6/29/23, 1:37 AM PARTNER B Pathway Feedback Search Clinical Topics Home Studies PARTNER B PARTNER B Disease Aortic stenosis Trial question What is the role of TAVI in patients with severe aortic stenosis who are not suitable candidates for surgical replacement of aortic valve? Study design Multi-center Open label RCT Population Characteristics of study participants 54.0% female N = 358 46.0% male 358 patients (192 female, 166 male) Inclusion criteria: patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery Key exclusion criteria: bicuspid or noncalcified aortic valve, acute myocardial infarction, substantial coronary artery disease requiring revascularization, a LVEF < 20%, severe mitral or AR, TIA or stroke within the previous 6 months, and severe renal insufficiency Interventions N=179 TAVR (transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve) N=179 standard therapy (balloon aortic valvuloplasty plus adjunctive pharmacologic therapy) https://web.pathway.md/studies/recp7BCgy3t27jU5u 1/2 6/29/23, 1:37 AM PARTNER B Pathway Primary outcome Death at 1 year 50.7 % 50.7 38.0 % 30.7 25.4 % Significant decrease 12.7 % NNT = 5 0.0 % Transcatheter aortic valve replacement Standard therapy Significant decrease in death at 1 year (30.7% vs. 50.7%; HR 0.55, 95% CI 0.4 to 0.74) Secondary outcomes Significant decrease in death from any cause or repeat hospitalization (42.5% vs. 71.6%; HR 0.46, 95% CI 0.35 to 0.59) Significant decrease in death from cardiovascular causes at 1 year (20.5% vs. 44.6%; HR 0.39, 95% CI 0.27 to 0.56) Significant decrease in death from any cause or major stroke at 1 year (33% vs. 51.3%; HR 0.58, 95% CI 0.43 to 0.78) Safety outcomes Significant differences in major vascular complications (16.2% vs. 1.1%, p < 0.001). Conclusion In patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, TAVR was superior to standard therapy with respect to death at 1 year. Reference Leon MB, Smith CR, Mack M et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. Open reference URL https://web.pathway.md/studies/recp7BCgy3t27jU5u 2/2