Five-Year Clinical and Echocardiographic Outcomes of the PARTNER 3 Low Risk Randomized Trial—Coverage of TCT 2023 | SCAI

Why is this study important? 

While TAVR has been shown to be generally equivalent or superior to SAVR in low-surgical-risk patients in the short term, a head-to-head comparison of longer-term outcomes in this generally healthier patient population has not been described. 

What question was this study supposed to answer? 

This study was a five-year follow-up of the PARTNER 3 trial, which included ~1000 low surgical risk (STS PROM < 4%) patients with severe aortic stenosis randomized to TAVR vs. SAVR with the Sapien 3 valve system. 

What did the study show?

The primary outcome (five-year death, stroke, or rehospitalization) was similar between TAVR (22.8%) and SAVR (27.2%) randomized patients (p = 0.07). This reflected better outcomes with TAVR as compared to SAVR at one year (8.5% vs. 15.6%, HR 0.52, CI 0.36-0.76 p = 0.001) combined with similar outcomes between TAVR and SAVR between years one and five (15.7% vs. 13.7%, HR 1.17, CI 0.81-1.70). The restricted mean event-free survival was 103 days (95% CI 26 -180) longer with TAVR than with SAVR. Quality of life was also similar at five years, with KCCQ-OS scores of 86.2 in the TAVR group compared to 85.9 in the SAVR group. 

Echocardiographic outcomes at five years showed similar mean aortic valve gradients (12.7+/-6.5% vs. 11.7 +/- 5.6% mmHg), as well as bioprosthetic valve failures (3.3% vs. 3.8%) in the TAVR and SAVR randomized patients.

In summary, TAVR with Sapien 3 in low surgical risk patients with severe aortic stenosis results in similar major clinical outcomes as SAVR, with similar valve performance and no evidence of poorer valve durability.