Valvular & structural heart disease

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

J Am Coll CardiolPublished Randomised controlled trial

Primary result · HALTResult — go to the resultRisk difference −3.9% 95% CI −14.4% to 6.6%

Authors' conclusion

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.

Study context

Population
Patients without an indication for OAC shortly after successful transcatheter aortic valve replacement (TAVR)5 screen failures or withdrew consent
Participants
352 patients
Comparison
3 months of direct oral anticoagulant (DOAC) then lifelong single antiplatelet therapy (SAPT) vs lifelong SAPT after TAVR
  • SAPTn = 176reference
  • DOAC-3mn = 171
Primary endpoint
Hypoattenuated leaflet thickening (HALT) prevalence
Follow-up
12 months
Methodological detailssuperiority
  • Superiority

Primary result

HALT · 1 year

Risk difference

−3.9%

95% CI −14.4% to 6.6%

P = 0.54

By group

DOAC-3m vs SAPT
risk difference −3.9% (95% CI −14.4% to 6.6%); P = 0.54

As reported in the abstract

Further findings

HALT · 3 months

OutcomeSAPTDOAC-3mRisk difference (95% CI)
All-cause mortality, stroke, or major/life-threatening bleeding · 12 months2.3%8.2%5.9% (1.2%–10.6%)

Original publication

Short-Term Anticoagulant Therapy and Subclinical Leaflet Thickening in Transcatheter Aortic Valves: The NOTION-4 Trial. J Am Coll Cardiol. Published 30 August 2026. doi:10.1016/j.jacc.2026.08.023

Summarised from the published abstract; every number is checked against it

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