Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis

作者：The UK TAVI Trial Investigators, Timothy Fairbairn, Ian Kemp, Andrea S. Young, Christina Ronayne, Janet Barton, J. Crawford Crowe, L. McQuade, Nichola Clarkson, Michail Sionas, Angela Tobin, Sarah Feeney, Deborah E. Dickerson, Jacqueline Currie, Robert D. Shaw, C. Sudarshan, Yasir Abu-Omar, Michael O’Sullivan, William R. Davies, Rebecca McClean, Lisa Wong, Göher Ayman, Bushra S. Rana, Lynne Williams, Rosemary A. Rusk, Rajesh Kharbanda, George Krasopoulos, Jim Newton, Stephanie Lloyd, Deborah Barker, H. L. Naylor, Stuart W Grant, Anu Mary Oommen, Thabitha Charles, Sarah Mackie, Martin Sherwood, Elaine Pickett, James Cockburn, Adam de Belder, Amit Modi, Jessica Parker, Nicola Skipper, Sara Appasamy, Cath Thomson, Ari Gomes, Neil Moat, Cesare Quarto, Rashmi Yadav, Shufang Wang, Teijo Palovaara, Suad Warsama, John Rawlins, Alison Calver, Geoff Tsang, Miskolczi Szabolcs, Karen Banks, Zoe Nicholas, Sam Gough, Julie Bigg, Judith Radmore, Dhrubo Rakhit, Benoy N. Shah, Di Gardner, Daniel J. Blackman, Michael Cunnington, Betsy Evans, Francesco Pirone, Kalyana Javangula, Kathryn Somers, Helen L. Reed, N. Gregory, Dominik Schlosshan, Katrina Bounford, Paul D. Williams, Andrew Goodwin, Sharareh Vahabi, Matthew Jackson, Bilal Bawamia, Stephanie A. Mack, Karen McLeod, Heather Robinson, Bev Atkinson, Nicola Cunningham, Jeetendra Thambyrajah, Sam Middleton, Nick Cruden, Andrew D. Flapan, Vipin Zamvar, Belinda Rif, J. Harrison, Sharon Lockie, Mohammed Akhtar, Steve Hamshere, Neil Roberts, Mervyn Andiapen, Rita Adrego, Delfin Encarnacion, Jonathan Byrne, Ranjit Deshpande, Max Baghai, Michelle Andrews, Abigail Knighton, James Cotton, Heyman Luckraz, Andy Smallwood, Stella Metherell, Raj Das, Azfar Zaman, Kathryn Proctor, U Nwanjo Harrison, Tito Kabir, Vas Panoulas, Claire Prendergast, Paula Rogers, Shelley Rahman Haley, A. Navaneethakrishnan, Tomasz Spyt, M. Hickey, Elved Roberts, Donna Alexander, Elaine Logtens, Derek Chin, Jeffrey Khoo, Anna-Marie Marsh, John McAdam, Marion Campton, Malcolm Dalrymple‐Hay, Venkat Suresh, Natasha Wilmshurst, Linda Zacharkiw, Christopher Allen, Megan Bell, Karen M. Wilson, M. Alam, Ian Massey, J Wain, Rebecca Griffiths, Will Winder, Robert J. Henderson, Surendra Naik, Adam Szafranek, Kamran Baig, Richard Varcoe, Rachel King, Victoria Kozlowski, Sonia Rubie, Andreas Baumbach, Stephen Dorman, Cha Rajakaruna, Laura Gallego, Sheila M. Bell, Ruth Bowles, Laura Wilkinson, Jo Roberts, Mandie Townsend, David Smith, Aprim Youhana, Alexander Chase, Pankaj Kumar, Gladdys Thomas, Claire Fagan, Jane Griffiths, Alisa Wallis, Bohdana Bahlay, David H. Roberts, Augustine T.M. Tang, Amal Bose, Vasanthi Vasudevan, Peter Groves, Indu Deglurkar, Richard P. Anderson, Vaseem Farooq, Ayush Khurana, Nick Ossei‐Gerning, Dheeraj Mehta, Richard Wheeler, Helen M. Dyer, Julie Edwards, Elizabeth Hodges, Elizabeth