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Transcatheter versus surgical aortic valve replacement in lower-risk and higher-risk patients: a meta-analysis of randomized trials
Additional randomized clinical trial (RCT) data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) is available, including longer term follow-up. A meta-analysis comparing TAVI to SAVR was performed. A pragmatic risk classification was applied, par...
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Published in: | European heart journal 2023-03, Vol.44 (10), p.836-852 |
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creator | Ahmad, Yousif Howard, James P Arnold, Ahran D Madhavan, Mahesh V Cook, Christopher M Alu, Maria Mack, Michael J Reardon, Michael J Thourani, Vinod H Kapadia, Samir Thyregod, Hans Gustav Hørsted Sondergaard, Lars Jørgensen, Troels Højsgaard Toff, William D Van Mieghem, Nicolas M Makkar, Raj R Forrest, John K Leon, Martin B |
description | Additional randomized clinical trial (RCT) data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) is available, including longer term follow-up. A meta-analysis comparing TAVI to SAVR was performed. A pragmatic risk classification was applied, partitioning lower-risk and higher-risk patients.
The main endpoints were death, strokes, and the composite of death or disabling stroke, occurring at 1 year (early) or after 1 year (later). A random-effects meta-analysis was performed. Eight RCTs with 8698 patients were included. In lower-risk patients, at 1 year, the risk of death was lower after TAVI compared with SAVR [relative risk (RR) 0.67; 95% confidence interval (CI) 0.47 to 0.96, P = 0.031], as was death or disabling stroke (RR 0.68; 95% CI 0.50 to 0.92, P = 0.014). There were no differences in strokes. After 1 year, in lower-risk patients, there were no significant differences in all main outcomes. In higher-risk patients, there were no significant differences in main outcomes. New-onset atrial fibrillation, major bleeding, and acute kidney injury occurred less after TAVI; new pacemakers, vascular complications, and paravalvular leak occurred more after TAVI.
In lower-risk patients, there was an early mortality reduction with TAVI, but no differences after later follow-up. There was also an early reduction in the composite of death or disabling stroke, with no difference at later follow-up. There were no significant differences for higher-risk patients. Informed therapy decisions may be more dependent on the temporality of events or secondary endpoints than the long-term occurrence of main clinical outcomes. |
doi_str_mv | 10.1093/eurheartj/ehac642 |
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The main endpoints were death, strokes, and the composite of death or disabling stroke, occurring at 1 year (early) or after 1 year (later). A random-effects meta-analysis was performed. Eight RCTs with 8698 patients were included. In lower-risk patients, at 1 year, the risk of death was lower after TAVI compared with SAVR [relative risk (RR) 0.67; 95% confidence interval (CI) 0.47 to 0.96, P = 0.031], as was death or disabling stroke (RR 0.68; 95% CI 0.50 to 0.92, P = 0.014). There were no differences in strokes. After 1 year, in lower-risk patients, there were no significant differences in all main outcomes. In higher-risk patients, there were no significant differences in main outcomes. New-onset atrial fibrillation, major bleeding, and acute kidney injury occurred less after TAVI; new pacemakers, vascular complications, and paravalvular leak occurred more after TAVI.
In lower-risk patients, there was an early mortality reduction with TAVI, but no differences after later follow-up. There was also an early reduction in the composite of death or disabling stroke, with no difference at later follow-up. There were no significant differences for higher-risk patients. Informed therapy decisions may be more dependent on the temporality of events or secondary endpoints than the long-term occurrence of main clinical outcomes.</description><identifier>ISSN: 0195-668X</identifier><identifier>EISSN: 1522-9645</identifier><identifier>DOI: 10.1093/eurheartj/ehac642</identifier><identifier>PMID: 36660821</identifier><language>eng</language><publisher>England</publisher><subject>Aortic Valve - surgery ; Aortic Valve Stenosis ; Heart Valve Prosthesis Implantation - methods ; Humans ; Randomized Controlled Trials as Topic ; Risk Factors ; Stroke - epidemiology ; Stroke - etiology ; Treatment Outcome</subject><ispartof>European heart journal, 2023-03, Vol.44 (10), p.836-852</ispartof><rights>The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c338t-87ec90d60e72ad3cb34c595d73fe99c32e9649a1885e0297902677a692c4b79c3</citedby><cites>FETCH-LOGICAL-c338t-87ec90d60e72ad3cb34c595d73fe99c32e9649a1885e0297902677a692c4b79c3</cites><orcidid>0000-0002-0026-3391 ; 0000-0002-0430-3020 ; 0000-0002-9385-8318 ; 0000-0002-2732-1205 ; 0000-0002-9989-6331 ; 0000-0002-1364-8055 ; 0000-0002-7597-0170 ; 0000-0002-2880-6132 ; 0000-0001-5631-4496</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36660821$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ahmad, Yousif</creatorcontrib><creatorcontrib>Howard, James P</creatorcontrib><creatorcontrib>Arnold, Ahran D</creatorcontrib><creatorcontrib>Madhavan, Mahesh V</creatorcontrib><creatorcontrib>Cook, Christopher M</creatorcontrib><creatorcontrib>Alu, Maria</creatorcontrib><creatorcontrib>Mack, Michael J</creatorcontrib><creatorcontrib>Reardon, Michael J</creatorcontrib><creatorcontrib>Thourani, Vinod H</creatorcontrib><creatorcontrib>Kapadia, Samir</creatorcontrib><creatorcontrib>Thyregod, Hans Gustav Hørsted</creatorcontrib><creatorcontrib>Sondergaard, Lars</creatorcontrib><creatorcontrib>Jørgensen, Troels Højsgaard</creatorcontrib><creatorcontrib>Toff, William D</creatorcontrib><creatorcontrib>Van Mieghem, Nicolas M</creatorcontrib><creatorcontrib>Makkar, Raj R</creatorcontrib><creatorcontrib>Forrest, John K</creatorcontrib><creatorcontrib>Leon, Martin B</creatorcontrib><title>Transcatheter versus surgical aortic valve replacement in lower-risk and higher-risk patients: a meta-analysis of randomized trials</title><title>European heart journal</title><addtitle>Eur Heart J</addtitle><description>Additional randomized clinical trial (RCT) data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) is available, including longer term follow-up. A meta-analysis comparing TAVI to SAVR was performed. A pragmatic risk classification was applied, partitioning lower-risk and higher-risk patients.
