Solitaire Thrombectomy for Acute Stroke Due to Intracranial Atherosclerosis-Related Occlusion: ROSE ASSIST Study

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Abstract

Background: Solitaire, a representative stent retriever, has shown high performance in removing embolic clots. However, its reperfusion potential in intracranial atherosclerotic stenosis (ICAS)-related occlusions has rarely been reported. In this ROSE ASSIST study, we hypothesized that Solitaire device is as effective and safe for removing in situ thrombi in ICAS-related occlusions as it is for removal of embolic occlusions.

Methods: Data from ASIAN KR, an observational multicenter registry ( n = 720) enrolling patients who have undergone endovascular treatment for acute cervicocephalic artery occlusions, were retrospectively reviewed. Through blinded evaluations, occlusions were classified as ICAS-related (significant fixed focal stenosis observed at the occlusion site during endovascular treatment) or embolic (no or minimal stenosis observed). Among patients treated within 720 min after stroke onset, those who undertook Solitaire thrombectomy and whose underlying etiology was ICAS-related or embolic were included. The primary endpoint was immediate successful reperfusion (modified Treatment In Cerebral Ischemia 2b−3) after Solitaire stent retrieval. The safety endpoint included intracerebral hemorrhagic transformation and subarachnoid hemorrhage. Comparative analyses were performed between embolic and ICAS-related occlusions with 2:1 propensity score matching.

Results: In total, 303 patients (embolic, 228; ICAS-related, 75) were included in the analyses. As for the primary endpoint, the immediate successful reperfusion rate following Solitaire thrombectomy did not differ between the two etiologic groups after propensity score matching (73.1% embolic vs. 65.8% ICAS-related, p = 0.261). The final successful reperfusion grade was also similar in the two groups (79.3 vs. 72.0%, p = 0.219). The grades and frequencies of intracerebral hemorrhagic transformation and subarachnoid hemorrhage did not differ between groups ( p = 0.134 and p = 0.269, respectively).

Conclusions: The immediate reperfusion performance in terms of thrombus removal of Solitaire thrombectomy for ICAS-related occlusions was similar to that for embolic occlusions.

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Most cited references 26

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Stenting versus aggressive medical therapy for intracranial arterial stenosis.

Marc I Chimowitz, Michael J Lynn, Colin Derdeyn … (2011)

Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of follow-up, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.).

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A critical appraisal of propensity-score matching in the medical literature between 1996 and 2003.

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Propensity-score methods are increasingly being used to reduce the impact of treatment-selection bias in the estimation of treatment effects using observational data. Commonly used propensity-score methods include covariate adjustment using the propensity score, stratification on the propensity score, and propensity-score matching. Empirical and theoretical research has demonstrated that matching on the propensity score eliminates a greater proportion of baseline differences between treated and untreated subjects than does stratification on the propensity score. However, the analysis of propensity-score-matched samples requires statistical methods appropriate for matched-pairs data. We critically evaluated 47 articles that were published between 1996 and 2003 in the medical literature and that employed propensity-score matching. We found that only two of the articles reported the balance of baseline characteristics between treated and untreated subjects in the matched sample and used correct statistical methods to assess the degree of imbalance. Thirteen (28 per cent) of the articles explicitly used statistical methods appropriate for the analysis of matched data when estimating the treatment effect and its statistical significance. Common errors included using the log-rank test to compare Kaplan-Meier survival curves in the matched sample, using Cox regression, logistic regression, chi-squared tests, t-tests, and Wilcoxon rank sum tests in the matched sample, thereby failing to account for the matched nature of the data. We provide guidelines for the analysis and reporting of studies that employ propensity-score matching. Copyright (c) 2007 John Wiley & Sons, Ltd.

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Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial.

Osama Zaidat, Brian-Fred Fitzsimmons, Britton Woodward … (2015)

Intracranial stenosis is one of the most common etiologies of stroke. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis.

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Author and article information

Contributors

Jin Soo Lee: URI : http://loop.frontiersin.org/people/594971/overview

Ji Man Hong: URI : http://loop.frontiersin.org/people/595710/overview

Chang-Hyun Kim: URI : http://loop.frontiersin.org/people/596975/overview

Yong-Won Kim: URI : http://loop.frontiersin.org/people/603120/overview

Dong-Hun Kang: URI : http://loop.frontiersin.org/people/630434/overview

Yang-Ha Hwang: URI : http://loop.frontiersin.org/people/187830/overview

Sung-Il Sohn: URI : http://loop.frontiersin.org/people/597048/overview

Journal

Journal ID (nlm-ta): Front Neurol

Journal ID (iso-abbrev): Front Neurol

Journal ID (publisher-id): Front. Neurol.

Title: Frontiers in Neurology

Publisher: Frontiers Media S.A.

ISSN (Electronic): 1664-2295

Publication date (Electronic): 11 December 2018

Publication date Collection: 2018

Volume: 9

Electronic Location Identifier: 1064

Affiliations

[1] ¹Department of Neurology, Ajou University School of Medicine, Ajou University Medical Center , Suwon, South Korea

[2] ²Department of Radiology, Ajou University School of Medicine, Ajou University Medical Center , Suwon, South Korea

[3] ³Department of Neurology, Keimyung University Dongsan Medical Center , Daegu, South Korea

[4] ⁴Department of Neurosurgery, Keimyung University Dongsan Medical Center , Daegu, South Korea

[5] ⁵Department of Neurology, Kyungpook National University School of Medicine , Daegu, South Korea

[6] ⁶Department of Radiology, Kyungpook National University School of Medicine , Daegu, South Korea

[7] ⁷Department of Neurosurgery, Kyungpook National University School of Medicine , Daegu, South Korea

Author notes

Edited by: Byung Moon Kim, Severance Hospital, South Korea

Reviewed by: Oh Young Bang, Sungkyunkwan University School of Medicine, South Korea; Cheolkyu Jung, Seoul National University Bundang Hospital, South Korea; Young Dae Kim, Yonsei University College of Medicine, South Korea

*Correspondence: Jin Soo Lee jinsoo22@ 123456gmail.com

This article was submitted to Endovascular and Interventional Neurology, a section of the journal Frontiers in Neurology

Article

DOI: 10.3389/fneur.2018.01064

PMC ID: 6297378

PubMed ID: 30619033

SO-VID: 9674c837-dbc5-4823-9728-b79a3b00c27d

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This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

History

Date received : 31 July 2018

Date accepted : 22 November 2018

Page count

Figures: 4, Tables: 3, Equations: 0, References: 39, Pages: 9, Words: 6271

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Solitaire Thrombectomy for Acute Stroke Due to Intracranial Atherosclerosis-Related Occlusion: ROSE ASSIST Study

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Most cited references 26

Stenting versus aggressive medical therapy for intracranial arterial stenosis.

A critical appraisal of propensity-score matching in the medical literature between 1996 and 2003.

Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial.

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Cited by 11

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