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. 

Other Specialist Resources for Structural Vascular Disease

Including recently published studies, coverage of late-breaking science, updates from clinical trials and registries, and complex case presentations.