Key result
Self-expanding intra-annular TAVR yields similar 5-year survival, stroke rates, and valve function versus commercial valves.
Why the study?
Long-term outcomes of the self-expanding intra-annular Portico transcatheter aortic valve are not known.
Does TAVR with a self-expanding intra-annular valve improve 5-year overall survival, stroke rates, and valve function compared to commercially available valves in patients with severe symptomatic aortic stenosis at high/extreme surgical risk?
RCT
1:1
Yes
Does TAVR with a self-expanding intra-annular valve improve 5-year overall survival, stroke rates, and valve function compared to commercially available valves in patients with severe symptomatic aortic stenosis at high/extreme surgical risk?
p-value: p=0.40
At 5 years, the self-expanding intra-annular Portico valve demonstrated similar survival, stroke rates, and valve function compared to commercially available valves in high/extreme surgical risk patients.
Supports the self-expanding intra-annular valve as a durable TAVR option in high/extreme-risk patients; extends short-term data to confirm 5-year equivalence.
BACKGROUND: Long-term outcomes of the self-expanding intra-annular Portico transcatheter aortic valve are not known. OBJECTIVES: This study aimed to report the 5-year outcomes of the PORTICO IDE randomized controlled trial. METHODS: This multicenter trial randomized (1:1) patients with severe symptomatic aortic stenosis at high/extreme surgical risk to transcatheter aortic valve replacement (TAVR) with the self-expanding intra-annular valve (study valve) or Food and Drug Administration-approved commercially available valves (CAVs; balloon-expandable or self-expanding supra-annular platforms). Assessments of the primary safety endpoint (30 days) and the primary efficacy endpoint (1 year) have been previously reported. Prespecified clinical outcomes and hemodynamic valve parameters are presented through 5 years. RESULTS: , P = 0.40) compared to CAV. CONCLUSIONS: In patients at high or extreme surgical risk, TAVR with the self-expanding intra-annular transcatheter heart valve had similar 5-year overall survival, stroke rates, and valve function compared with commercially available valves.
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Makkar et al. (2026) conducted an RCT in severe symptomatic aortic stenosis. TAVR with self-expanding intra-annular valve vs. Commercially available valves was evaluated on 5-year overall survival, stroke rates, and valve function (p=0.40). TAVR with the self-expanding intra-annular valve had similar 5-year overall survival, stroke rates, and valve function compared with commercially available valves (P=0.40).
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