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Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single

Ran Liu1, Yang Li1, Lihua Zhang2

  • 1Interventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China.

Journal of the American Heart Association
|March 21, 2025
PubMed

Insights

The CREATE trial investigates stopping antiplatelet therapy one year after transcatheter aortic valve replacement. This study aims to reduce bleeding events without increasing ischemic risks in select patients.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Clinical Trials

Background:

  • Current guidelines recommend lifelong single antiplatelet therapy post-transcatheter aortic valve replacement (TAVR) without contraindications.
  • Evidence from randomized controlled trials supporting this practice is lacking.
  • The optimal duration of antiplatelet therapy after TAVR remains under-investigated.

Purpose of the Study:

  • To evaluate the efficacy and safety of discontinuing antiplatelet therapy at 1 year post-TAVR.
  • To determine if stopping antiplatelet therapy reduces bleeding events without increasing ischemic complications.

Main Methods:

  • The CREATE study is a prospective, multicenter, randomized controlled trial.
  • Patients are randomized 1:1 to either continue single antiplatelet therapy or stop it at 1 year post-TAVR.
  • Primary efficacy endpoint: bleeding events (VARC-3 criteria); Primary safety endpoint: composite of cardiac death, myocardial infarction, and ischemic stroke.

Main Results:

  • The CREATE trial is powered to enroll 3380 patients.
  • It aims for superiority in reducing bleeding and non-inferiority in preventing ischemic events.
  • Results will inform clinical practice regarding antiplatelet therapy duration after TAVR.

Conclusions:

  • The CREATE trial will provide crucial evidence on the optimal duration of antiplatelet therapy after TAVR.
  • Findings will guide clinical decision-making for patients not requiring chronic antithrombotic therapy.
  • The study seeks to balance bleeding risk reduction with prevention of ischemic events.
Abstract

Keywords:
antiplatelet therapyaortic stenosistranscatheter aortic valve replacementtreatment withdrawal

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