Cargando…

The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials

BACKGROUND: Currently, transcatheter aortic valve implantation (TAVI) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, the efficacy and safety of TAVI have not yet been well evaluated and its noninferiority compared with tradi...

Descripción completa

Detalles Bibliográficos
Autores principales: Zhao, Peng-Ying, Wang, Yong-Hong, Liu, Rui-Sheng, Zhu, Ji-Hai, Wu, Jian-Ying, Song, Bing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8284753/
https://www.ncbi.nlm.nih.gov/pubmed/34260533
http://dx.doi.org/10.1097/MD.0000000000026556
_version_ 1783723451656175616
author Zhao, Peng-Ying
Wang, Yong-Hong
Liu, Rui-Sheng
Zhu, Ji-Hai
Wu, Jian-Ying
Song, Bing
author_facet Zhao, Peng-Ying
Wang, Yong-Hong
Liu, Rui-Sheng
Zhu, Ji-Hai
Wu, Jian-Ying
Song, Bing
author_sort Zhao, Peng-Ying
collection PubMed
description BACKGROUND: Currently, transcatheter aortic valve implantation (TAVI) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, the efficacy and safety of TAVI have not yet been well evaluated and its noninferiority compared with traditional surgical aortic valve replacement (sAVR) still lack sufficient evidence. This meta-analysis was designed to comprehensively compare the noninferiority of TAVI with sAVR for patients with severe aortic disease. METHODS: A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVI and sAVR in the treatment of severe aortic disease. The primary outcomes were early, midterm and long term mortality. The secondary outcomes included early complications and other late outcomes. Two reviewers assessed trial quality and extracted the data independently. All statistical analyzes were performed using the standard statistical procedures provided in Review Manager 5.2. RESULTS: A total of 16 studies including 14394 patients were identified. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVI and sAVR. Regarding to the 30-day outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of myocardial infarction (risk ratio [RR] 0.62; 95% confidence interval [CI] 0.40–0.97; 5441 pts), cardiogenic shock (RR 0.34; 95% CI 0.19–0.59; 1936 pts), acute kidney injury (AKI) > stage 2 (RR 0.37; 95% CI 0.25–0.54; 5371 pts), and new-onset atrial fibrillation (NOAF) (RR 0.29; 95% CI 0.24–0.35; 5371 pts) respectively, but higher incidence of permanent pacemaker implantation (RR 3.16; 95% CI 1.61–6.21; 5441 pts) and major vascular complications (RR 2.22; 95% CI 1.14–4.32; 5371 pts). Regarding to the 1- and 2-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of neurological events, transient ischemic attacks (TIA), permanent pacemaker and major vascular complications respectively. Regarding to the 5-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of TIA and reintervention respectively. CONCLUSIONS: Our analysis shows that TAVI was equal to sAVR in early, midterm and long term mortality for patients with severe aortic disease. In addition, TAVI may be favorable in reducing the incidence of both early, midterm and long term NOAF. However, pooled results showed superiority of sAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications and reintervention.
format Online
Article
Text
id pubmed-8284753
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Lippincott Williams & Wilkins
record_format MEDLINE/PubMed
spelling pubmed-82847532021-07-19 The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials Zhao, Peng-Ying Wang, Yong-Hong Liu, Rui-Sheng Zhu, Ji-Hai Wu, Jian-Ying Song, Bing Medicine (Baltimore) 3400 BACKGROUND: Currently, transcatheter aortic valve implantation (TAVI) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, the efficacy and safety of TAVI have not yet been well evaluated and its noninferiority compared with traditional surgical aortic valve replacement (sAVR) still lack sufficient evidence. This meta-analysis was designed to comprehensively compare the noninferiority of TAVI with sAVR for patients with severe aortic disease. METHODS: A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVI and sAVR in the treatment of severe aortic disease. The primary outcomes were early, midterm and long term mortality. The secondary outcomes included early complications and other late outcomes. Two reviewers assessed trial quality and extracted the data independently. All statistical analyzes were performed using the standard statistical procedures provided in Review Manager 5.2. RESULTS: A total of 16 studies including 14394 patients were identified. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVI and sAVR. Regarding to the 30-day outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of myocardial infarction (risk ratio [RR] 0.62; 95% confidence interval [CI] 0.40–0.97; 5441 pts), cardiogenic shock (RR 0.34; 95% CI 0.19–0.59; 1936 pts), acute kidney injury (AKI) > stage 2 (RR 0.37; 95% CI 0.25–0.54; 5371 pts), and new-onset atrial fibrillation (NOAF) (RR 0.29; 95% CI 0.24–0.35; 5371 pts) respectively, but higher incidence of permanent pacemaker implantation (RR 3.16; 95% CI 1.61–6.21; 5441 pts) and major vascular complications (RR 2.22; 95% CI 1.14–4.32; 5371 pts). Regarding to the 1- and 2-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of neurological events, transient ischemic attacks (TIA), permanent pacemaker and major vascular complications respectively. Regarding to the 5-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of TIA and reintervention respectively. CONCLUSIONS: Our analysis shows that TAVI was equal to sAVR in early, midterm and long term mortality for patients with severe aortic disease. In addition, TAVI may be favorable in reducing the incidence of both early, midterm and long term NOAF. However, pooled results showed superiority of sAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications and reintervention. Lippincott Williams & Wilkins 2021-07-16 /pmc/articles/PMC8284753/ /pubmed/34260533 http://dx.doi.org/10.1097/MD.0000000000026556 Text en Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/)
spellingShingle 3400
Zhao, Peng-Ying
Wang, Yong-Hong
Liu, Rui-Sheng
Zhu, Ji-Hai
Wu, Jian-Ying
Song, Bing
The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials
title The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials
title_full The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials
title_fullStr The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials
title_full_unstemmed The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials
title_short The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials
title_sort noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: evidence based on 16 randomized controlled trials
topic 3400
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8284753/
https://www.ncbi.nlm.nih.gov/pubmed/34260533
http://dx.doi.org/10.1097/MD.0000000000026556
work_keys_str_mv AT zhaopengying thenoninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT wangyonghong thenoninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT liuruisheng thenoninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT zhujihai thenoninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT wujianying thenoninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT songbing thenoninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT zhaopengying noninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT wangyonghong noninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT liuruisheng noninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT zhujihai noninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT wujianying noninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials
AT songbing noninferiorityoftranscatheteraorticvalveimplantationcomparedtosurgicalaorticvalvereplacementforsevereaorticdiseaseevidencebasedon16randomizedcontrolledtrials