TAVR with the SAPIEN 3 valve resulted in similar 10-year all-cause mortality compared to surgery in intermediate-risk patients (83.4% vs 82.3%; HR 1.01; 95% CI 0.91-1.13; P=0.82).
Cohort (n=2,005)
Yes
Does TAVR with the SAPIEN 3 valve result in similar 10-year all-cause mortality and reintervention rates compared to surgery in intermediate-risk patients with symptomatic severe aortic stenosis?
At 10 years, TAVR with the SAPIEN 3 valve demonstrates comparable all-cause mortality, reintervention rates, and hemodynamics to surgical aortic valve replacement in intermediate-risk patients with severe aortic stenosis.
Hazard Ratio: 1.01 (95% CI 0.91–1.13)
Absolute Event Rate: 83.4% vs 82.3%
p-value: p=0.82
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for patients with symptomatic severe aortic stenosis. However, long-term outcomes data are lacking for TAVR, particularly with newer-generation transcatheter heart valves. OBJECTIVES: The purpose of this study was to compare 10-year outcomes of intermediate-risk patients who underwent TAVR with the third-generation, balloon-expandable SAPIEN 3 valve in the PARTNER 2 SAPIEN 3 Intermediate-risk Registry (P2S3i) with those who underwent surgery in the PARTNER 2A (P2A) randomized trial. METHODS: Intermediate-risk patients were enrolled in the P2A trial from 2011 through 2013 and in the P2S3i registry in 2014. These prospective, multicenter studies used the same eligibility criteria and stratified patients based on suitability for transfemoral or transthoracic (transapical/transaortic) access. Ten-year outcomes were evaluated, including all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. Patient reconsent was required at 5 years for extended 10-year follow-up, and vital status sweeps were implemented to improve data completeness for all-cause mortality. To account for potential baseline differences and reduce confounding, P2S3i TAVR patients were propensity score-matched 1:1 to P2A surgical patients. RESULTS: Among 2,005 patients who received a valve, 1,069 underwent TAVR in P2S3i and 936 underwent surgery in P2A. After propensity score matching (N = 783 patients in each group), baseline characteristics were similar between groups: mean age was approximately 82 years, 43% were female, and mean Society of Thoracic Surgeons score was 5.5%. At 10 years, all-cause mortality rate was 83.4% after TAVR and 82.3% after surgery, respectively (HR: 1.01 95% CI: 0.91-1.13; P = 0.82). Aortic valve reintervention rates adjusted for competing mortality were 2.0% for TAVR and 1.9% for surgery (P = 0.47). Among 32 TAVR and 30 surgical patients with available echocardiographic data at 10 years, mean gradients were 11.0 mm Hg and 12.6 mm Hg, respectively. CONCLUSIONS: At 10 years, TAVR with the SAPIEN 3 valve and surgery resulted in similar rates of mortality and aortic valve reintervention, and similar hemodynamics in intermediate-risk patients with symptomatic severe aortic stenosis. This analysis highlights challenges associated with extended long-term follow-up of clinical trials, including differential loss to follow-up and the competing risk of mortality in elderly populations. (PARTNER 2A Trial; NCT01314313; PARTNER 2 SAPIEN 3 Intermediate-Risk Registry; NCT03222128).
“Taken together, the studies show a likely early advantage of TAVR with respect to the important primary clinical endpoints, with a later catch-up of surgery, such that there are no major differences between the therapies at 5 years. However, we know that 6 to 10 years and beyond is really the test of time for these valves, and that’s where we’re starting to see some differences emerge.”
Nazif et al. (Mon,) conducted a cohort in symptomatic severe aortic stenosis (n=2,005). TAVR with the SAPIEN 3 valve vs. Surgical aortic valve replacement was evaluated on all-cause mortality (HR 1.01, 95% CI 0.91-1.13, p=0.82). TAVR with the SAPIEN 3 valve resulted in similar 10-year all-cause mortality compared to surgery in intermediate-risk patients (83.4% vs 82.3%; HR 1.01; 95% CI 0.91-1.13; P=0.82).