D. Thompson, Patricia A. Thomas, Lesley Davies, Gillian Andrew, Stephen Hiles, Jacqueline Holder, Sam Bowen, Lona Hanzel, Margaret McEntegart, Nawwar Al‐Attar, Keith G. Oldroyd, Elaine Matthews, Sagar N. Doshi, Jorge Mascaro, John Townend, Aaron M. Ranasinghe, Adnan Nadir, Annette Nilsson, Richard P. Steeds, Richard Lévy, Mamta Buch, Isaac Kadir, Jaydeep Sarma, Saqib Chowdhary, Paul Waterworth, Akhila Muthuswamy, Lindsey McDowell, Cathy Barman, Jane F. Lynch, Anita Macnab, Laura E Dobson, Stephen Brecker, Venkatachalam Chandrasekaran, Vennessa Sookhoo, Raj Sharma, Sue Brown, Ghada Mikhail, Andrew Chukwuemeka, Iqbal Malik, Jon Anderson, Angela Frame, Petros Nihoyannopoulos, Thirumaran Rajathurai, Thomas H. Barker, Luke Tapp, Catherine Gibson, Samantha Hyndman, Luke Mahoney, Laura Speke, Lynn Gardener, Ever Grech, Norman Briffa, Ian P. Hall, Govind Chetty, Stefano Forlani, Mel Neville, Kay Hounsley, Laurence O’Toole, Mark S. Spence, Reuben Jeganathan, Colum Owens, Bernie Smith, Nicola Johnston, Inderpaul Birdi, Rajesh Aggarwal, Madelaine Ocampo, Annaliza Sevillano, Johannes Pintacasi, Mahmoud Loubani, Raj Chelliah, Mubarak Chaudhry, Karen Dobbs, Doug Altman, Tim Daniel, G.J. Fancourt, Marjan Jahangiri, Martin Bland, Dawn E. Saunders, Nicholas A. Boon, Ian B. Wilkinson, Stuart M. Cobbe, Wil Woan, Graham Cooper, John J.V. McMurray, Lars Køber, Peter Crean, Tom Treasure, Ian Ford, Marc Randall, Sanjeev Bhattacharyya, John Dean, Abtehale Al-Hussaini, James S. Yeh, Priyanka Batra, Vicki S Barber, Samuel Fatoba, Surjeet Singh, Elena Villarreal, Mark Butler, Alexis B. Webb, Jim Palmer, Lazarina Engonidou, Aimi Hewitt, Virginia Chiocchia, Beverly A. Shirkey, Susan Dutton, Lei Clifton, Mark Forrest, Gladys McPherson, Brian S. Taylor, Keith Pearce, Martin Stout, Andrew K. Whittaker, Katherine Kuyt, Tiago Vasconcelos Fonseca, William D. Toff, David Hildick‐Smith, Jan Kovac, Michael Mullen, Olaf Wendler, Anita Mansouri, Ines Rombach, Keith R. Abrams, Simon Conroy, Marcus Flather, Alastair Gray, Philip MacCarthy, Mark Monaghan, Bernard Prendergast, Simon Ray, Christopher P. Young, David C. Crossman, John G.F. Cleland, Mark de Belder, Peter Ludman, Stephen Jones, Cameron G. Densem, Steven Tsui, Manoj Kuduvalli, Joseph Mills, Adrian Banning, Rana Sayeed, Ragheb Hasan, Douglas Fraser, Uday Trivedi, Simon Davies, Alison Duncan, Nick Curzen, Sunil K. Ohri, Christopher J. Malkin, Pankaj Kaul, Douglas Muir, W. Andrew Owens, Neal Uren, Renzo Pessotto, Simon Kennon, Wael I. Awad, Saib Khogali, Maciej Matuszewski, Richard Edwards, B.C. Ramesh, Miles Dalby, S. G. Raja, Giovanni Mariscalco, Clinton Lloyd, Ian Cox, Simon Redwood, Mark Gunning, Paul Ridley · 发表于：JAMA · 年份：2022 · DOI：10.1001/jama.2022.5776 · 被引用次数：187 · 研究领域：Cardiac Valve Diseases and Treatments、Aortic Disease and Treatment Approaches、Cardiac and Coronary Surgery Techniques

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (medi...