Rationale and Design of the REPEAT Trial: A Multicenter Randomized Trial Comparing Redo Surgical Aortic Valve Replacement to Valve‐in‐Valve Transcatheter Aortic Valve Replacement

Abstract

Background Redo surgical aortic valve replacement (rSAVR) has for long been the therapeutic reference standard for degenerated surgical aortic bioprostheses. Valve‐in‐valve transcatheter aortic valve replacement (ViV‐TAVR) has emerged as an alternative for patients at high surgical risk due to its lower invasiveness. The long‐term clinical efficacy of ViV‐TAVR in patients at low to intermediate surgical risk remains unknown. Methods and Results To compare clinical outcomes of redo surgical aortic valve replacement versus ViV‐TAVR in low‐ to intermediate‐risk patients with degenerated surgical aortic bioprostheses. REPEAT (Repeat Intervention for Deteriorated Surgical Bioprosthetic Aortic Valves) is an investigator‐initiated, international, multicenter, randomized, parallel, open‐label trial. A total of 890 patients aged <75 years with a failed surgical aortic bioprosthesis due to structural valve degeneration and low to intermediate surgical risk (ie, Society of Thoracic Surgeons predicted risk of death of <8%) will be randomly assigned in a 1:1 ratio to either redo surgical aortic valve replacement or ViV‐TAVR. The primary end point of REPEAT is a composite of all‐cause death, stroke (including both disabling and nondisabling), myocardial infarction, and rehospitalization for heart failure or aortic valve reintervention at 5 years, based on Valve Academic Research Consortium‐3 definitions. Secondary end points include each of the individual components of the primary composite end point, Valve Academic Research Consortium‐3–based conduction disturbances and arrhythmia, Valve Academic Research Consortium‐3–based wound and bleeding complications, functional status (ie, 6‐minute walk test, Kansas City Cardiomyopathy questionnaire), and treatment costs. Conclusions The REPEAT trial has been designed to test the hypothesis that redo surgical aortic valve replacement is superior to ViV‐TAVR regarding clinical outcomes at 5 years in patients with degenerated surgical aortic bioprostheses and low to intermediate surgical risk.

Keywords

• aortic stenosis
• failed surgical aortic bioprosthesis
• redo surgical aortic valve replacement
• valve‐in‐valve transcatheter aortic valve replacement
• structural valve deterioration