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Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis
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(2022) Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis. JAMA, 327 (19). pp. 1875-1887. doi:10.1001/jama.2022.5776 ISSN 0098-7484.
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Official URL: https://doi.org/10.1001/jama.2022.5776
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
| Item Type: | Journal Article | ||||||
|---|---|---|---|---|---|---|---|
| Divisions: | Faculty of Science, Engineering and Medicine > Science > Statistics | ||||||
| SWORD Depositor: | Library Publications Router | ||||||
| Journal or Publication Title: | JAMA | ||||||
| Publisher: | American Medical Association | ||||||
| ISSN: | 0098-7484 | ||||||
| Official Date: | 17 May 2022 | ||||||
| Dates: |
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| Volume: | 327 | ||||||
| Number: | 19 | ||||||
| Page Range: | pp. 1875-1887 | ||||||
| DOI: | 10.1001/jama.2022.5776 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Free Access (unspecified licence, 'bronze OA') | ||||||
| Copyright Holders: | © 2022 American Medical Association. All rights reserved. | ||||||
| Contributors: |
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