Highlight
– The SEASON-AR trial is the first adequately powered randomized study comparing TAVR plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with severe pure aortic regurgitation (AR) who are high surgical risk or refuse surgery.
– TAVR with the VitaFlow system significantly reduces the composite endpoint of all-cause death, disabling stroke, or heart failure rehospitalization at 1 year versus GDMT alone (8.3% vs 24.8%; HR 0.31; P=0.001).
– The primary driver of benefit was a marked reduction in heart failure rehospitalization.
– TAVR was associated with higher rates of early major or life-threatening bleeding and new permanent pacemaker implantation compared to GDMT.
– These results support TAVR as a valuable treatment option in inoperable severe pure AR, expanding the role of transcatheter therapies beyond aortic stenosis.
Study Background
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