A minimalist strategy of local anesthesia without sedation may be as safe and feasible as a standard-of-care approach that includes conscious sedation for many patients undergoing transcatheter aortic valve implantation (TAVI), according to results of the DOUBLE-CHOICE trial.

The randomized, open-label, multicenter, noninferiority trial also found that the Acurate neo2 transcatheter valve (Boston Scientific) was noninferior to the Evolut family of valves (PRO/PRO+/FX, Medtronic) for the primary composite endpoint at 30 days.

These findings were published in Circulation and presented at the European Society of Cardiology (ESC) Congress 2025 by Mohamed Abdel-Wahab, MD, interventional cardiologist at the Heart Center Leipzig, Leipzig, Germany. 

According to Abdel-Wahab, researchers have not previously performed large randomized trials comparing the feasibility, safety, and efficacy of a minimalist approach, specifically local anesthesia without sedation, with standard of care with local anesthesia plus conscious sedation.

“In addition, randomized comparisons of current-generation self-expanding valves in well-selected anatomic subsets remain scarce,” he said during his presentation.

The study featured a 2 × 2 factorial design in which researchers tested both latest-generation self-expanding transcatheter valves and a minimalist vs a standard-of-care approach to the procedure.

To qualify for inclusion, patients with aortic stenosis had to be not only suitable for TAVI but also have anatomy that was equivalently suitable for both transcatheter heart valve types and transfemoral vascular access, as determined by the Heart Team.

Minimalist Strategy Noninferior to Standard of Care

In the anesthesia strategy analysis, the researchers randomly assigned 752 patients to the minimalist approach or standard of care. The median age was 83 years and 58.5% were women.

The primary endpoint — a composite of death, vascular and bleeding complications, infections requiring antibiotics, and neurologic events at 30 days — occurred in 22.9% of the minimalist arm and 25.8% of the standard-of-care arm (P for noninferiority = .003; P for superiority = .18).

The rates of secondary endpoints — such as cardiovascular mortality, valve-related mortality, and device success — were similar between groups. During the procedure, though, researchers observed a significant increase in self-reported anxiety and stress levels in the minimalist group (P < .001 for both). Approximately 20% of the minimalist group also crossed over to standard of care, mostly due to pain and agitation, according to the study.

In the per-protocol analysis, the primary endpoint was not significantly higher in the standard-of-care arm (25.5% vs 18.9%; P for noninferiority < .001; P for difference = .05), although it was in the as-treated analysis (27.5% vs 19.2%; P for noninferiority < .001; P for difference = .01). However, the partial relation of crossovers to intraprocedural complications could have biased the latter outcome, Abdel-Wahab said.

“A minimalist strategy appears to be feasible, safe, and efficient, although patients are potentially exposed to more discomfort and a higher stress level during the procedure,” Abdel-Wahab said.

Thomas Pilgrim, MD, MSc, associate professor at Inselspital, Bern University Hospital in Bern, Switzerland, said that to successfully perform minimalist TAVI, you need the right setting and the right patient.

“All participating sites in the DOUBLE-CHOICE trial were high-volume centers with experienced Heart Teams and well-established treatment pathways. At the same time, there was a high level of expertise in evaluating clinical risk and anatomical complexity,” said Pilgrim, who served as a discussant for the trial.

“So what I would like to know is what was the number of patients screened for potential study participation but excluded by the Heart Team due to perceived risk and what was the impact of treatment crossover and how can we further reduce the crossover rate of nearly 20%? We need tools to optimize the selection of patients suitable for minimalist TAVI,” he said.

A Comparison of TAVI Devices

For the transcatheter valve analysis, the researchers randomly assigned 835 patients to receive the Acurate neo2 or the Evolut PRO/PRO+/FX.

The rate of the primary endpoint, defined as the composite of death, stroke, moderate or severe aortic regurgitation, and permanent pacemaker implantation at 30 days, was about half as high in the Acurate arm (15.4% vs 30.4%; hazard ratio, 0.47; 95% CI, 0.34-0.64; P for noninferiority < .001; P for difference < .001).

Secondary endpoints such as valve-related mortality, device success, and clinical efficacy were similar in both arms, with the rate of pacemaker implantation serving as the primary driver for the difference in the primary endpoint (Evolut, 26.5% vs Acurate, 11.2%), Abdel-Wahab said.

Pilgrim compared these findings with previous data from the ACURATE IDE trial, in which “rates of permanent pacemaker implantation in the Evolut group were considerably lower compared to pacemaker rates in the DOUBLE-CHOICE trial,” he said. “Also, in the ACURATE IDE trial, there were no differences in hard clinical endpoints at 30 days; those emerged only beyond 30 days of follow-up.”

The Acurate neo2 valve was withdrawn from the market in May 2025.

Adbel-Wahab reported that his hospital received speaker’s honoraria and/or consultancy fees on his behalf from Boston Scientific, Edwards Lifesciences, and Medtronic. Pilgrim reported receiving research grants from Boston Scientific, Edwards Lifesciences, and Medtronic.

Brian Ellis is a freelance writer and editor who lives in Southwest Virginia.