Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis

作者：Krithika Loganath, Neil Craig, Russell J. Everett, Rong Bing, Vasiliki Tsampasian, Patrycja Mołek, Simona Botezatu, Saadia Aslam, Steff Lewis, Catriona Graham, Audrey White, Tom MacGillivray, Christopher Tuck, Phillip Rayson, Denise Cranley, S. Rodman Irvine, Ruth Armstrong, Lynsey Milne, Calvin Chin, Graham S. Hillis, Timothy Fairbairn, John P. Greenwood, Richard P. Steeds, Stephen J Leslie, Chim C. Lang, Chiara Bucciarelli‐Ducci, Nikhil Joshi, Vijay Kunadian, Vassilios S. Vassiliou, Jason Dungu, Sandeep S Hothi, Nicholas A. Boon, Sanjay Prasad, Niall Keenan, Dana Dawson, Thomas A. Treibel, Manish Motwani, Christopher A. Miller, Nicholas L. Mills, Ronak Rajani, David P Ripley, Gerry P McCann, Bernard Prendergast, Anvesha Singh, David E. Newby, Marc R. Dweck, EVOLVED investigators, Kush Patel, Mervyn Andiapen, Lucinda Wynne, Hunaid A. Vohra, Jodie Hussain, Kelly Patel, Stephen Dorman, Laura Gallego‐Yerga, Jonaifah Ramirez, Emily Redman, Sofia Matia, Madelaine Ocampo, Annaliza Sevilliano, Gracie Maloney, Amanda Solesbury, Steven Church, Lauren Kittridge, Jovita Rebong, Jacqueline Colnet, Johannes Pintacasi, James H. Morrissey, Aoife Tipping, Stephanie Hunt, Amy Raynsford, Daniel L. Cooke, Dan Sado, Jonathan Byrne, Abigail Knighton, Jonathan Breeze, Michail Sionas, J. Crawford Crowe, Maju Jose, Thabitha Charles, Anu Mary Oommen, Victoria Clegg, April Edwards, Adele Trueman, Rajeev Padjama, Suzanne Higson, Martin Sherwood, Sarah Mackie, Anita McNab, Preetha Mathew, Akhila Muthuswamy, Sujata Blane, Sheetal Crasta, Kathryn Walker, Anne Ankers, Philip McGrouther, Dean J. Miller, Denise O'Donell, Melanie Tolson, Anne Firor Scott, Fiona Hall, Gillian Donaldson, Su Ern Yeoh, Rachael Campbell, Debbie McDonald, Donna Patience, Natasha Corballise, Donna Moore, Mary Ilsley, Iain Matthews, Craig Runnett, Gemma McCafferty, Hayley McKie, Helen Campbell, Patrick A. Calvert, Kat Bullock, Catherine Galloway, Tom Gilbert, L. David Hillis, Nicolas Nikolaidis, James Cotton, Giuseppe Ugo Rescigno, Elizabeth A. Radford, Jeetendra Thambyrajah, Neil Maredia, Ben A. Ward, Rachel Dale, Harish Sharma, Annette Nilsson, Helen Brotherton, Tabassuma Akramul, Kady Hutton, Sonia McDonald, Caroline Dykes, Vikki Timmins, Michael Bubb, K Isaacs, Alastair Mobley, Valerie Harries, Beverley Maclennan, Kashan Ali, Zaid Iskandar, Muhammad Asif Hussain, Marie Callaghan, Margaret Glenwright, Hilary Nailon, Frank Morrow, K. B. Orr, Caitlin Murray, A Geddes, Prudence Miyanza, Patricia Jeram, Danielle Deojee, Colin Berry, Anil Joseph, Robert Sykes, Ammani Brown, Kirsty Fallon, Shaela Doig, Laura Kelly-Corless, Tracey Hopkins, Laura Dymock, R. Woodward, Giles Roditi, Kate Smith‐Miles, Miroslawa Gorecka, Anita Roxas, Petra Bijsterveld, Fiona Richards, R. Jude, Hannah Newman, Emma J. Grant, Kathryn Somers, Lucy Aldridge, Joanne Wormleighton, Jincy Joseph, Xiaobei Zhao, Elaine F. Walker, Lillian Norris, Catherine L'Heureux, Robert Lee, Julia Boyd, Ronald Harkess, Helen Mossop, Nigel Masterton, Douglas W. Young · 发表于：JAMA · 年份：2024 · DOI：10.1001/jama.2024.22730 · 被引用次数：133 · 研究领域：Cardiac Valve Diseases and Treatments、Congenital Heart Disease Studies、Cardiovascular Function and Risk Factors

Importance: Development of myocardial fibrosis in patients with aortic stenosis precedes left ventricular decompensation and is associated with an adverse long-term prognosis. Objective: To investigate whether early valve intervention reduced the incidence of all-cause death or unplanned aortic stenosis-related hospitalization in asymptomatic patients with severe aortic stenosis and myocardial fibrosis. Design, Setting, and Participants: This prospective, randomized, open-label, masked end point trial was conducted between August 2017 and October 2022 at 24 cardiac centers across the UK and Australia. Asymptomatic patients with severe aortic stenosis and myocardial fibrosis were included. The final date of follow-up was July 26, 2024. Intervention: Early valve intervention with transcatheter or surgical aortic valve replacement or guideline-directed conservative management. Main Outcomes and Measures: The primary outcome was a composite of all-cause death or unplanned aortic stenosis-related hospitalization in a time-to-first-event intention-to-treat analysis. There were 9 secondary outcomes, including the components of the primary outcome and symptom status at 12 months. Results: The trial enrolled 224 eligible patients (mean [SD] age, 73 [9] years; 63 women [28%]; mean [SD] aortic valve peak velocity of 4.3 [0.5] m/s) of the originally planned sample size of 356 patients. The primary end point occurred in 20 of 113 patients (18%) in the early intervention group and 25 of 11...