Valvular & structural heart disease
Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE transcatheter aortic valve implantation (TAVI) trial
Study context
- Population
- Patients undergoing TAVI who use oral anticoagulants (OAC)planned enrolment
- Participants
- 858 patients
- Planned comparison
- Periprocedural continuation vs interruption of OAC during TAVI
- Primary endpoint
- Composite of:
- CV mortality
- All stroke
- MI
- Major vascular complications
- Type 2-4 bleeding (VARC-3 criteria)
- Follow-up
- Within 30 days after TAVI
Methodological detailsmulticentre, open-label, blinded endpoint assessment, 1:1 randomisation, stratified for VKA or DOAC use, non-inferiority, then superiority, Recruitment started in November 2020; follow-up 90 days
- Multicentre
- Open-label
- Blinded endpoint assessment
- 1:1 randomisation
- Stratified for VKA or DOAC use
- Non-inferiority, then superiority
- Recruitment started in November 2020; follow-up 90 days
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial. EuroIntervention. Published 17 November 2023. doi:10. 4244/ eij-d-23-00206
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