Cardiology · 3 h ago
SEASON-AR Trial Finds Lower One-Year Events With TAVR for Severe Aortic Regurgitation
In the randomized SEASON-AR trial, 210 patients with severe pure aortic regurgitation and surgery considered difficult or unacceptable were assigned to transfemoral TAVR plus medical therapy or medical therapy alone. At one year, the composite of death, disabling stroke, or heart-failure rehospitalization was less frequent with TAVR, alongside higher rates of major bleeding and pacemaker implantation.
- Randomized trial enrolled 210 patients at 18 Chinese centers.
- One-year composite endpoint: 8.3% with TAVR versus 24.8%.
- Heart-failure rehospitalization was lower with TAVR.
- Bleeding and pacemaker implantation were more frequent after TAVR.
SEASON-AR was a prospective, investigator-initiated, multicenter, open-label randomized trial conducted at 18 centers in China. It enrolled 210 patients with severe pure aortic regurgitation for whom surgery was considered difficult or unacceptable by the heart team, or who persistently declined surgery. Participants were assigned to transfemoral TAVR with the VitaFlow system plus guideline-directed medical therapy (GDMT; n=109) or GDMT alone (n=101). The primary endpoint was all-cause death, disabling stroke, or heart-failure rehospitalization at one year.
The estimated one-year rate of the primary endpoint was 8.3% with TAVR and 24.8% with GDMT alone (hazard ratio, 0.31; 95% CI, 0.14–0.66; P=0.001). The difference was driven mainly by fewer heart-failure rehospitalizations: 3.7% versus 21.3% (hazard ratio, 0.16; 95% CI, 0.06–0.47; P<0.001). Major or life-threatening bleeding and new permanent pacemaker implantation were more frequent after TAVR, mostly within 30 days.
These randomized findings support further consideration of TAVR in this selected population, but the one-year results do not establish broader applicability. The trial was conducted in China and studied a specific TAVR system; the abstract does not provide longer-term outcomes.
In practice
For patients with severe pure aortic regurgitation whose surgery is considered difficult or unacceptable, or who persistently decline surgery, SEASON-AR found fewer one-year deaths, disabling strokes, or heart-failure rehospitalizations with transfemoral TAVR plus medical therapy than with medical therapy alone. The result was driven mainly by fewer heart-failure rehospitalizations. This randomized evidence is clinically relevant but limited to a selected population at Chinese centers, one TAVR system, and one-year follow-up; bleeding and pacemaker implantation were more frequent after the procedure. The findings alone do not establish broader use.
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Circulation: Transcatheter Aortic Valve Replacement in Pure Aortic Regurgitation: The Randomized SEASON-AR Clinical Trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.