6/28/23, 10:13 PM Evolut low risk Pathway Feedback Search Clinical Topics Home Studies Evolut low risk Evolut low risk Disease Aortic stenosis Trial question Is TAVR noninferior to surgical AVR in low surgical risk patients with severe aortic stenosis? Study design Multi-center Open label RCT Population Characteristics of study participants 35.0% female N = 1403 65.0% male 1403 patients (490 female, 913 male) Inclusion criteria: patients with severe aortic stenosis at low surgical risk Key exclusion criteria: complex coronary artery disease, leukopenia, ventricular dysfunction, hemodynamic or respiratory instability, renal insufficiency, severe lung disease, active liver disease, severe pulmonary hypertension Interventions N=725 TAVR (with a self-expanding supraannular bioprosthesis) N=678 SAVR (with a bioprosthetic valve) Primary outcome Death or disabling stroke at 24 months 6.7 % 6.7 5.3 5.0 % https://web.pathway.md/studies/recZPQQ48b7qoFXLf 1/2 6/28/23, 10:13 PM Evolut low risk Pathway 3.4 % Difference not exceeding nonferiority margin 1.7 % 0.0 % Transcatheter aortic valve replacement Surgical aortic valve replacement Difference not exceeding nonferiority margin in death or disabling stroke at 24 months (5.3% vs. 6.7%; ARD -1.4, 95% CI -4.9 to 2.1) Secondary outcomes No significant difference in aortic valve gradient at 12 months (8.6 mmHg vs. 11.2 mmHg; ARD -2.6, 95% CI -3726.33 to 3721.13) No significant difference in effective orifice areas at 12 months (2.3 cm vs. 2 cm ; ARD 0.3, 95% CI -429.36 to 429.96) Safety outcomes No significant difference in secondary composite safety end point at 30 days (5.3% vs. 10.7%). Conclusion In patients with severe aortic stenosis at low surgical risk, TAVR was noninferior to SAVR with respect to death or disabling stroke at 24 months. Reference Popma JJ, Deeb GM, Yakubov SJ et al. Transcatheter Aortic-Valve Replacement with a Self- Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. Open reference URL https://web.pathway.md/studies/recZPQQ48b7qoFXLf 2/2