TAVI has become the predominant treatment for severe aortic stenosis. The DOUBLE-CHOICE trial analyzed two key aspects: anesthesia strategy and the type of self-expanding valve.
It was designed as a 2×2 trial, including approximately 800 symptomatic patients eligible for TAVI. One arm compared a minimalist approach (local anesthesia without sedation and minimal instrumentation) versus the standard (conscious sedation and possible central venous access). The other arm evaluated ACURATE neo2 versus Evolut self-expanding valves.
Results showed that the minimalist strategy was non-inferior to the standard approach for the composite endpoint of death, vascular/bleeding complications, infections, and neurological events at 30 days.
Read also: ESC 2025 | DIGIT-HF: Digitoxin in Heart Failure with Reduced Ejection Fraction.
Regarding valves, ACURATE neo2 was non-inferior to Evolut for the primary endpoint (death, stroke, moderate/severe valve regurgitation, or pacemaker implantation), with a significantly lower pacemaker implantation rate. Although ACURATE neo2 was recently withdrawn from the market, researchers emphasized that its design may guide the development of new prosthetic generations.
Presented by Mohamed Abdel-Wahab in Major Late Breaking Trials, ESC 2025, Madrid, Spain.
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