Background: Minimalist treatment strategies for transcatheter aortic valve implantation (TAVI) have been widely adopted due to continued procedural evolution, but large randomized trials are lacking. The DOUBLE-CHOICE trial evaluated safety and efficacy of a minimalist approach (MA) compared with standard of care (SoC) for transfemoral TAVI.
Methods: In this investigator-initiated, 2x2 factorial, open-label, randomized, multicenter, non-inferiority trial, patients with symptomatic aortic stenosis were included at 10 German sites. Patients were randomly assigned to MA, including isolated local anesthesia, versus SoC using conscious sedation. The primary endpoint was a composite of all-cause mortality, vascular and bleeding complications, infections requiring antibiotic therapy, and neurologic events at 30 days. Non-inferiority of MA compared with SoC was tested in the intention-to-treat population with an absolute non-inferiority margin of -6% at α-level of 0.05.
Results: Between July 11, 2022, and January 14, 2025, 752 patients were randomly assigned to MA (n=377) and SoC (n=375). The median age was 83 (interquartile range [IQR] 79-86) years, 439 (58.5%) patients were female, and the median Society of Thoracic Surgeons (STS) risk score was 4.6% (IQR 2.9-8.0). The primary endpoint 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% confidence interval [CI] -2.4%, p for non-inferiority 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: MA including isolated local anesthesia was non-inferior to SoC with conscious sedation, highlighting the safety and efficacy of MA for TAVI. The burden of intraprocedural pain and discomfort is potentially higher in the MA group.