Evolut Low Risk: TAVR Continues to Show Durable Outcomes at 4 Years, Compared With SAVR

At four years, patients enrolled in the Evolut Low Risk trial who underwent TAVR continue to show “durable outcomes” for the primary endpoint of death or disabling stroke, as well as significantly better hemodynamics, compared with patients who underwent surgical aortic valve replacement (SAVR), according to research presented Oct. 24 during TCT 2023 and published simultaneously in JACC.

The Evolut Low Risk trial initially enrolled 1,414 patients (median age of 74 years) who were randomized to either TAVR (n=730) or SAVR (n=684). At four years, data from 94.7% of TAVR patients and 89.2% of SAVR patients was available for analysis.

Overall findings found the primary endpoint at four years was 10.7% in the TAVR group and 14.1% in the SAVR group (HR: 0.74; 95% CI: 0.54-1.00; p=0.05), representing a 26% relative reduction in hazard for death or disabling stroke with TAVR vs. SAVR. According to Michael J. Reardon, MD, FACC, who presented the findings, this difference between groups expanded over time.

In other findings, the composite of all-cause mortality, disabling stroke, or aortic valve rehospitalization was significantly lower with TAVR compared with SAVR (18% vs. 22.4%) and aortic valve rehospitalization was slightly lower at 10.3% in the TAVR group compared with 12.1% in the SAVR group. TAVR patients also had sustained improvement in hemodynamics as measured by echocardiography, with significantly lower aortic valve mean gradients and greater effective orifice area, researchers said.

Additionally, 84.7% of TAVR patients had no/trace paravalvular regurgitation (PVR) at four years compared with 98.4% of SAVR patients. However, there was no difference between the two groups in moderate or greater PVR. Reardon and colleagues also noted that indicators of valve performance including aortic valve reintervention, clinical or subclinical valve thrombosis, and valve endocarditis were similarly low between groups and highlighted that new permanent pacemaker implantation was significantly higher in the TAVR group (24.6%) compared with SAVR (9.9%).

“The difference in all-cause mortality or disabling stroke seen early in the Evolut Low Risk trial continues to diverge in favor of TAVR …” researchers said. “As seen in most transcatheter trials, there was greater loss to follow-up with surgery in this trial, which is a potential limitation of this and similar studies. However, these results provide an important update on intermediate-term outcomes in the low-risk population, and continued follow-up through 10 years will be critical for monitoring long-term valve durability and performance.”

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease

Keywords: Transcatheter Cardiovascular Therapeutics, TCT23, Stenosis, Aortic Disease

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