Rationale and design of the Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure (TAVR UNLOAD) trial

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• 作者：Ernest Spitzer ; MD^a ; ^b ; Nicolas M. Van Mieghem ; MD ; PhD^a ; ^{n.vanmieghem@erasmusmc.nl} ; Philippe Pibarot ; DVM^c ; Rebecca T. Hahn ; MD^d ; ^e ; Susheel Kodali ; MD^d ; ^e ; Mathew S. Maurer ; MD^d ; Tamim M. Nazif ; MD^d ; ^e ; Josep Rodé ; s-Cabau ; MD^c ; Jean-Michel Paradis ; MD^c ; Arie-Pieter Kappetein ; MD ; PhD^a ; Ori Ben-Yehuda ; MD^e ; Gerrit-Anne van Es ; PhD^f ; Faouzi Kallel ; PhD^g ; William N. Anderson ; PhD^h ; Jan Tijssen ; PhD^f ; Martin B. Leon ; MD^d ; ^e
• 刊名：American Heart Journal
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：182
• 期：Complete
• 页码：80-88
• 全文大小：639 K
• 卷排序：182

文摘

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.HypothesisUnloading 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 designThe 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.SummaryThe 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.