An unnecessary farewell? Drawing "accurate" lessons from DOUBLE-CHOICE

Several randomised head-to-head comparisons of transcatheter heart valves (THV) for the treatment of severe aortic stenosis have been conducted over the past decade, yet data comparing contemporary self-expanding platforms in anatomically selected populations remain limited.

In this issue of EuroIntervention, Feistritzer et al provide important insights from the valve-comparison arm of the DOUBLE-CHOICE trial, which has demonstrated, for the first time, non-inferiority of the ACURATE neo2 valve (Boston Scientific) compared with another contemporary THV.1

This finding contrasts with prior randomised trials, including ACURATE IDE, in which non-inferiority was not achieved.2 As such, DOUBLE-CHOICE contributes to the ongoing discussion in transcatheter aortic valve implantation (TAVI), debating the importance of patient selection, implantation technique, device design, and comparative outcomes.

DOUBLE-CHOICE was an investigator-initiated, multicentre, open-label randomised trial conducted at 10 German centres. The valve-comparison arm enrolled 835 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI, randomised to either the ACURATE neo2 or to an Evolut PRO/PRO+/FX (Medtronic) valve. The primary endpoint was a composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days, with...