6/29/23, 11:57 PM SURTAVI Pathway Feedback Search Clinical Topics Home Studies SURTAVI SURTAVI Disease Aortic stenosis Trial question Is TAVR noninferior to SAVR in patients with severe aortic stenosis who are at intermediate surgical risk? Study design Multi-center Open label RCT Population Characteristics of study participants 43.2% female N = 1746 56.8% male 1746 patients (724 female, 936 male) Inclusion criteria: patients with symptomatic, severe aortic stenosis who are at intermediate surgical risk Key exclusion criteria: refusal for SAVR as a treatment option, contraindication for placement of a bioprosthetic valve, known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, blood dyscrasias, ongoing sepsis, contraindication to extracorporeal assistance, cardiogenic shock or symptomatic carotid or vertebral artery disease Interventions N=864 TAVR (with the use of a self-expanding bioprosthesis) N=796 SAVR (surgical bioprosthesis) https://web.pathway.md/studies/recaUUGRhLehIP2n2 1/2 6/29/23, 11:57 PM SURTAVI Pathway Primary outcome Death or disabling stroke at 24 months 14.0 % 14 12.6 10.5 % 7.0 % Difference not exceeding nonferiority margin 3.5 % 0.0 % Transcatheter aortic valve replacement Surgical aortic valve replacement Difference not exceeding nonferiority margin in death or disabling stroke at 24 months (12.6% vs. 14%; ARD -1.4, 95% CI -5.2 to 2.3) Secondary outcomes No significant difference in death from any cause at 2 years (11.4% vs. 11.6%; ARD -0.2, 95% CI -3.8 to 3.3) Safety outcomes Significant differences in early ( 30 day) AKI stage 2 or 3, new or worsening AF, and the need for transfusion (more common in surgery group) and major vascular complications and the need for permanent pacemaker implantation (more common in TAVR group). Conclusion In patients with symptomatic, severe aortic stenosis who are at intermediate surgical risk, TAVR was noninferior to SAVR with respect to death or disabling stroke at 24 months. Reference Reardon MJ, Van Mieghem NM, Popma JJ et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. Open reference URL https://web.pathway.md/studies/recaUUGRhLehIP2n2 2/2