TAVR in moderate aortic stenosis: fewer heart-failure events, no fewer deaths at two years

Design

International, open-label randomised trial (PROGRESS)

Population

744 patients, mean age 78, with moderate aortic stenosis and at least one at-risk feature

Primary outcome

Death from any cause or a heart-failure event at 2 years

Effect

16.7% vs 23.9%; risk difference −7.2 points (95% CI −13.1 to −1.3)

PROGRESS was an international, open-label randomised trial of 744 patients with moderate aortic stenosis and at least one at-risk feature, such as symptoms or a structural or functional abnormality linked to faster progression. Mean age was 78, mean valve area 1.2 cm² and peak velocity 3.3 m/s; nearly half were at low surgical risk. Patients were assigned to transfemoral TAVR with a balloon-expandable valve or to surveillance.

At two years, death or a heart-failure event occurred in 16.7% with TAVR and 23.9% with surveillance, a difference of −7.2 percentage points (95% CI −13.1 to −1.3). The benefit came from heart-failure events (10.8% versus 19.0%); all-cause death was 8.4% versus 7.3%. Procedural complications were similar to those in surveillance patients who went on to valve replacement.

Guidelines still recommend surveillance for moderate aortic stenosis, and one industry-funded, open-label trial with a soft, partly subjective component will not change that on its own. What it does support is taking at-risk features seriously: a patient with moderate stenosis plus symptoms or ventricular changes deserves a heart team discussion and closer follow-up, not a two-year echo recall by default.

• Look for at-risk features in moderate aortic stenosis: symptoms, raised natriuretic peptides, reduced ejection fraction or ventricular damage.
• Refer moderate stenosis with at-risk features for a heart team discussion rather than routine two-yearly echo.
• Tell patients the benefit seen was fewer heart-failure events, not longer survival.
• Shorten the echo interval when moderate stenosis is accompanied by symptoms.

Why it matters

It challenges the default that moderate stenosis is simply something to watch until it becomes severe.

Don't overread it

Open-label, device-maker funded, and with no survival difference; the guideline has not changed.

The statistics, in plain English

The 7.2-point difference means about one heart-failure event or death avoided for every 14 patients treated over two years. The interval (−13.1 to −1.3) excludes no effect but is wide, and the upper end is a small gain. Deaths were similar in both groups, so the composite was carried by heart-failure events, which in an open-label trial are more open to judgement than death.

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