Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Noninferiority Trial

Abstract

BACKGROUND: Minimalist treatment strategies for transcatheter aortic valve implantation have been widely adopted because of continued procedural evolution, but large randomized trials are lacking. The DOUBLE-CHOICE trial (Randomized Study Comparing Both Latest Generation Self-Expanding Valves and a Minimalist Approach Versus Standard of Care in Transcatheter Aortic Valve Implantation) evaluated the safety and efficacy of a minimalist approach (MA) compared with the standard of care (SoC) for transfemoral transcatheter aortic valve implantation. METHODS: In this investigator-initiated, 2×2 factorial, open-label, randomized, multicenter, noninferiority trial, patients with symptomatic aortic stenosis were included at 10 German sites. Patients were randomly assigned to the MA, including isolated local anesthesia, versus the SoC using conscious sedation. The primary end point was a composite of all-cause mortality, vascular and bleeding complications, infection requiring antibiotic therapy, and neurological events at 30 days. The noninferiority of the MA compared with the SoC was tested in the intention-to-treat population with an absolute noninferiority margin of −6% at an α level of 0.05. RESULTS: Between July 11, 2022, and January 14, 2025, 752 patients were randomly assigned to the MA (n=377) and SoC (n=375). The median age was 83 (interquartile range, 79–86) years, 439 (58.5%) patients were women, and the median Society of Thoracic Surgeons risk score was 4.6% (interquartile range, 2.9–8.0). The primary end point occurred in 80 (22.9%) of 350 patients in the MA group and in 91 (25.8%) of 353 patients in the SoC group (rate difference, 2.9%; lower boundary of the 1-sided 95% CI, −2.4%; P for noninferiority=0.003; 2-sided 95% CI, −3.4 to 9.3; P for difference=0.37). Patient-reported anxiety and stress levels during the procedure were higher in the MA group. CONCLUSIONS: The MA including isolated local anesthesia was noninferior to the SoC with conscious sedation, highlighting the safety and efficacy of the MA for transcatheter aortic valve implantation. The burden of intraprocedural pain and discomfort is potentially higher in the MA group. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05036018.