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Short-Term Anticoagulant Therapy and Subclinical Leaflet Thickening in Transcatheter Aortic Valves
Key result
Three months of DOAC therapy fails to reduce 12-month HALT prevalence vs SAPT after TAVR.
- risk difference -3.9%
- 95% CI -14.4% to 6.6%
- P=0.54
- n=352
Why the trial?
Hypoattenuated leaflet thickening appears on CT in a substantial minority of TAVI recipients, with unclear clinical significance and no established prevention strategy. NOTION-4 asked whether a three-month DOAC course after TAVI durably prevents subclinical leaflet thrombosis.
Does 3 months of DOAC therapy followed by SAPT reduce HALT prevalence at 12 months in TAVR patients without an indication for oral anticoagulation compared to lifelong SAPT?
Population
352 randomized (347 analyzed) post-TAVR patients with no OAC indication
Comparison
3 months of DOAC then lifelong SAPT vs lifelong SAPT alone
Design
Randomized (1:1) controlled trial powered for superiority (NOTION-4)
Follow-up
12 months
Authors
Discussion
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Implication
Short-term DOAC after TAVI increases clinical events; reinforces guidelines against routine anticoagulation in patients without other indications.
Key Points
- To evaluate whether a 3-month course of direct oral anticoagulants followed by single antiplatelet therapy reduces hypoattenuated leaflet thickening compared with antiplatelet therapy alone after transcatheter aortic valve replacement.
- Randomized controlled superiority trial (NOTION-4; NCT06449469) enrolling post-TAVR patients without standard indications for oral anticoagulation.
- Assigned 352 patients (1:1) to lifelong single antiplatelet therapy (SAPT; n=176) or 3 months of direct oral anticoagulation followed by lifelong SAPT (DOAC-3m; n=171).
- Evaluated hypoattenuated leaflet thickening (HALT) on cardiac CT at 3 and 12 months, with 12-month HALT prevalence as the primary endpoint.
- At 3 months, HALT occurred in 31.8% of patients receiving SAPT compared with 12.1% receiving DOAC-3m.
- At 12 months, HALT prevalence was 32.2% with SAPT versus 28.3% with DOAC-3m (risk difference: -3.9%; 95% CI: -14.4% to 6.6%; P = 0.54).
- Combined all-cause mortality, stroke, or major/life-threatening bleeding at 12 months occurred in 2.3% of the SAPT group versus 8.2% of the DOAC-3m group (risk difference: 5.9%; 95% CI: 1.2% to 10.6%).
Evidence details
What drove the result?
| Outcome | DOAC 3m | SAPT |
|---|---|---|
| HALT prevalence at 12 months | 28.3% | 32.2% |
| Primary · RD −3.9% (95% CI −14.4% to 6.6%); p=0.54 — superiority not met; among patients with available CT | ||
| HALT prevalence at 3 months | 12.1% | 31.8% |
| Secondary · on-treatment reduction was not sustained after DOAC discontinuation | ||
Limitations & tradeoffs
Safety
All-cause death, stroke, or major/life-threatening bleeding at 12 months was 8.2% vs 2.3% (RD 5.9%; 95% CI 1.2% to 10.6%) — higher with DOAC-3m.
Design limitations
HALT is a surrogate imaging endpoint that the abstract notes only might be associated with thromboembolic events, and the 12-month primary analysis included only patients with available CT scans.
Statistical certainty
The excess of clinical events with DOAC-3m rests on few events in a modest sample; per-arm counts are not reported.
Structured PICO
Does 3 months of DOAC therapy followed by SAPT reduce HALT prevalence at 12 months in TAVR patients without an indication for oral anticoagulation compared to lifelong SAPT?
P
Population
347 patients without an indication for oral anticoagulation shortly after successful TAVR, followed for 12 months.
I
Intervention
3 months of direct oral anticoagulant (DOAC) therapy followed by lifelong single antiplatelet therapy (SAPT).
C
Comparator
Lifelong single antiplatelet therapy (SAPT).
O
Outcome
Hypoattenuated leaflet thickening (HALT) prevalence at 12 months.surrogate
Main Result
Effect estimate: risk difference -3.9% (95% CI -14.4% to 6.6%)
Absolute Event Rate: 28.3% vs 32.2%
p-value: p=0.54
Short-term DOAC therapy after TAVR temporarily reduces subclinical leaflet thrombosis but does not provide sustained benefit at 1 year and increases the risk of adverse clinical events.
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Cite This Study
Jørgensen et al. (2026) conducted an RCT in Transcatheter aortic valve replacement (TAVR) (n=352). 3 months of direct oral anticoagulant (DOAC) therapy followed by lifelong SAPT vs. Lifelong single antiplatelet therapy (SAPT) was evaluated on HALT prevalence at 12 months (risk difference -3.9%, 95% CI -14.4% to 6.6%, p=0.54). Among TAVR patients without an indication for oral anticoagulation, 3 months of DOAC therapy did not significantly reduce HALT prevalence at 12 months compared with SAPT (28.3% vs 32.2%; P=0.54).