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Effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (DEVT): 18-month follow-up of a randomized controlled trial

BACKGROUND: Two trials in Chinese population showed that endovascular treatment (EVT) alone was noninferior to alteplase follow by EVT at 90 days. However, results of long-term clinical outcomes remain unknown. We reported the results of prespecified 18-month analysis of the DEVT trail. MATERIALS AN...

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Autores principales: Ruan, Zhongfan, Luo, Xiaojun, Liu, Yongkang, Li, Fengli, Liu, Jincheng, Zi, Wenjie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9969708/
https://www.ncbi.nlm.nih.gov/pubmed/36849903
http://dx.doi.org/10.1186/s12883-023-03111-y
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author Ruan, Zhongfan
Luo, Xiaojun
Liu, Yongkang
Li, Fengli
Liu, Jincheng
Zi, Wenjie
author_facet Ruan, Zhongfan
Luo, Xiaojun
Liu, Yongkang
Li, Fengli
Liu, Jincheng
Zi, Wenjie
author_sort Ruan, Zhongfan
collection PubMed
description BACKGROUND: Two trials in Chinese population showed that endovascular treatment (EVT) alone was noninferior to alteplase follow by EVT at 90 days. However, results of long-term clinical outcomes remain unknown. We reported the results of prespecified 18-month analysis of the DEVT trail. MATERIALS AND METHODS: We assessed clinical outcomes 18 months after patients were randomly assigned to receive EVT alone or bridging therapy for acute ischemic stroke (AIS). The primary outcome was the proportion of functional independence [modified Rankin scale (mRS), 0–2] at 18 months. Secondary outcomes included all-cause mortality and the quality of life at 18 months as measured by means of a health utility index according to the European Quality of Life 5-Dimension 5-level scale (EQ-5D-5L). Kaplan-Meier event curves were used to investigate the risk of mortality in participants with EVT alone or bridging therapy. RESULTS: Among 234 patients (EVT alone, n = 116; bridging therapy, n = 118) in the DEVT trial, only 231 (98.7%) patients were extended follow-up to 18 months. A total of 60 (51.7%) patients in the EVT alone achieved functional independence vs 56 (47.5%) patients in the bridging therapy (difference, 4.3%; 1-sided 97.5% CI, − 8.4% to ∞, P for noninferiority =0.014). No significant between-group difference was detected in EQ-5D-5L score (0.81 vs 0.73; difference, 0; 95% CI, 0 to 0.005). The cumulative mortality was 27.6% in the EVT alone and 28.8% in the bridging therapy. CONCLUSION: At 18 months follow-up, EVT alone was noninferior to bridging therapy regarding favorable functional outcome in patients with AIS. TRIAL REGISTRATION: Trial was registered on Chinese Clinical Trial Registry (ChiCTR-IOR-17013568) on 27/11/2017. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-023-03111-y.
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spelling pubmed-99697082023-02-28 Effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (DEVT): 18-month follow-up of a randomized controlled trial Ruan, Zhongfan Luo, Xiaojun Liu, Yongkang Li, Fengli Liu, Jincheng Zi, Wenjie BMC Neurol Research BACKGROUND: Two trials in Chinese population showed that endovascular treatment (EVT) alone was noninferior to alteplase follow by EVT at 90 days. However, results of long-term clinical outcomes remain unknown. We reported the results of prespecified 18-month analysis of the DEVT trail. MATERIALS AND METHODS: We assessed clinical outcomes 18 months after patients were randomly assigned to receive EVT alone or bridging therapy for acute ischemic stroke (AIS). The primary outcome was the proportion of functional independence [modified Rankin scale (mRS), 0–2] at 18 months. Secondary outcomes included all-cause mortality and the quality of life at 18 months as measured by means of a health utility index according to the European Quality of Life 5-Dimension 5-level scale (EQ-5D-5L). Kaplan-Meier event curves were used to investigate the risk of mortality in participants with EVT alone or bridging therapy. RESULTS: Among 234 patients (EVT alone, n = 116; bridging therapy, n = 118) in the DEVT trial, only 231 (98.7%) patients were extended follow-up to 18 months. A total of 60 (51.7%) patients in the EVT alone achieved functional independence vs 56 (47.5%) patients in the bridging therapy (difference, 4.3%; 1-sided 97.5% CI, − 8.4% to ∞, P for noninferiority =0.014). No significant between-group difference was detected in EQ-5D-5L score (0.81 vs 0.73; difference, 0; 95% CI, 0 to 0.005). The cumulative mortality was 27.6% in the EVT alone and 28.8% in the bridging therapy. CONCLUSION: At 18 months follow-up, EVT alone was noninferior to bridging therapy regarding favorable functional outcome in patients with AIS. TRIAL REGISTRATION: Trial was registered on Chinese Clinical Trial Registry (ChiCTR-IOR-17013568) on 27/11/2017. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-023-03111-y. BioMed Central 2023-02-27 /pmc/articles/PMC9969708/ /pubmed/36849903 http://dx.doi.org/10.1186/s12883-023-03111-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Ruan, Zhongfan
Luo, Xiaojun
Liu, Yongkang
Li, Fengli
Liu, Jincheng
Zi, Wenjie
Effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (DEVT): 18-month follow-up of a randomized controlled trial
title Effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (DEVT): 18-month follow-up of a randomized controlled trial
title_full Effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (DEVT): 18-month follow-up of a randomized controlled trial
title_fullStr Effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (DEVT): 18-month follow-up of a randomized controlled trial
title_full_unstemmed Effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (DEVT): 18-month follow-up of a randomized controlled trial
title_short Effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (DEVT): 18-month follow-up of a randomized controlled trial
title_sort effect of direct endovascular treatment versus standard bridging therapy in large artery anterior circulation stroke (devt): 18-month follow-up of a randomized controlled trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9969708/
https://www.ncbi.nlm.nih.gov/pubmed/36849903
http://dx.doi.org/10.1186/s12883-023-03111-y
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