Transcatheter Aortic Valve Replacement in Pure Aortic Regurgitation: The Randomized SEASON-AR Clinical Trial

BACKGROUND: For patients with severe pure aortic regurgitation (AR) at high surgical risk, guideline-directed medical therapy (GDMT) is often the only available option. Transfemoral transcatheter aortic valve replacement (TAVR) is an established treatment for aortic stenosis and has also been evaluated in patients with pure AR. However, no adequately powered randomized trial has compared TAVR with GDMT alone in this population. METHODS: We conducted a prospective, investigator-initiated, multicenter, randomized, open-label trial in China. Patients with severe pure AR for whom surgery was considered difficult or unacceptable by the local heart team or who persistently declined surgery were randomly assigned at a 1:1 ratio to receive transfemoral TAVR with the VitaFlow system plus GDMT or GDMT alone. The primary end point was a composite of all-cause death, disabling stroke, or heart failure rehospitalization at 1 year. RESULTS: We assigned 210 patients with severe pure AR to the TAVR group (n=109) or GDMT group (n=101) at 18 centers. At 1-year follow-up, the Kaplan-Meier estimate of the primary end point was significantly lower in the TAVR group than in the GDMT group (8.3% vs 24.8%; hazard ration [HR], 0.31 [95% CI, 0.14–0.66]; P =0.001), driven primarily by a reduction in heart failure rehospitalization (3.7% vs 21.3%; HR, 0.16 [95% CI, 0.06–0.47]; P < 0.001). TAVR was associated with higher rates of major or life-threatening bleeding and new permanent pacemaker implantation, most of which occurred within 30 days after the procedure. CONCLUSIONS: Among patients with severe pure AR, TAVR plus GDMT significantly reduced the rate of all-cause death, disabling stroke, or heart failure rehospitalization at 1 year compared with GDMT alone despite higher 30-day rates of major or life-threatening bleeding and new permanent pacemaker implantation. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04864145