SAPIEN 3 transcatheter aortic valve replacement resulted in similar 5-year rates of death and disabling stroke compared with surgical valve replacement (40.2% vs 42.7%; HR 0.87; 95% CI 0.74-1.03; P=0.10).
RCT (n=1,566)
Hazard Ratio: 0.87 (95% CI 0.74–1.03)
Absolute Event Rate: 40.2% vs 42.7%
p-value: p=0.10
BACKGROUND Previous studies demonstrated transcatheter aortic valve replacement (TAVR) with an earlier generation balloon-expandable valve to be noninferior to surgical aortic valve replacement (SAVR) for death and disabling stroke in intermediate-risk patients with symptomatic, severe aortic stenosis at 5 years. However, limited long-term data are available with the more contemporary SAPIEN 3 (S3) bioprosthesis. OBJECTIVES The aim of this study was to compare 5-year risk-adjusted outcomes in intermediate-risk patients undergoing S3 TAVR vs SAVR. METHODS Propensity score matching was performed to account for baseline differences in intermediate-risk patients undergoing S3 TAVR in the PARTNER 2 (Placement of Aortic Transcatheter Valves) S3 single-arm study and SAVR in the PARTNER 2A randomized clinical trial. The primary composite endpoint consisted of 5-year all-cause death and disabling stroke. RESULTS A total of 783 matched pairs of intermediate-risk patients with severe aortic stenosis were studied. There were no differences in the primary endpoint between S3 TAVR and SAVR at 5 years (40.2% vs 42.7%; HR: 0.87; 95% CI: 0.74-1.03; P = 0.10). The incidence of mild or greater paravalvular regurgitation was more common after S3 TAVR. There were no differences in structural valve deterioration-related stage 2 and 3 hemodynamic valve deterioration or bioprosthetic valve failure. CONCLUSIONS In this propensity-matched analysis of intermediate-risk patients, 5-year rates of death and disabling stroke were similar between S3 TAVR and SAVR. Rates of structural valve deterioration-related hemodynamic valve deterioration were similar, but paravalvular regurgitation was more common after S3 TAVR. Longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability. (PII S3i PARTNER II Trial: Placement of Aortic Transcatheter Valves II - S3 Intermediate, NCT03222128; PII A (PARTNER II Trial: Placement of Aortic Transcatheter Valves II - XT Intermediate and High Risk], NCT01314313).
“This study shows the lowest mortality rate ever of any transcatheter valve platform after one year, which is very exciting for the management of aortic stenosis. A previous analysis by our team showed that almost 20 percent of all patients undergoing surgical aortic valve replacement in the United States are in the intermediate-risk category, so I believe that this could have a major impact on the treatment options we have available for many of these patients.”
Madhavan et al. (Sat,) conducted a rct in symptomatic, severe aortic stenosis (n=1,566). SAPIEN 3 (S3) transcatheter aortic valve replacement vs. Surgical aortic valve replacement (SAVR) was evaluated on composite of 5-year all-cause death and disabling stroke (HR 0.87, 95% CI 0.74-1.03, p=0.10). SAPIEN 3 transcatheter aortic valve replacement resulted in similar 5-year rates of death and disabling stroke compared with surgical valve replacement (40.2% vs 42.7%; HR 0.87; 95% CI 0.74-1.03; P=0.10).