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

EuroInterventionPublished Rationale and design of a randomised controlled 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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