POPular ACE TAVI
Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
Patient / Population Intervention / Exposure Comparison Outcome
In 1,000 patients undergoing transfemoral TAVI, routine protamine after the procedure was compared with selective protamine on death or bleeding at 30 days.
N
1,000
Design
investigator-initiated, multicentre (6 sites, Netherlands and Belgium), double-blind, placebo-controlled RCT; 1:1 routine vs selective protamine, stratified by site and antithrombotic therapy; 30-day follow-up
Endpoint
composite of all-cause mortality or clinically relevant bleeding (VARC-3 type 1–4) within 30 days after TAVI