Ernest Spitzer1, Nicolas M Van Mieghem2, Philippe Pibarot3, Rebecca T Hahn4, Susheel Kodali4, Mathew S Maurer5, Tamim M Nazif4, Josep Rodés-Cabau3, Jean-Michel Paradis3, Arie-Pieter Kappetein6, Ori Ben-Yehuda7, Gerrit-Anne van Es8, Faouzi Kallel9, William N Anderson10, Jan Tijssen8, Martin B Leon4. 1. Erasmus Medical Center, Rotterdam, The Netherlands; Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, The Netherlands. 2. Erasmus Medical Center, Rotterdam, The Netherlands. Electronic address: n.vanmieghem@erasmusmc.nl. 3. Québec Heart & Lung Institute, Laval University, Québec City, Québec, Canada. 4. Columbia University Medical Center, NY; Cardiovascular Research Foundation, NY. 5. Columbia University Medical Center, NY. 6. Erasmus Medical Center, Rotterdam, The Netherlands. 7. Cardiovascular Research Foundation, NY. 8. European Cardiovascular Research Institute, Rotterdam, The Netherlands. 9. Edwards Lifesciences, Irvine, CA. 10. Independent Consultant, Lake Forest, CA.
Abstract
BACKGROUND: Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. HYPOTHESIS: Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. STUDY DESIGN: The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) vs OHFT alone in patients with moderate AS (defined by a mean transaortic gradient ≥20 mm Hg and <40 mm Hg, and an aortic valve area >1.0 cm2 and ≤1.5 cm2 at rest or after dobutamine stress echocardiography) and reduced ejection fraction. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6, and 12 months, and 2 years after randomization. The primary end point is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to HF, symptomatic aortic valve disease or nondisabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at 1 year. Secondary end points capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. SUMMARY: The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of OHFT improves clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. Copyright Â
RCT Entities:
BACKGROUND: Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. HYPOTHESIS: Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. STUDY DESIGN: The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) vs OHFT alone in patients with moderate AS (defined by a mean transaortic gradient ≥20 mm Hg and <40 mm Hg, and an aortic valve area >1.0 cm2 and ≤1.5 cm2 at rest or after dobutamine stress echocardiography) and reduced ejection fraction. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6, and 12 months, and 2 years after randomization. The primary end point is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to HF, symptomatic aortic valve disease or nondisabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at 1 year. Secondary end points capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. SUMMARY: The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of OHFT improves clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. Copyright Â
Authors: Mohammed Y Khanji; Fabrizio Ricci; Victor Galusko; Baskar Sekar; C Anwar A Chahal; Laura Ceriello; Sabina Gallina; Simon Kennon; Wael I Awad; Adrian Ionescu Journal: Eur Heart J Qual Care Clin Outcomes Date: 2021-07-21