Valvular & structural heart disease
An investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI
Study context
- Population
- Patients after successful transcatheter aortic valve implantation (TAVI) without indication for OACplanned
- Participants
- 360 patients
- Comparison
- Anti-factor Xa NOAC monotherapy vs single antiplatelet therapy (acetylsalicylic acid) after TAVI
- Primary endpoint
- Co-primary: (1) Hypo-Attenuated Leaflet Thickening (HALT) on 4-dimensional cardiac CT; (2) safety composite of VARC-3 bleeding, thromboembolic events (MI and stroke) and all-cause death
- Follow-up
- 12 months
Methodological detailsmulticentre, prospective, open-label, blinded endpoint, all-comers, pragmatic, 1:1 randomisation
- Multicentre
- Prospective
- Open-label
- Blinded endpoint
- All-comers
- Pragmatic
- 1:1 randomisation
Primary result
As reported in the abstract
Baseline characteristics of first 100 patients
- Mean age (years)
- 74 ± 3.6
- Female
- 33%
- Mean BMI (kg/m²)
- 27.9 ± 4.4
- Smokers
- 15%
- Balloon-expanded valve
- 82%
- Self-expandable valve
- 18%
Original publication
An investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI. Am Heart J. Published 25 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →