Original Investigation
Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk

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Abstract

Background

In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year.

Objectives

This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial.

Methods

This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis.

Results

Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years.

Conclusions

At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114)

Key Words

aortic stenosis
surgical aortic valve replacement
transcatheter aortic valve replacement

Abbreviations and Acronyms

AS
aortic stenosis
BVF
bioprosthetic valve failure
CI
confidence interval
CT
computed tomography
HR
hazards ratio
HVD
hemodynamic valve deterioration
KCCQ-OS
Kansas City Cardiomyopathy Questionnaire–overall summary
LV
left ventricle
MI
myocardial infarction
MR
mitral regurgitation
PVR
paravalvular regurgitation
STS-PROM
Society of Thoracic Surgeons–predicted risk of operative mortality
TAVR
transcatheter aortic valve replacement
VARC
Valve Academic Research Consortium

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Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.

Bernard Prendergast, BMedSci, BM BS, DM, served as Guest Associate Editor for this paper. Athena Poppas, MD, served as Guest Editor-in-Chief for this paper.

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