- Design
- Multicentre randomised open-label trial
- Population
- 210 patients with severe pure aortic regurgitation unsuitable for or declining surgery
- Primary outcome
- 1-year death, disabling stroke or heart failure rehospitalisation
- Effect
- 8.3% vs 24.8%; HR 0.31 (95% CI 0.14–0.66)
SEASON-AR, an investigator-initiated open-label trial at 18 centres in China, randomised 210 patients with severe pure aortic regurgitation, for whom surgery was judged difficult or unacceptable or who declined it, to transfemoral TAVR with a dedicated valve plus medical therapy, or medical therapy alone.
At one year the composite of death, disabling stroke or heart failure rehospitalisation occurred in 8.3% with TAVR and 24.8% with medical therapy (HR 0.31). Most of the difference came from heart failure admissions, 3.7% versus 21.3%. TAVR brought more major or life-threatening bleeding and more new pacemakers, mostly in the first 30 days.
Pure regurgitation has been hard for TAVR because the annulus is often not calcified, so valves anchor poorly. This is the first adequately powered randomised evidence that a transcatheter route helps patients who would otherwise get only drugs.
It does not challenge surgery for operable patients. The trial was open-label, the main gain was in a softer end point, follow-up is one year, and results apply to the valve system tested. Patients turned down for surgery are the group to discuss with a heart team.
- Refer patients with severe pure aortic regurgitation who are declined for surgery to a heart team that offers transcatheter options.
- Keep surgical valve replacement as the standard for operable patients; this trial did not compare against it.
- Counsel patients that early bleeding and pacemaker need were higher after TAVR.
- Ask which valve platform a centre uses, since the trial used one designed for this anatomy.
Why it matters
It gives patients previously left with medical therapy alone a tested alternative.
Don't overread it
One year of open-label data with one valve does not show TAVR rivals surgery for operable patients.
The statistics, in plain English
A hazard ratio of 0.31 means about a two-thirds lower rate of the composite over the year. The confidence interval (0.14 to 0.66) is wide because events were few, so the true effect could be smaller. Most of the benefit came from hospital admissions, which are more open to bias in an unblinded trial than death or stroke.
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