After TAVR without another indication, a three-month DOAC added harm and only a temporary imaging benefit

Design

Randomised controlled trial, powered for superiority (NOTION-4)

Population

347 patients after successful TAVR without an indication for oral anticoagulation

Primary outcome

Hypoattenuated leaflet thickening on CT at 12 months

Effect

28.3% vs 32.2% (difference −3.9%, 95% CI −14.4 to 6.6); death/stroke/major bleeding 8.2% vs 2.3%

NOTION-4 randomised 347 TAVR patients with no indication for oral anticoagulation to lifelong single antiplatelet therapy or three months of a direct oral anticoagulant followed by lifelong single antiplatelet therapy. The primary endpoint was CT-detected hypoattenuated leaflet thickening (HALT) at 12 months.

At three months, while patients were still on the DOAC, HALT was 12.1% versus 31.8%. By one year — nine months after stopping — it was 28.3% versus 32.2% (difference −3.9%, 95% CI −14.4 to 6.6), so the primary endpoint was not met. Meanwhile, death, stroke or major/life-threatening bleeding at a year was 8.2% on the DOAC strategy versus 2.3% on single antiplatelet therapy (difference 5.9%, 95% CI 1.2–10.6).

The clinical composite was not the primary endpoint and the numbers are small, but the direction is consistent with GALILEO and ATLANTIS: anticoagulating TAVR patients who have no other reason for it does not help and may hurt. The imaging effect reverses when the drug stops.

• After TAVR with no separate indication for anticoagulation, use single antiplatelet therapy alone.
• Do not add a short DOAC course to prevent leaflet thickening; the effect vanished after stopping.
• Death, stroke or major bleeding at a year was about 6 percentage points higher with the DOAC strategy.
• Patients who do have an indication, such as AF, still need anticoagulation — this trial excluded them.

Why it matters

It closes the 'short course might be the sweet spot' argument that kept some teams anticoagulating after TAVR to protect the leaflets.

Don't overread it

The clinical harm was a secondary composite in a 347-patient trial; the reliable finding is that the primary imaging benefit did not last.

The statistics, in plain English

The 12-month HALT difference has a confidence interval running from a 14-point benefit to a 7-point harm, so no lasting effect was shown. The clinical composite's interval (1.2 to 10.6 points worse) stays above zero, but secondary endpoints in small trials can overstate effects.

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