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

医学主动脉瓣置换术狭窄主动脉瓣狭窄外科主动脉瓣心脏病学反流（循环）阀门更换内科学随机对照试验

作者

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,Catherine 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,Anna Oommen,Thabitha Charles,Michael McDermott,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,Matthias Szabolcs,Kate Banks,Zoe Nicholas,Sam Gough,Julie Bigg,Judith Radmore,André La Gerche,Benoy N. Shah,David K. Gardner,Daniel J. Blackman,Michael S. 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,V. Suresh,Natasha Wilmshurst,Linda A Zacharkiw,Christopher Allen,Megan Bell,Karen M. Wilson,Mohammad S 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‐Yerga,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 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,J. Kirk Edwards,Elizabeth Hodges,Elizabeth D. Thompson,Patricia A. Thomas,Lesley W. Davies,Gill Arbane,Stephen Hiles,Jacqueline Holder,Sam Bowen,Lona Hanzel,Margaret McEntegart,Nawwar Al‐Attar,Keith G. Oldroyd,Elaine Matthews,Sagar N. Doshi,Jorge Mascaro,Jonathan N. 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,Lachlan McDowell,Cathy Barman,Jane F. Lynch,Anita Macnab,Laura E Dobson,Stephen Brecker,V. Chandrasekaran,Vennessa Sookhoo,Raj Sharma,Susan Brown,Ghada Mikhail,Andrew Chukwuemeka,Iqbal Malik,Jon Anderson,Angela Frame,Jens Mogensen,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,B. J. 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 L. Mills,Ian B. Wilkinson,Stuart M. Cobbe,Wil Woan,Graham Cooper,John J.V. McMurray,Lars Køber,Filippo Crea,Tom Treasure,Ian Ford,Marc Randall,Sanjeev Bhattacharyya,John Dean,Alice Wood,James S. Yeh,Priyanka Batra,Vicki S Barber,Samuel Fatoba,Surjeet Singh,Esther Villarreal,Mark Butler,Alexis B. Webb,J L 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 G.P. Tijssen,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 G. 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,P D Ridley

出处

期刊：JAMA [American Medical Association]
日期：2022-05-17 卷期号：327 (19): 1875-1875 被引量：77

链接

jamanetwork.com nih.gov ac.uk nih.govdoi.org

标识

DOI：10.1001/jama.2022.5776

摘要

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 (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of −2.0% (1-sided 97.5% CI, −∞ to 1.2%;P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]).

Conclusions and Relevance

Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year.

Trial Registration

isrctn.com Identifier:ISRCTN57819173

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