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Cited by 670Acute Ischemic Stroke ManagementAcute Myocardial Infarction ResearchIntracerebral and Subarachnoid Hemorrhage Research

Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association

Demaerschalk, Bart M., Kleindorfer, Dawn O., Adeoye, Opeolu M., Demchuk, Andrew M., Fugate, Jennifer E., Grotta, James C., Khalessi, Alexander A., Levy, Elad I. +5 more·2016·Stroke
DOI 10.1161/str.0000000000000086
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Abstract

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 Council Leadership review, and Scientific Statements Oversight Committee review before consideration and approval by the American Heart Association Science Advisory and Coordinating Committee. RESULTS: After a review of the current literature, it was clearly evident that the levels of evidence supporting individual exclusion criteria for intravenous alteplase vary widely. Several exclusionary criteria have already undergone extensive scientific study such as the clear benefit of alteplase treatment in elderly stroke patients, those with severe stroke, those with diabetes mellitus and hyperglycemia, and those with minor early ischemic changes evident on computed tomography. Some exclusions such as recent intracranial surgery are likely based on common sense and sound judgment and are unlikely to ever be subjected to a randomized, clinical trial to evaluate safety. Most other contraindications or warnings range somewhere in between. However, the differential impact of each exclusion criterion varies not only with the evidence base behind it but also with the frequency of the exclusion within the stroke population, the probability of coexistence of multiple exclusion factors in a single patient, and the variation in practice among treating clinicians.

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Authors
Demaerschalk, B. M., Kleindorfer, D. O., Adeoye, O. M., Demchuk, A. M., Fugate, J. E., Grotta, J. C., Khalessi, A. A., Levy, E. I., Palesch, Y. Y., Prabhakaran, S., Saposnik, G., Saver, J. L., & Smith, E. E.
ORCID
Venue
Stroke
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2016-02
Volume
47
Issue
2
Pages
581-641
ISSN
  • 0039-2499 (ISSN-L)
  • 1524-4628
DOI
10.1161/str.0000000000000086
OpenAlex
W2203834727
Cited by
670
References
465
Citations by year
2026: 35 · 2025: 39 · 2024: 58 · 2023: 47 · 2022: 60 · 2021: 64 · 2020: 61 · 2019: 72 · 2018: 99 · 2017: 106 · 2016: 26 · 2014: 2
FWCI
60.37
Type
journal article
Language
en
Update notices
correction (2016-11-01)
Open access
closed
Locations
  • Stroke (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
  • Health Sciences › Medicine › Neurology › Intracerebral and Subarachnoid Hemorrhage Research
Keywords
alteplase, intravenous thrombolysis, acute ischemic stroke, inclusion criteria, exclusion criteria, contraindications, tissue plasminogen activator, elderly stroke patients, severe stroke, diabetes mellitus, hyperglycemia, treatment safety
MeSH terms
Adult, Age Factors, Aged, Aged, 80 and over, American Heart Association, Brain Ischemia, Fibrinolytic Agents, Hemorrhage, Humans, Middle Aged, Tissue Plasminogen Activator, Societies, Medical, United States, Practice Guidelines as Topic, Risk Assessment, Patient Selection, Evidence-Based Medicine, Stroke, Administration, Intravenous

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