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Routine versus selective protamine administration to reduce bleeding after TAVI: Rationale and design of the POPular

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This trial investigates if routine protamine after transcatheter aortic valve implantation (TAVI) reduces mortality or bleeding. Results will clarify protamine

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Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Clinical Trials

Background:

  • Unfractionated heparin is standard during transcatheter aortic valve implantation (TAVI) to prevent clots.
  • Protamine sulfate can reverse heparin but carries risks like allergic reactions.
  • Limited data exists on the routine use of protamine post-TAVI.

Purpose of the Study:

  • To assess if routine protamine administration after TAVI reduces all-cause mortality or clinically relevant bleeding.
  • To compare routine versus selective protamine use in TAVI patients.

Main Methods:

  • The POPular ACE TAVI trial is a multicenter, double-blind, placebo-controlled randomized clinical trial.
  • 1000 patients will be randomized to routine or selective protamine administration.
  • Primary outcome: composite of all-cause mortality and clinically relevant bleeding within 30 days post-TAVI, per VARC-3 criteria.

Main Results:

  • The study is ongoing, with recruitment started in November 2023.
  • Primary and secondary outcomes are defined by VARC-3 criteria.
  • Safety outcomes include anaphylaxis and thromboembolic events.

Conclusions:

  • The POPular ACE TAVI trial (NCT05774691) will provide crucial data on protamine use after TAVI.
  • Findings will guide clinical practice regarding routine versus selective protamine administration.