No Increased Risk of Symptomatic Intracerebral Hemorrhage After Thrombolysis in Patients With European Cooperative Acute Stroke Study (ECASS) Exclusion Criteria

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237

Purpose-To critically review and evaluate the science behind individual eligibility criteria (indication/inclusion and contraindications/exclusion criteria) for intravenous recombinant tissue-type plasminogen activator (alteplase) treatment in acute ischemic stroke. This will allow us to better inform stroke providers of quantitative and qualitative risks associated with alteplase administration under selected commonly and uncommonly encountered clinical circumstances and to identify future research priorities concerning these eligibility criteria, which could potentially expand the safe and judicious use of alteplase and improve outcomes after stroke. Methods-Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association Stroke Council's Scientific Statement Oversight Committee and the American Heart Association's Manuscript Oversight Committee. The writers used systematic literature reviews, references to published clinical and epidemiology studies, morbidity and mortality reports, clinical and public health guidelines, authoritative statements, personal files, and expert opinion to summarize existing evidence and to indicate gaps in current knowledge and, when appropriate, formulated recommendations using standard American Heart Association criteria. All members of the writing group had the opportunity to comment on and approved the final version of this document. The document underwent extensive American Heart Association internal peer review, Stroke The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest.This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on September 24, 2015, and the American Heart Association Executive Committee on October 5, 2015. A copy of the document is available at http://my.americanheart.org/statements by selecting either the "By Topic" link or the "By Publication Date" link. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@ wolterskluwer.com.The online-only Data Supplement, which contains literature search strategies and Figures A, B, and C, is available with this article at http://circ. ahajournals.org/lookup/suppl/doi:10.1161/STR.0000000000000086/-/DC1.The American Heart Association requests that this document be cited as follows: Demaerschalk BM, Kleindorfer DO, Adeoye OM, Demchuk AM, Fugate JE, Grotta JC, Khalessi AA, Levy EI, Palesch YY, Prabhakaran S, Saposnik G, Saver JL, Smith EE; on behalf of the American Heart Association Stroke Council and Council on Epidemiology and Prevention. Scientific rational...

Section: Warfarin Usementioning

confidence: 94%

Section: February 2016mentioning

confidence: 99%

Section: Stroke and Diabetes Mellitusmentioning

confidence: 99%

See 1 more Smart Citation

Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke

Demaerschalk¹,

Kleindorfer²,

Adeoye³

et al. 2016

585

237

“…[6][7][8][9][10][11][12][13][14][15] There are also now randomized trial data from the Third International Stroke Trial (IST-3), which enrolled patients for whom there was equipoise regarding the benefits of thrombolytic therapy and randomized to treatment with IV tPA versus placebo ≤6 hours from onset. 16 This study included 1617 patients aged >80 years and found that although the rate of good outcome in that group was overall lower than younger patients, there was still a significant benefit to treatment with IV tPA.…”

Section: September 2014mentioning

confidence: 99%

Adherence to Third European Cooperative Acute Stroke Study 3- to 4.5-Hour Exclusions and Association With Outcome

Cronin

Sheth

Zhao

et al. 2014

Self Cite

Background and Purpose— The American Heart Association/American Stroke Association guidelines recommend intravenous tissue-type plasminogen activator (tPA) treatment 3 to 4.5 hours from symptom onset according to criteria used in the Third European Cooperative Acute Stroke Study (ECASS III). However, ECASS III excluded certain patient groups in addition to the standard exclusions used for 0 to 3 hours in the United States: age >80 years, history of stroke and diabetes mellitus, oral anticoagulant treatment, and National Institutes of Health Stroke Scale >25. We investigated adherence to these additional exclusion criteria for patients treated 3 to 4.5 hours from onset and their association with outcome. Methods— We analyzed data from Get With The Guidelines-Stroke on 32 019 patients with ischemic stroke from 1464 hospitals who were treated with tPA ≤4.5 hours from onset from January 2009 to January 2012, excluding patients transferred from another hospital. The percent of patients meeting versus not meeting each exclusion criterion were compared between treatment time windows. Results— Overall, 1544 of 4910 (31.5%) patients treated with tPA >3 to 4.5 hours had at least 1 of the additional exclusions, the most common was age >80 years. With the exception of prior stroke and diabetes mellitus, the percent of tPA–treated patients with each exclusion criterion was significantly lower at >3 to 4.5 hours compared with 0 to 3 hours. For each additional exclusion criterion, there was no increased risk of symptomatic intracranial hemorrhage or worse hospital outcome for patients treated >3 to 4.5 hours compared with 0 to 3 hours, after adjusting for baseline differences. Conclusions— Patients with ECASS III–specific exclusion criteria for the >3 to 4.5 hours window are frequently treated with tPA. The presence of the additional exclusion criteria was not associated with worse outcomes in the >3 to 4.5 hours window compared with the 0 to 3 hours window.

“…However, the presence of single exclusion criterion, such as age >80 years, baseline NIHSS scores >25, or combination of prior stroke and diabetes mellitus, is not necessarily associated with an increased risk of SICH. 15 Hopefully, applying risk score models to identify low-risk patients might increase the number of patients with stroke who could benefit from intravenous thrombolytic therapy.…”

Section: June 2013mentioning

confidence: 99%

Comparison of Risk-scoring Systems in Predicting Symptomatic Intracerebral Hemorrhage After Intravenous Thrombolysis

Sung

Chen

Lin

et al. 2013

Background and Purpose— Various risk score models have been developed to predict symptomatic intracerebral hemorrhage (SICH) after intravenous thrombolysis for acute ischemic stroke. In this study, we aimed to determine the prediction performance of these risk scores in a Taiwanese population Methods— Prospectively collected data from 4 hospitals were used to calculate probability of SICH with the scores developed by Cucchiara et al, the Hemorrhage After Thrombolysis (HAT) score, the Safe Implementation of Thrombolysis in Stroke-SICH risk score, the Glucose Race Age Sex Pressure Stroke Severity score, and the Stroke Prognostication using Age and National Institutes of Health Stroke Scale-100 index. We used logistic regression to evaluate the effectiveness of each risk model in predicting SICH and the c statistic to assess performance. Results— A total of 548 patients were included. The rates of SICH were 7.3% by the National Institute of Neurological Diseases and Stroke definition, 5.3% by the European-Australasian Cooperative Acute Stroke Study II definition, and 3.5% by the Safe Implementation of Thrombolysis in Stroke-Monitoring Study definition. The Cucchiara score, the HAT score, and the Safe Implementation of Thrombolysis in Stroke-SICH risk score were significant predictors of SICH for all 3 definitions, whereas the Glucose Race Age Sex Pressure Stroke Severity score and the Stroke Prognostication using Age and National Institutes of Health Stroke Scale-100 index predicted well only for 1 or 2 definitions of SICH. The c statistic was highest for the HAT score (range, 0.69–0.73) across the definitions of SICH. Conclusions— The Cucchiara score, the HAT score, and the Safe Implementation of Thrombolysis in Stroke-SICH risk score predicted SICH reasonably well regardless of which SICH definition was used. However, only the HAT score had an acceptable discriminatory ability.