Five-Year Follow-Up of Transcatheter Aortic Valve Replacement With Self-Expanding Intra-Annular Versus Commercially Available Valves.

Abstract

Long-term outcomes of the self-expanding intra-annular Portico transcatheter aortic valve are not known. This study aimed to report the 5-year outcomes of the PORTICO IDE randomized controlled trial. 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. We randomized 750 eligible patients (mean age: 83 years, 52.7% female) to the study valve (n = 381) or CAV (n = 369). Compared with CAV, the study valve showed similar 5-year all-cause mortality or stroke (55.6% vs 51.3%, P = 0.42). Cardiovascular mortality was numerically higher in the study valve group compared with the CAV group (33.4% vs 25.8%; P = 0.06). Naïve permanent pacemaker implantation was higher in the study valve group (36.6%) than the CAV group (20.3%; P < 0.0001) at 5 years. At 5 years, the study valve showed a lower mean transvalvular gradient (7.2 ± 3.0 vs 9.5 ± 6.5 mm Hg, P = 0.008), but similar valve area (1.78 ± 0.45 vs 1.71 ± 0.51 cm², P = 0.40) compared to CAV. 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.