EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2026
Comparison of self-expanding transcatheter heart valves for aortic stenosis: the multicentre, randomised, controlled, non-inferiority DOUBLE-CHOICE trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Feistritzer Hans-Josef, Lauten Philipp, Rudolph Tanja K, Rudolph Volker, Geisler Tobias, Massberg Steffen, Adam Matti, Baldus Stephan, Sossalla Samuel, Joner Michael, Moellmann Helge, Wolf Alexander, Kim Won-Keun, Borger Michael A, Noack Thilo, Boening Andreas, Bleiziffer Sabine, Hohenstein Sven, Hoesler Nadine, Buske Maria, Majunke Nicolas, Lankisch Niklas, Roeder Maximilian von, Desch Steffen, Thiele Holger, Abdel-Wahab Mohamed, Of The Double-Choice Investigators On Behalf
Аннотация
BACKGROUND: Although withdrawn from the market, the specific design of the ACURATE neo2 valve might influence the design of future transcatheter aortic valve platforms.
AIMS: We aimed to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) using the ACURATE neo2 valve compared with the Evolut platform in selected anatomies.
METHODS: In this investigator-initiated, 2x2 factorial, open-label, randomised, multicentre, non-inferiority trial, patients with symptomatic, severe aortic stenosis were randomised to the ACURATE neo2 or an Evolut PRO/PRO+/FX valve. The primary endpoint was a composite of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. Non-inferiority of the ACURATE neo2 to an Evolut valve was tested in the intention-to-treat population (absolute non-inferiority margin of -6%, α of 0.05).
RESULTS: At 10 sites in Germany, 835 patients were randomised. Within 30 days, the primary endpoint occurred in 60/389 patients (15.4%) in the ACURATE neo2 group and in 120/395 patients (30.4%) in the Evolut group (rate difference 15.0%, lower boundary of the 1-sided 95% confidence interval [CI]: 10.1%; p for non-inferiority<0.001, 2-sided 95% CI: 9.1-20.7; p for difference<0.001). A permanent pacemaker was implanted in 42/374 patients (11.2%) in the ACURATE neo2 group and in 101/381 patients (26.5%) in the Evolut group (p for difference <0.001). Rates of moderate/severe prosthetic valve regurgitation were low for both valves (1.3% vs 1.7%; p for difference=0.6).
CONCLUSIONS: In selected anatomies, TAVI with the ACURATE neo2 was non-inferior to TAVI with an Evolut valve, with significantly lower rates of the primary endpoint, driven by lower permanent pacemaker implantation at 30 days.
AIMS: We aimed to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) using the ACURATE neo2 valve compared with the Evolut platform in selected anatomies.
METHODS: In this investigator-initiated, 2x2 factorial, open-label, randomised, multicentre, non-inferiority trial, patients with symptomatic, severe aortic stenosis were randomised to the ACURATE neo2 or an Evolut PRO/PRO+/FX valve. The primary endpoint was a composite of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. Non-inferiority of the ACURATE neo2 to an Evolut valve was tested in the intention-to-treat population (absolute non-inferiority margin of -6%, α of 0.05).
RESULTS: At 10 sites in Germany, 835 patients were randomised. Within 30 days, the primary endpoint occurred in 60/389 patients (15.4%) in the ACURATE neo2 group and in 120/395 patients (30.4%) in the Evolut group (rate difference 15.0%, lower boundary of the 1-sided 95% confidence interval [CI]: 10.1%; p for non-inferiority<0.001, 2-sided 95% CI: 9.1-20.7; p for difference<0.001). A permanent pacemaker was implanted in 42/374 patients (11.2%) in the ACURATE neo2 group and in 101/381 patients (26.5%) in the Evolut group (p for difference <0.001). Rates of moderate/severe prosthetic valve regurgitation were low for both valves (1.3% vs 1.7%; p for difference=0.6).
CONCLUSIONS: In selected anatomies, TAVI with the ACURATE neo2 was non-inferior to TAVI with an Evolut valve, with significantly lower rates of the primary endpoint, driven by lower permanent pacemaker implantation at 30 days.