The PROGRESS Trial: Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

doi:10.1056/NEJMoa2607326

PROGRESS

Patient / Population Intervention / Exposure Comparison Outcome

In patients with moderate aortic stenosis and at-risk features, transfemoral TAVR was superior in reducing death or a heart-failure event at 2 years compared with clinical surveillance.

N

744patients

Design

Prospective, multicentre, open-label randomised trial (Edwards; 80 sites in the US, Canada, Europe, Japan and Australia) of TAVR versus clinical surveillance in moderate aortic stenosis with symptoms or evidence of cardiac damage or dysfunction

Endpoint

Primary effectiveness endpoint at 2 years; primary safety endpoint at 30 days (components not named on the registration)

ResultKaplan-Meier estimate of death from any cause or a heart-failure event at 2 years 16.7% with TAVR vs 23.9% with clinical surveillance (risk difference -7.2 percentage points; 95% CI -13.1 to -1.3; P = 0.02 for superiority). Death from any cause 8.4% vs 7.3%. Heart-failure event 10.8% vs 19.0%. The incidence of procedure-related adverse events did not differ meaningfully between the TAVR group and surveillance patients who underwent aortic-valve replacement.

Généreux P, Makkar RR, et al. N Engl J Med. 2026; published online 2 November. 10.1056/NEJMoa2607326

Discussion & critique

In 744 patients with moderate aortic stenosis and at-risk features, TAVR lowered the 2-year composite of death or a heart-failure event compared with clinical surveillance. Heart-failure events account for the benefit: death from any cause was numerically higher with TAVR (8.4% vs 7.3%), so the trial does not show a survival advantage. The trial was open label and the composite counts heart-failure events with or without hospitalisation, which makes it vulnerable to ascertainment bias. The abstract compares procedural safety only with surveillance patients who went on to valve replacement and gives no event figures, and the trial was funded by Edwards Lifesciences.