Key result
Transfemoral TAVR plus GDMT cuts 1-year major events ~69% vs GDMT alone.
Why the study?
For patients with severe pure aortic regurgitation at high surgical risk, guideline-directed medical therapy is often the only available option, and no adequately powered randomized trial had compared transfemoral TAVR with GDMT alone in this population.
Does transfemoral TAVR with the VitaFlow system plus GDMT reduce the composite of all-cause death, disabling stroke, or heart failure rehospitalization at 1 year compared with GDMT alone in patients with severe pure aortic regurgitation?
RCT (n=210)
Open-label
1:1 ratio
Yes
Does transfemoral TAVR with the VitaFlow system plus GDMT reduce the composite of all-cause death, disabling stroke, or heart failure rehospitalization at 1 year compared with GDMT alone in patients with severe pure aortic regurgitation?
In patients with severe pure aortic regurgitation who are ineligible for or decline surgery, transfemoral TAVR plus GDMT significantly reduces the 1-year composite of all-cause death, disabling stroke, or heart failure rehospitalization compared with GDMT alone, despite higher 30-day procedural complication rates.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“for high-risk patients, or patients who are reluctant to receive open-heart surgery, the only way we can treat [them] is GDMT. So, this trial showed that even if a patient is high risk for surgery, if [they are] anatomically suitable, we can safely treat [them] with the TAVR procedure.”
“This study had multiple patient exclusions, about 70%, of course, but certainly showed marked reduction in heart failure hospitalization.”
“The findings support transfemoral TAVR as a potential treatment option for selected patients with severe pure AR who are either at high surgical risk or had firmly declined SAVR.”
Supports TAVR over GDMT in this population; confirms large reduction in death, stroke, or HF rehospitalization.
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
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Gao et al. (2026) conducted an RCT in Severe pure aortic regurgitation (n=210). Transfemoral TAVR with the VitaFlow system plus guideline-directed medical therapy vs. Guideline-directed medical therapy (GDMT) alone was evaluated on Composite of all-cause death, disabling stroke, or heart failure rehospitalization at 1 year (HR 0.31, 95% CI 0.14-0.66, p=0.001). Transfemoral TAVR plus GDMT reduced 1-year all-cause death, disabling stroke, or HF rehospitalization vs GDMT alone (8.3% vs 24.8%; HR 0.31, 95% CI 0.14-0.66; P=0.001).
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