The DOUBLE-CHOICE trial is a multicenter, randomized, controlled study conducted in Germany to evaluate the performance of next-generation transcatheter heart valves and different anesthesia strategies in patients with severe aortic stenosis. The study compared two self-expanding platforms: ACURATE neo2 and Evolut PRO/PRO+/FX. In addition, using a 2×2 factorial design, it assessed a minimalist approach based on local anesthesia alone versus standard care.
A total of 836 patients selected by a Heart Team as suitable candidates for both devices were enrolled.
The primary analysis focused on a composite safety and efficacy endpoint that included all-cause mortality, stroke, moderate or severe valvular regurgitation, and permanent pacemaker implantation.
The results showed a significantly lower incidence of the primary endpoint in the ACURATE neo2 group compared with the Evolut group (15.4% vs. 30.4%). This difference was mainly driven by a significant reduction in the need for permanent pacemaker implantation, which occurred in 11.2% of patients treated with ACURATE neo2 compared with 26.5% of those receiving an Evolut valve.
Rates of all-cause mortality were low and comparable between the two groups (2.0% vs. 2.7%), as was the incidence of stroke (2.4% vs. 3.0%). Likewise, moderate or severe prosthetic valve regurgitation was uncommon and similar across both platforms (1.3% for ACURATE neo2 and 1.7% for Evolut).
Prosthesis Design May Influence Preservation of the Cardiac Conduction System
The findings of the DOUBLE-CHOICE trial suggest that, in appropriately selected anatomies, the design of the ACURATE neo2 valve provides important mechanical advantages, particularly in preserving the cardiac conduction system. This translated into a significantly lower need for permanent pacemaker implantation following the procedure, without differences in mortality, stroke, or significant valve regurgitation.
Although the ACURATE program was commercially discontinued for reasons unrelated to its clinical performance, these results highlight the importance of transcatheter valve design characteristics in determining early clinical outcomes. Long-term follow-up, planned for up to 10 years, will help establish the durability and sustained effectiveness of these devices.
Original Title: The DOUBLE-CHOICE trial: ACURATE Neo2 vs EVOLUT TAVI Platforms.
Reference: Hans-Josef Feistheitzer et al EuroIntervention 2026;22:555-565.
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