TAVR Low-Risk 4-5 Year Data Trial | SCAI

Why is this study important? 

Prior studies have shown equivalent or superior outcomes with transcatheter aortic valve replacement (TAVR) compared to surgical aortic-valve replacement (SAVR) among patients with severe, symptomatic aortic stenosis who were at low surgical risk. However, long-term outcomes with TAVR in low surgical risk patients were not known. 

What question was this study supposed to answer? 

The goal of these two studies was to assess the long-term (4-years for self-expanding CoreValve and 5-years for SAPIEN 3 transcatheter heart valve) safety and efficacy of TAVR compared to SAVR in low-risk patients. 

What did the study show? 

In 5-year follow-up of the 1000 patients from PARTNER-3 trial, the primary composite end point of death, stroke, or rehospitalization was similar in TAVR and SAVR group (22.8% in the TAVR group and 27.2% in SAVR; 95% confidence interval [CI], −9.9 to 1.3; P=0.07). During the 5-year follow-up period, the restricted mean event-free survival time was longer in the TAVR group compared to SAVR group by 103 days (95% CI 26 -180); this was primarily driven by the difference in rehospitalization between TAVR and SAVR groups. Quality of life as assessed by the KCCQ-OS score was also similar between the two groups (score of 86.2 in the TAVR group and 85.9 in SAVR group). The hemodynamic performance of the prosthetic valve and bioprosthetic valve failures were also similar in TAVR and SAVR groups (Mean valve gradient 12.8±6.5 vs. 11.7±5.6; valve failure 3.3% vs. 3.8%) at 5-year. 

From 1,414 patients who underwent aortic valve implantation in Evolut Low Risk trial, 4-year outcome data was reported for ~95% of TAVR patients and ~89% of SAVR patients. The primary composite endpoint of death or disabling stroke was 10.7% in TAVR and 14.1% for SAVR (Hazard ratio, 0.74; 95% CI, 0.54-1.00; P = .05), resulting in a 26% relative reduction in hazard of all-cause mortality or disabling stroke with TAVR compared to SAVR. The difference in the two groups continued to expand over time (-3.4% at 4-year compared to -1.8% at 1-year). Furthermore, the valve hemodynamics was significantly better in TAVR group compared to SAVR group [mean gradient: 9.8 vs. 12.1 (p < 0.001); aortic valve area 2.1 vs. 2.0 cm2 (p < 0.001); none/trace paravalvular leak: 84.7% vs. 98.4% (p < 0.05)]. 

In summary, among low surgical risk patients who underwent TAVR with Sapien 3 have similar clinical outcomes and valve performance compared to SAVR at 5-year follow-up. In low surgical risk patients who underwent TAVR with self-expanding CoreValve, there was 26% relative reduction in hazard of death or disabling stroke compared to SAVR, and the difference between two groups continued to increase over time. 

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