Valvular & structural heart disease
Routine versus selective protamine administration to reduce bleeding after transcatheter aortic valve implantation (TAVI): Rationale and design of the POPular ACE TAVI trial
Study context
- Population
- Patients undergoing TAVIplanned
- Participants
- 1,000 patients
- Planned comparison
- Routine vs selective protamine administration after TAVI
- Primary endpoint
- All-cause mortality and clinically relevant bleeding (VARC-3 type 1-4)
- Follow-up
- 30 days after TAVI
Methodological detailsdesign and rationale, investigator-initiated, multicenter, double-blind, placebo-controlled, 1:1 randomisation, stratified by site and antithrombotic therapy, Ranked secondary outcomes: clinically relevant bleeding; major, life-threatening or fatal bleeding (type 2-4); major vascular complications; CV mortality; all-cause mortality, Safety outcomes: anaphylaxis; thromboembolic events (MI, ischemic stroke, TIA or noncerebral distal embolization), Recruitment began November 2023; trial ends after 30-day follow-up of last patient
- Design and rationale
- Investigator-initiated
- Multicenter
- Double-blind
- Placebo-controlled
- 1:1 randomisation, stratified by site and antithrombotic therapy
- Ranked secondary outcomes: clinically relevant bleeding; major, life-threatening or fatal bleeding (type 2-4); major vascular complications; CV mortality; all-cause mortality
- Safety outcomes: anaphylaxis; thromboembolic events (MI, ischemic stroke, TIA or noncerebral distal embolization)
- Recruitment began November 2023; trial ends after 30-day follow-up of last patient
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Routine versus selective protamine administration to reduce bleeding after TAVI: Rationale and design of the POPular ACE TAVI trial. Am Heart J. Published 31 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →