Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement Compared With Surgical Valve Replacement in Intermediate-Risk Patients
Key result
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).
Why the study?
Limited long-term data are available comparing the contemporary SAPIEN 3 bioprosthesis to surgical aortic valve replacement in intermediate-risk patients with symptomatic, severe aortic stenosis.
Key Points
- This trial aims to compare the cardiovascular outcomes of SAPIEN 3 transcatheter aortic valve replacement with surgical valve replacement in intermediate-risk patients.
- Randomized trial involving intermediate-risk patients undergoing valve replacement
- Participants received either SAPIEN 3 transcatheter aortic valve or surgical valve replacement
- Outcomes assessed included various cardiovascular metrics over a specified follow-up period.
- Quality of life scores improved more substantially in the transcatheter group.
Study Design
Type
RCT (n=1,566)
PICO
P
Population
1,566 intermediate-risk patients with symptomatic, severe aortic stenosis followed for 5 years.
I
Intervention / Comparator
SAPIEN 3 (S3) transcatheter aortic valve replacement vs Surgical aortic valve replacement (SAVR)
O
Primary Outcome
composite of 5-year all-cause death and disabling stroke — HR 0.87 (0.74-1.03), p=0.10
Main Result
Hazard Ratio: 0.87 (95% CI 0.74–1.03)
Absolute Event Rate: 40.2% vs 42.7%
p-value: p=0.10
Limitations
- Longer-term follow-up is needed to further evaluate differences in late adverse clinical events and bioprosthetic valve durability.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
“These data comparing real-world outcomes with clinical study results in intermediate-risk patients treated with the Edwards Sapien 3 transcatheter heart valve demonstrated comparably positive outcomes including high survival rates and low rates of stroke.”
“I think it's not unreasonable to consider that both [surgical AVR] and TAVR would be class I, and patients should be informed about the differing risk profiles of the two approaches and certainly about the unknown long-term durability of TAVR before they make a decision.”
Implication
Randomized trial compares cardiovascular outcomes of transcatheter versus surgical valve replacement in intermediate-risk patients, indicating procedural benefits.
Abstract
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).
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Cite This Study
Madhavan et al. (2023) conducted an 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).