The main endpoints were death, strokes, and the composite of death or disabling stroke, occurring at 1 year (early) or after 1 year (later). A random-effects meta-analysis was performed. Eight RCTs with 8698 patients were included. In lower-risk patients, at 1 year, the risk of death was lower after TAVI compared with SAVR [relative risk (RR) 0.67; 95% confidence interval (CI) 0.47 to 0.96, P = 0.031], as was death or disabling stroke (RR 0.68; 95% CI 0.50 to 0.92, P = 0.014). There were no differences in strokes. After 1 year, in lower-risk patients, there were no significant differences in all main outcomes. In higher-risk patients, there were no significant differences in main outcomes. New-onset atrial fibrillation, major bleeding, and acute kidney injury occurred less after TAVI; new pacemakers, vascular complications, and paravalvular leak occurred more after TAVI.
In lower-risk patients, there was an early mortality reduction with TAVI, but no differences after later follow-up. There was also an early reduction in the composite of death or disabling stroke, with no difference at later follow-up. There were no significant differences for higher-risk patients. 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A meta-analysis comparing TAVI to SAVR was performed. A pragmatic risk classification was applied, partitioning lower-risk and higher-risk patients.
The main endpoints were death, strokes, and the composite of death or disabling stroke, occurring at 1 year (early) or after 1 year (later). A random-effects meta-analysis was performed. Eight RCTs with 8698 patients were included. In lower-risk patients, at 1 year, the risk of death was lower after TAVI compared with SAVR [relative risk (RR) 0.67; 95% confidence interval (CI) 0.47 to 0.96, P = 0.031], as was death or disabling stroke (RR 0.68; 95% CI 0.50 to 0.92, P = 0.014). There were no differences in strokes. After 1 year, in lower-risk patients, there were no significant differences in all main outcomes. In higher-risk patients, there were no significant differences in main outcomes. New-onset atrial fibrillation, major bleeding, and acute kidney injury occurred less after TAVI; new pacemakers, vascular complications, and paravalvular leak occurred more after TAVI.
In lower-risk patients, there was an early mortality reduction with TAVI, but no differences after later follow-up. There was also an early reduction in the composite of death or disabling stroke, with no difference at later follow-up. There were no significant differences for higher-risk patients. Informed therapy decisions may be more dependent on the temporality of events or secondary endpoints than the long-term occurrence of main clinical outcomes.</abstract><cop>England</cop><pmid>36660821</pmid><doi>10.1093/eurheartj/ehac642</doi><tpages>17</tpages><orcidid>https://orcid.org/0000-0002-0026-3391</orcidid><orcidid>https://orcid.org/0000-0002-0430-3020</orcidid><orcidid>https://orcid.org/0000-0002-9385-8318</orcidid><orcidid>https://orcid.org/0000-0002-2732-1205</orcidid><orcidid>https://orcid.org/0000-0002-9989-6331</orcidid><orcidid>https://orcid.org/0000-0002-1364-8055</orcidid><orcidid>https://orcid.org/0000-0002-7597-0170</orcidid><orcidid>https://orcid.org/0000-0002-2880-6132</orcidid><orcidid>https://orcid.org/0000-0001-5631-4496</orcidid></addata></record> |
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subjects | Aortic Valve - surgery Aortic Valve Stenosis Heart Valve Prosthesis Implantation - methods Humans Randomized Controlled Trials as Topic Risk Factors Stroke - epidemiology Stroke - etiology Treatment Outcome |
title | Transcatheter versus surgical aortic valve replacement in lower-risk and higher-risk patients: a meta-analysis of randomized trials |
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