Reardon MJ, Geisler BP, Pietzsch JB, Walton A, Tchétché D, Deeb GM, Yakubov SJ, Popma JJ, for the Evolut Low Risk investigators. Evolut Low Risk trial of self-expanding TAVI vs. SAVR: full 1-year results and economic implications [presentation slides, online]. Late-breaking trial presentation accepted for canceled EuroPCR 2020. Available at: www.crtonline.org/presentation-detail/evolut-low-risk-trial-of-self-expanding-tavi-vs-sa. Accessed July 27, 2020.

Objectives. Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement (SAVR). Using a Bayesian study design, the Evolut Low Risk trial demonstrated that TAVI was noninferior to SAVR for the primary endpoint of the estimated 2-year rate of all-cause mortality or disabling stroke (VARC-2). At the time of the Bayesian analysis, however, just 850 of 1403 as-treated patients had been followed through 1 year. The aim of this updated analysis was to report the 1-year follow-up for the entire as-treated cohort, with a focus on the implications for healthcare costs related to the use of TAVI vs. SAVR among patients at low operative risk.

Methods. Evolut Low Risk is a prospective, international multicenter trial that recruited patients at 86 centers in Australia, Canada, Europe, Japan, New Zealand, and the United States. The primary analysis cohort was made up of as-treated patients, defined as those who underwent attempted transcatheter or surgical implantation of a replacement aortic valve. The 1468 patients with severe aortic valve stenosis at low risk of 30-day mortality were then randomized (1:1) to TAVI with the self-expanding CoreValve, Evolut R, or Evolut PRO valves versus SAVR. Patients were deemed to be at low risk of 30-day mortality based on a local heart team assessment, as confirmed by a national screening committee. Adverse events were adjudicated by a clinical events committee. The Mayo Clinic (Rochester, MN) served as the echocardiographic core laboratory.

Results. This study uses a  health-economic analysis framework to discuss the implications of clinical outcomes and trial-reported resource utilization. Baseline characteristics of the study cohort include a mean age of 74.1 ± 5.8 years for TAVI and 73.6 ± 5.9 years for SAVR; and a Society of Thoracic Surgeons predicted risk of mortality of 1.9 ± 0.6% for both groups. Women made up 36.0% of TAVI and 33.8% of SAVR patients.

At 1 year, the Kaplan Meier (KM) rate of all-cause mortality or disabling stroke was 2.7% among TAVI patients vs. 4.6% among SAVR patients (p = 0.06). All-cause mortality rates were similar between the two treatment groups (2.3% for TAVI vs. 3.0% for SAVR; p = 0.41). The rate of disabling strokes was lower among TAVI patients (0.7% vs. 2.3%; p = 0.02). The composite rate of death, disabling stroke, or heart-failure-related hospitalization was significantly lower among TAVI patients (5.6% vs. 10.2%; p = 0.002). Length of stay for the TAVI cohort was 2.6 ± 2.1 days and for the SAVR cohort was 6.2 ± 3.3 (p < 0.001). The KM rates for heart failure rehospitalization were 3.1% among TAVI patients and 6.4% among SAVR patients (p = 0.006). The rates of aortic valve reintervention were 0.6% after TAVI and 0.5% after SAVR (p = 0.80).

Conclusions. This presentation provided clinical and echocardiographic outcomes, along with health-economic implications, for all patients with completed 1-year follow-up.