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Trevo 2000: Results of a Large Real‐World Registry for Stent Retriever for Acute Ischemic Stroke
BACKGROUND: Recent randomized controlled trials show benefit of thrombectomy for large vessel occlusion in stroke. Real‐world data aid in assessing reproducibility of outcomes outside of clinical trials. The Trevo Retriever Registry is a multicenter, international, prospective study designed to asse...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6405611/ https://www.ncbi.nlm.nih.gov/pubmed/30561262 http://dx.doi.org/10.1161/JAHA.118.010867 |
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author | Binning, Mandy J. Bartolini, Bruno Baxter, Blaise Budzik, Ronald English, Joey Gupta, Rishi Hedayat, Hirad Krajina, Antonin Liebeskind, David Nogueira, Raul G. Shields, Ryan Veznedaroglu, Erol |
author_facet | Binning, Mandy J. Bartolini, Bruno Baxter, Blaise Budzik, Ronald English, Joey Gupta, Rishi Hedayat, Hirad Krajina, Antonin Liebeskind, David Nogueira, Raul G. Shields, Ryan Veznedaroglu, Erol |
author_sort | Binning, Mandy J. |
collection | PubMed |
description | BACKGROUND: Recent randomized controlled trials show benefit of thrombectomy for large vessel occlusion in stroke. Real‐world data aid in assessing reproducibility of outcomes outside of clinical trials. The Trevo Retriever Registry is a multicenter, international, prospective study designed to assess outcomes in a large cohort of patients. METHODS AND RESULTS: The Trevo Registry is a prospective database of patients with large vessel occlusion treated with the Trevo device as the first device. The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score and secondary end points include 90‐day modified Rankin Scale, 90‐day mortality, neurological deterioration at 24 hours, and device/procedure related adverse events. Year 2008 patients were enrolled at 76 centers in 12 countries. Median admission National Institutes of Health Stroke Scale was 16 (interquartile range, 11–20). Occlusion sites were internal carotid artery (17.8%), middle cerebral artery (73.5%), posterior circulation (7.1%), and distal vascular locations (1.6%). A modified Thrombolysis in Cerebral Infarction 2b or 3 was achieved in 92.8% (95% CI, 91.6, 93.9) of procedures, with 55.3% (95% CI, 53.1, 57.5) of patients achieving modified Rankin Scale ≤2 at 3 months. Patients meeting revised 2015 American Heart Association criteria for thrombectomy had a 59.7% (95% CI, 56.0; 63.4) modified Rankin Scale 0 to 2 at 3 months, whereas 51.4% treated outside of American Heart Association criteria had modified Rankin Scale 0 to 2. 51.4% (95% CI, 49.6, 55.4). Symptomatic intracranial hemorrhage rate was 1.7% (95% CI, 1.2, 2.4). CONCLUSIONS: The Trevo Retriever Registry represents real‐world data with stent retriever. The registry demonstrates similar reperfusion rates and outcomes in the community compared with rigorous centrally adjudicated clinical trials. Future subgroup analysis of this cohort will assist in identifying areas of future research. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02040259. |
format | Online Article Text |
id | pubmed-6405611 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-64056112019-03-19 Trevo 2000: Results of a Large Real‐World Registry for Stent Retriever for Acute Ischemic Stroke Binning, Mandy J. Bartolini, Bruno Baxter, Blaise Budzik, Ronald English, Joey Gupta, Rishi Hedayat, Hirad Krajina, Antonin Liebeskind, David Nogueira, Raul G. Shields, Ryan Veznedaroglu, Erol J Am Heart Assoc Original Research BACKGROUND: Recent randomized controlled trials show benefit of thrombectomy for large vessel occlusion in stroke. Real‐world data aid in assessing reproducibility of outcomes outside of clinical trials. The Trevo Retriever Registry is a multicenter, international, prospective study designed to assess outcomes in a large cohort of patients. METHODS AND RESULTS: The Trevo Registry is a prospective database of patients with large vessel occlusion treated with the Trevo device as the first device. The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score and secondary end points include 90‐day modified Rankin Scale, 90‐day mortality, neurological deterioration at 24 hours, and device/procedure related adverse events. Year 2008 patients were enrolled at 76 centers in 12 countries. Median admission National Institutes of Health Stroke Scale was 16 (interquartile range, 11–20). Occlusion sites were internal carotid artery (17.8%), middle cerebral artery (73.5%), posterior circulation (7.1%), and distal vascular locations (1.6%). A modified Thrombolysis in Cerebral Infarction 2b or 3 was achieved in 92.8% (95% CI, 91.6, 93.9) of procedures, with 55.3% (95% CI, 53.1, 57.5) of patients achieving modified Rankin Scale ≤2 at 3 months. Patients meeting revised 2015 American Heart Association criteria for thrombectomy had a 59.7% (95% CI, 56.0; 63.4) modified Rankin Scale 0 to 2 at 3 months, whereas 51.4% treated outside of American Heart Association criteria had modified Rankin Scale 0 to 2. 51.4% (95% CI, 49.6, 55.4). Symptomatic intracranial hemorrhage rate was 1.7% (95% CI, 1.2, 2.4). CONCLUSIONS: The Trevo Retriever Registry represents real‐world data with stent retriever. The registry demonstrates similar reperfusion rates and outcomes in the community compared with rigorous centrally adjudicated clinical trials. Future subgroup analysis of this cohort will assist in identifying areas of future research. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02040259. John Wiley and Sons Inc. 2018-12-10 /pmc/articles/PMC6405611/ /pubmed/30561262 http://dx.doi.org/10.1161/JAHA.118.010867 Text en © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Research Binning, Mandy J. Bartolini, Bruno Baxter, Blaise Budzik, Ronald English, Joey Gupta, Rishi Hedayat, Hirad Krajina, Antonin Liebeskind, David Nogueira, Raul G. Shields, Ryan Veznedaroglu, Erol Trevo 2000: Results of a Large Real‐World Registry for Stent Retriever for Acute Ischemic Stroke |
title | Trevo 2000: Results of a Large Real‐World Registry for Stent Retriever for Acute Ischemic Stroke |
title_full | Trevo 2000: Results of a Large Real‐World Registry for Stent Retriever for Acute Ischemic Stroke |
title_fullStr | Trevo 2000: Results of a Large Real‐World Registry for Stent Retriever for Acute Ischemic Stroke |
title_full_unstemmed | Trevo 2000: Results of a Large Real‐World Registry for Stent Retriever for Acute Ischemic Stroke |
title_short | Trevo 2000: Results of a Large Real‐World Registry for Stent Retriever for Acute Ischemic Stroke |
title_sort | trevo 2000: results of a large real‐world registry for stent retriever for acute ischemic stroke |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6405611/ https://www.ncbi.nlm.nih.gov/pubmed/30561262 http://dx.doi.org/10.1161/JAHA.118.010867 |
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