Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis: a randomized clinical trial

The UK TAVI Trial Investigators (2022) Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis: a randomized clinical trial. JAMA, 327 (19), 1875-1887. (doi:10.1001/jama.2022.5776).

Record type: Article

Abstract

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.

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UK TAVI Trial - JAMA - Authors Accepted Version 25Mar2022 (002) - Accepted Manuscript

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e-pub ahead of print date: 17 May 2022

Published date: 17 May 2022

Additional Information: Funding Information: and Swiss Precision Diagnostics; being a member of the National Institute for Health and Care Excellence diagnostics advisory committee; and being a National Institute for Health and Care Research senior investigator emeritus. Dr MacCarthy reported proctoring and receiving educational grants and personal fees from Edwards Lifesciences. Dr Prendergast reported receiving unrestricted educational and research grants to his institution from Edwards Lifesciences; receiving speaker fees from Edwards Lifesciences, Medtronic, and Abbott; and receiving consultancy fees from Anteris and Microport. Dr Cleland reported receiving personal fees from Abbott and Medtronic for serving on advisory boards and data and safety monitoring committees; receiving support from Abbott for a health economic analysis of the MitraClip device; nonfinancial support from Boston Scientific (access to data from a clinical trial); and receiving grants to his institution from Medtronic for a trial of a subcutaneous monitoring device. Dr Banning reported receiving an educational grant to his institution from Boston Scientific. Dr Sayeed reported serving as a company director and receiving dividends from Oxford Heart Surgery Ltd. Dr Fraser reported proctoring and receiving personal fees and speaker fees from Medtronic and receiving speaker fees from Edwards Lifesciences. Dr Duncan reported receiving personal fees from Edwards Lifesciences, Medtronic, and Abbott Vascular. Dr Curzen reported receiving grants from Boston Scientific, Haemonetics, Heartflow, and Beckmann Coulter and receiving nonfinancial support from Edwards Lifesciences, Biosensors, and Boston Scientific. Dr Malkin reported receiving personal fees from Medtronic, Abbott, and Boston Scientific. Dr Muir reported receiving personal fees from Edwards Lifesciences and Abbott Vascular. Dr Uren became an employee of Edwards Lifesciences in May 2021 and had no further input in the trial thereafter, apart from confirming approval of the final version of the submitted work. Dr Pessotto reported proctoring and receiving personal fees from Edwards Lifesciences. Dr Khogali reported serving as a consultant and proctor and receiving personal fees from Boston Scientific and Medtronic. Dr Dalby reported proctoring and receiving personal fees from Medtronic and receiving personal fees from Edwards Lifesciences and Boston Scientific. Dr Redwood reported proctoring and receiving personal fees from Edwards Lifesciences and serving as an advisory board member for Medtronic. No other disclosures were reported. Funding Information: National Institute for Health Research Health Technology Assessment Programme (project reference 09/55/63). Additional support was provided by the National Institute for Health Research Clinical Research Network. Excess treatment costs were paid by the NHS England in England, by the National Institute for Social Care and Health Research in Wales, and by the Chief Scientist Office and NHS Research Scotland in Scotland. The transcatheter aortic valves and surgical valves were procured through standard National Health Service commissioning processes. The research governance sponsor for the study was the University of Leicester. Publisher Copyright: © 2022 American Medical Association. All rights reserved.

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