Critical review · Jun 2, 2026
DOUBLE-CHOICE: ACURATE neo2 versus Evolut
Feistritzer HJ, Lauten P, Rudolph TK, Rudolph V, Geisler T, Massberg S, et al. Comparison of self-expanding transcatheter heart valves for aortic stenosis: the multicentre, randomised, controlled, non-inferiority DOUBLE-CHOICE trial. EuroIntervention. 2026;22(10):555-565.
doi:10.4244/EIJ-D-26-00001 · 2x2 factorial, open-label, multicenter randomized noninferiority trial (10 centers, Germany), n = 835
Summary
DOUBLE-CHOICE randomized 835 patients with symptomatic severe aortic stenosis, in selected anatomies, to ACURATE neo2 or Evolut PRO/PRO+/FX. The 30-day primary endpoint combined death, stroke, moderate or severe prosthetic regurgitation and pacemaker implantation.
| 30-day outcome | ACURATE neo2 | Evolut |
|---|---|---|
| Primary | 15.4% | 30.4% |
| Death | 2.0% | 2.7% |
| Stroke | 2.4% | 3.0% |
| Moderate or severe regurgitation | 1.3% | 1.7% |
| Pacemaker | 11.2% | 26.5% |
ACURATE neo2 was noninferior, with HR 0.47 (95% CI 0.34 to 0.64) for the primary endpoint. The difference came from pacemakers.
Strengths
- Direct randomized comparison of two self-expanding valves.
- Death, stroke and regurgitation were low and similar in both arms.
Methodological issues
- Evolut pacemaker rate outside the literature. In SMART, 88% women with small annuli, both features that raise pacemaker risk, the Evolut arm had 12.1%. In Optimize PRO, the four-step cusp-overlap technique gave 5.8% against 18.2% without it. Evolut FX sits around 6.7% at 30 days. Every one of these benchmarks is at or below the neo2 rate in this trial.
- Implant depth not reported. Depth relative to the membranous septum and baseline RBBB were independent predictors of pacemaker need in Optimize PRO. The paper does not report depth, the variable that would decide whether the difference comes from the valve or the technique.
- Commissural alignment “attempted”. It was attempted in 67.9% of Evolut cases. Attempted is not achieved, and it is unclear whether it works as a marker of cusp overlap.
- Baseline RBBB imbalanced against neo2. 7.8% with Evolut and 11.9% with neo2, which makes the pacemaker gap harder to explain.
Opinion
To me, the trial probably measures implant technique more than a valve difference. I do not know whether Evolut was implanted deeper than current practice advises.
The comparisons above are cross-trial; the only direct comparison is the randomization inside DOUBLE-CHOICE. The neo2’s 11.2% also runs above its own registries, so both arms ran high. With a SMART-level control, the 15-point gap nearly disappears. With an Optimize PRO-level control, the direction reverses.
A self-expanding valve pacemaker comparison published in 2026 should report implant depth.