Valvular & structural heart diseaseRandomised controlled trial
Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Noninferiority Trial
- Randomised controlled trial
- investigator-initiated
- 2×2 factorial
- open-label
- multicentre
- non-inferiority
- 10 German sites
Authors' conclusion
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.
Study context
- Population
- Patients with symptomatic AS undergoing transfemoral TAVI
- Participants
- 752 patients
- Comparison
- Minimalist approach vs standard of care for transfemoral TAVI
- Minimalist approach (MA)n = 377
- Standard of care (SoC)n = 375reference
- Primary endpoint
- Composite of:
- All-cause mortality
- Vascular and bleeding complications
- Infection requiring antibiotic therapy
- Neurological events
- Follow-up
- 30 days
Primary result
As reported in the abstract
Rate difference
2.9%
95% one-sided CI −3.4 to 9.3
P = 0.37 for difference
Events by treatment group
MA vs SoC
rate difference 2.9% (95% one-sided CI −3.4 to 9.3); P for difference = 0.37
Further findings
Patient-reported anxiety and stress during the procedure
- Higher in the MA group
Original publication
Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Noninferiority Trial. Circulation. Published 29 August 2025. doi:10.1161/circulationaha.125.076557
Summarised from the published abstract; every number is checked against it