Rong Bing1, Russell J Everett1, Christopher Tuck2, Scott Semple1, Steff Lewis2, Ronnie Harkess2, Nicholas L Mills1, Thomas A Treibel3, Sanjay Prasad4, John P Greenwood5, Gerry P McCann6, David E Newby1, Marc R Dweck7. 1. British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. 2. Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK. 3. Barts Health NHS Trust and University College London, London, United Kingdom. 4. Imperial College London and Royal Brompton Hospital, London, United Kingdom. 5. Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom. 6. Department of Cardiovascular Sciences, University of Leicester, and the NIHR Leicester Biomedical Research Centre, Leicester, United Kingdom. 7. British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. Electronic address: Marc.dweck@ed.ac.uk.
Abstract
BACKGROUND: The optimal timing of aortic valve replacement in asymptomatic patients with aortic stenosis is uncertain. Replacement fibrosis, as assessed by midwall (nonischemic) late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) imaging, is an irreversible marker of left ventricular decompensation in aortic stenosis. Once established, it progresses rapidly and is associated with poor long-term prognosis in a dose-dependent manner. TRIAL DESIGN: The objective of this multicenter prospective randomized controlled trial is to determine whether early aortic valve replacement in asymptomatic patients with severe aortic stenosis can improve the adverse prognosis associated with midwall LGE. Patients will be screened for likelihood of having LGE with electrocardiography or high-sensitivity troponin I. Those at high risk will proceed to CMR imaging. Approximately 400 patients with midwall LGE will be randomized 1:1 to early valve replacement or routine care. Those who do not exhibit midwall LGE will continue with routine care and be randomized to a study registry or no further follow-up. Follow-up will be annual for approximately 3 years until the number of required outcome events is achieved. The primary endpoint is a composite of all-cause mortality and unplanned aortic stenosis-related hospitalization. The expected event rate is 25.0% in the routine care arm and 13.4% in the early intervention arm over the first 2 years; 88 observed primary outcome events will give 90% power at 5% significance level. Key secondary endpoints include all-cause mortality, sudden cardiac death, stroke, and symptomatic status. CONCLUSION: The EVOLVED trial is the first multicenter randomized controlled trial to compare early aortic valve replacement to routine care in asymptomatic patients with severe aortic stenosis and midwall LGE.
BACKGROUND: The optimal timing of aortic valve replacement in asymptomatic patients with aortic stenosis is uncertain. Replacement fibrosis, as assessed by midwall (nonischemic) late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) imaging, is an irreversible marker of left ventricular decompensation in aortic stenosis. Once established, it progresses rapidly and is associated with poor long-term prognosis in a dose-dependent manner. TRIAL DESIGN: The objective of this multicenter prospective randomized controlled trial is to determine whether early aortic valve replacement in asymptomatic patients with severe aortic stenosis can improve the adverse prognosis associated with midwall LGE. Patients will be screened for likelihood of having LGE with electrocardiography or high-sensitivity troponin I. Those at high risk will proceed to CMR imaging. Approximately 400 patients with midwall LGE will be randomized 1:1 to early valve replacement or routine care. Those who do not exhibit midwall LGE will continue with routine care and be randomized to a study registry or no further follow-up. Follow-up will be annual for approximately 3 years until the number of required outcome events is achieved. The primary endpoint is a composite of all-cause mortality and unplanned aortic stenosis-related hospitalization. The expected event rate is 25.0% in the routine care arm and 13.4% in the early intervention arm over the first 2 years; 88 observed primary outcome events will give 90% power at 5% significance level. Key secondary endpoints include all-cause mortality, sudden cardiac death, stroke, and symptomatic status. CONCLUSION: The EVOLVED trial is the first multicenter randomized controlled trial to compare early aortic valve replacement to routine care in asymptomatic patients with severe aortic stenosis and midwall LGE.
Authors: Taishi Okuno; Dik Heg; Jonas Lanz; Stefan Stortecky; Fabien Praz; Stephan Windecker; Thomas Pilgrim Journal: Int J Cardiol Heart Vasc Date: 2021-04-01
Authors: Andreea Calin; Anca D Mateescu; Andreea C Popescu; Rong Bing; Marc R Dweck; Bogdan A Popescu Journal: Heart Date: 2020-03-16 Impact factor: 5.994
Authors: Rong Bing; Haotian Gu; Phil Chowienczyk; Marc R Dweck; Calvin Chin; Lingyun Fang; Audrey White; Russell J Everett; Nicholas B Spath; Eunsoo Park; William Sa Jenkins; Anoop Sv Shah; Nicholas L Mills; Andrew D Flapan; John B Chambers; David E Newby Journal: Heart Date: 2020-04-28 Impact factor: 7.365
Authors: Sophie Paddock; Vasiliki Tsampasian; Hosamadin Assadi; Bruno Calife Mota; Andrew J Swift; Amrit Chowdhary; Peter Swoboda; Eylem Levelt; Eva Sammut; Amardeep Dastidar; Jordi Broncano Cabrero; Javier Royuela Del Val; Paul Malcolm; Julia Sun; Alisdair Ryding; Chris Sawh; Richard Greenwood; David Hewson; Vassilios Vassiliou; Pankaj Garg Journal: Front Cardiovasc Med Date: 2021-07-07