Valvular & structural heart diseaseRandomised controlled trial
Anticoagulation Monotherapy vs Antiplatelet Monotherapy After Transcatheter Aortic Valve Implant
- Randomised controlled trial
- prospective
- open-label
- blinded end point
- 3 Norwegian centres
- co-primary end points
Authors' conclusion
A strategy of NOAC monotherapy after TAVI reduced the incidence of HALT and was noninferior for bleeding, thromboembolic events, or death compared with acetylsalicylic acid monotherapy.
Study context
- Population
- Patients aged 65–80 years undergoing transcatheter aortic valve implant (TAVI) for severe aortic valve stenosis336 completed
- Participants
- 360 patients
- Comparison
- NOAC monotherapy vs acetylsalicylic acid (ASA) monotherapy after TAVI
- NOACn = 168
- ASAn = 168reference
- Primary endpoint
- Co-primary: efficacy = valve leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on blinded core-lab 4D cardiac computed tomographic (CT)); safety = composite of VARC-3 bleeding, thromboembolic events and all-cause death
- Follow-up
- 12 months
Primary result
HALT (primary efficacy)
Relative risk
0.55
95% CI 0.37–0.82
P = 0.004
Events by treatment group
NOAC vs ASA
RR 0.55 (95% CI 0.37–0.82); P = 0.004
As reported in the abstract
Safety
| Outcome | NOAC | ASA | risk difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Primary safety end point: VARC-3 bleeding, thromboembolic events, all-cause death · 12 months · noninferior · non-inferiority: noninferior | 7.5% | 10.6% | −3.3% (−9.5% to 2.8%) | P for non-inferiority < 0.001 | |
| −10−505Difference (linear scale) |
Original publication
Anticoagulation Monotherapy vs Antiplatelet Monotherapy After Transcatheter Aortic Valve Implant. JAMA. Published 30 August 2026. doi:10.1001/jama.2026.17036
Summarised from the published abstract; every number is checked against it