Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement.

Abstract

Background: Current guidelines and expert consensus recommend lifelong single antiplatelet therapy for patients undergoing transcatheter aortic valve replacement who have no indication for anticoagulation or dual antiplatelet therapy. However, there is no direct evidence from randomized controlled trials supporting this practice. Furthermore, the optimal duration of antiplatelet therapy in this population has not been adequately investigated.

Methods and results: CREATE (A Multicenter Randomized Controlled Study to Evaluate Cessation of Antithrombotic Therapy at 1 Year in TAVR Patients-The CREATE Study) is a prospective, multicenter, open-label, randomized controlled trial for patients who have undergone successful transcatheter aortic valve replacement and have no indication for long-term oral anticoagulation or antiplatelet therapy. Eligible patients are free from major bleeding and ischemic events for 1 year postprocedure before being randomized 1:1 to single antiplatelet therapy (control group) or no antiplatelet therapy (experimental group). The primary efficacy end point is the incidence of bleeding events, defined by the VARC-3 (Valve Academic Research Consortium-3) criteria, at 1-year postrandomization. The primary safety end point is a composite of cardiac death, myocardial infarction, and ischemic stroke at 1 year. The trial is powered for both superiority in efficiency and noninferiority in safety. Accordingly, a total of 3380 patients will be enrolled.

Conclusions: The CREATE trial aims to assess if stopping antiplatelet therapy at 1-year after transcatheter aortic valve replacement reduces bleeding risk without increasing ischemic events in patients not requiring chronic antithrombotic therapy.

Registration: URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2400087454.