-4 Trial
In brief
Three-month DOAC course cuts early leaflet thickening from one-third to one-tenth after TAVR
In the NOTION-4 trial, patients receiving three months of a direct oral anticoagulant after transcatheter aortic valve replacement had HALT in 12% versus 32% with single antiplatelet therapy at three months, a near-20-percentage-point drop. By one year the difference disappeared, and the combined risk of death, stroke or major bleeding was higher with the short-term anticoagulant.
- Journal
- Journal of the American College of Cardiology (Q1)
- Published
- 30 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Troels Højsgaard Jørgensen, Andreas Fuchs Larsen, Jesper Møller Jensen, Rebekka Vibjerg Jensen, Yannick Willemen, Aekapat Phoksiri, et al.
- PMID
- 42669071
- DOI
- 10.1016/j.jacc.2026.08.023
Why clinicians should know about it
- Picked for Radiology, Radiation Oncology, Nuclear Medicine, Medical Physics and Imaging (top studies of the week, 18 October 2026): DOAC reduces HALT at 3 months after TAVR
Abstract
BACKGROUND: 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. OBJECTIVES: The NOTION-4 trial investigates different antithrombotic treatment strategies for the prevention of HALT. METHODS: 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. RESULTS: 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%). CONCLUSIONS: 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).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.