Accès ouvert déclaré 2024 article

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

Krithika Loganath, Neil J. Craig, Russell J. Everett, Rong Bing, Vasiliki Tsampasian, Patrycja Mołek, Simona Botezatu, Saadia Aslam, Steff Lewis, Catriona Graham, Audrey C. White, Tom MacGillivray, Christopher E. Tuck, Phillip Rayson, Denise Cranley, S. Rodman Irvine, Ruth Armstrong, Lynsey Milne, Calvin Chin, Graham S. Hillis, Timothy A. Fairbairn, John Pierre Greenwood, Richard Paul Steeds, Stephen James Leslie, Chim Choy Lang, Chiara Bucciarelli‐Ducci, Nikhil Vilas Joshi, Vijay Kunadian, Vassilios S. Vassiliou, Jason N. Dungu, Sandeep Singh Hothi, Nicholas A. Boon, Sanjay Kumar Prasad, Niall Keenan, Dana K. Dawson, Thomas Alexander Treibel, Manish Motwani, Christopher A. Miller, Nicholas L. Mills, Ronak Rajani, David Paul Ripley, Gerry Patrick McCann, Bernard Prendergast, Anvesha Singh, David Ernest Newby, Marc Richard Dweck, Kush Patel, Mervyn Andiapen, Lucinda Wynne, Hunaid Ahmed Vohra, Jodie Hussain, Kelly Patel, Stephen H. 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, Stephanie Hunt, Amy Raynsford, Daniel L. Cooke, Daniel M. Sado, Jonathan Byrne, Abigail Knighton, Jonathan Breeze, Michail Sionas, J. Crawford Crowe, Thabitha Charles, Anu Mary Oommen, Victoria Clegg, April Edwards, Rajeev Padjama, Suzanne Higson, Martin Sherwood, Sarah Mackie, Preetha Mathew, Akhila Muthuswamy, Sujata Blane, Sheetal Crasta, Kathryn Louise 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 E. McDonald, Donna Patience, Natasha Corballise, Donna Moore, Mary Ilsley, Iain Matthews, Craig Runnett, Gemma L McCafferty, Hayley McKie, Helen Campbell, Patrick A. Calvert, Catherine Galloway, Tom Gilbert, L. David Hillis, Nicolas Nikolaidis, James M. Cotton, Giuseppe Ugo Rescigno, Elizabeth A. Radford, Jeetendra Thambyrajah, Neil Maredia, Ben A. Ward, Rachel Dale, HARISH KUMAR SHARMA, Annette Nilsson, Helen Brotherton, Tabassuma Akramul, Caroline Dykes, Vikki Timmins, Michael Bubb, Karen Isaacs, Alastair Mobley, Kashan Ali, Zaid Iskandar, Muhammad Asif Hussain, Marie Callaghan, Margaret Glenwright, Hilary Nailon, Frank Morrow, K. B. Orr, Caitlin A. Murray, Ailsa Geddes, Prudence Miyanza, Patricia Jeram, Danielle Deojee, Colin Berry, Anil Joseph, Robert Sykes, Ammani Brown, Kirsty Fallon, Shaela Doig, Laura Kelly-Corless, Tracey J. Hopkins, Laura Dymock, R. Woodward, Giles Roditi, Kate Smith‐Miles, Miroslawa Maria Gorecka, Petra Bijsterveld, Fiona Richards, Rosemary Jude, Hannah Newman, Emma J. Grant, Kathryn E. Somers, Joanne V. Wormleighton, Xiaobei Zhao, Elaine F. Walker, Lillian Norris, Catherine L'Heureux, Robert Lee, Julia A. Boyd, Ronald Harkess, Helen Mossop, Nigel Masterton, Douglas W. Young

143Citations signalées, ce qui n’est pas une note de qualité

47Institutions déclarées

6Pays d’affiliation déclarés

Rattachement africain : gb, pl, sg, au, my, us. Niveau de preuve : code pays fourni par la source.

Le résumé fourni par la source

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 111 patients (23%) in the guideline-directed conservative management group (hazard ratio, 0.79 [95% CI, 0.44-1.43]; P = .44; between-group difference, -4.82% [95% CI, -15.31% to 5.66%]). Of 9 prespecified secondary end points, 7 showed no significant difference. All-cause death occurred in 16 of 113 patients (14%) in the early intervention group and 14 of 111 (13%) in the guideline-directed group (hazard ratio, 1.22 [95% CI, 0.59-2.51]) and unplanned aortic stenosis hospitalization occurred in 7 of 113 patients (6%) and 19 of 111 patients (17%), respectively (hazard ratio, 0.37 [95% CI, 0.16-0.88]). Early intervention was associated with a lower 12-month rate of New York Heart Association class II-IV symptoms than guideline-directed conservative management (21 [19.7%] vs 39 [37.9%]; odds ratio, 0.37 [95% CI, 0.20-0.70]). Conclusions and Relevance: In asymptomatic patients with severe aortic stenosis and myocardial fibrosis, early aortic valve intervention had no demonstrable effect on all-cause death or unplanned aortic stenosis-related hospitalization. The trial had a wide 95% CI around the primary end point, with further research needed to confirm these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT03094143.

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Le contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref: Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis
Date Crossref: 21/01/2025
Éditeur: American Medical Association (AMA)
Type: journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.

Où se fait cette recherche

British Heart Foundation pays non établi dans la notice
Organisation à but non lucratif
University of Edinburgh British Heart Foundation Centre of Research Excellence pays non établi dans la notice
Université ou école supérieure
Edinburgh Royal Infirmary pays non établi dans la notice
Établissement de santé
University of East Anglia Norwich Medical School pays non établi dans la notice
Université ou école supérieure
Norfolk and Norwich University Hospital Department of Cardiology pays non établi dans la notice
Établissement de santé
Jagiellonian University Department of Coronary Disease and Heart Failure pays non établi dans la notice
Université ou école supérieure
Corona (Poland) pays non établi dans la notice
Entreprise
University of Leicester Department of Cardiovascular Sciences pays non établi dans la notice
Université ou école supérieure
Glenfield Hospital pays non établi dans la notice
Établissement de santé
NIHR Leicester Biomedical Research Centre pays non établi dans la notice
Structure de recherche
Duke-NUS Medical School pays non établi dans la notice
Université ou école supérieure
National Heart Centre Singapore pays non établi dans la notice
Établissement de santé

British Heart Foundation, British Heart Foundation Centre of Research Excellence — University of Edinburgh et Edinburgh Royal Infirmary, avec 9 autres affiliations.

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Les sujets associés

Cardiac Valve Diseases and TreatmentsCongenital Heart Disease StudiesCardiovascular Function and Risk Factors

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