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December 15, 2015; 85 (24) Article

IV thrombolysis in very severe and severe ischemic stroke

Results from the SITS-ISTR Registry

Michael V. Mazya, Kennedy R. Lees, David Collas, Viiu-Marika Rand, Robert Mikulik, Danilo Toni, Nils Wahlgren, Niaz Ahmed
First published November 6, 2015, DOI: https://doi.org/10.1212/WNL.0000000000002199
Michael V. Mazya
From the Department of Neurology (M.V.M., N.W., N.A.), Karolinska University Hospital, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Acute Stroke Unit & Cerebrovascular Clinic (K.R.L.), Institute of Cardiovascular & Medical Sciences, University of Glasgow; Stroke Unit (D.C.), Watford General Hospital, UK; Department of Neurology (V.-M.R.), North Estonia Medical Centre, Tallinn, Estonia; International Clinical Research Center and Department of Neurology (R.M.), St. Anne's University Hospital, Brno, Czech Republic; and Department of Neurology and Psychiatry (D.T.), Sapienza University of Rome, Italy.
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Kennedy R. Lees
From the Department of Neurology (M.V.M., N.W., N.A.), Karolinska University Hospital, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Acute Stroke Unit & Cerebrovascular Clinic (K.R.L.), Institute of Cardiovascular & Medical Sciences, University of Glasgow; Stroke Unit (D.C.), Watford General Hospital, UK; Department of Neurology (V.-M.R.), North Estonia Medical Centre, Tallinn, Estonia; International Clinical Research Center and Department of Neurology (R.M.), St. Anne's University Hospital, Brno, Czech Republic; and Department of Neurology and Psychiatry (D.T.), Sapienza University of Rome, Italy.
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David Collas
From the Department of Neurology (M.V.M., N.W., N.A.), Karolinska University Hospital, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Acute Stroke Unit & Cerebrovascular Clinic (K.R.L.), Institute of Cardiovascular & Medical Sciences, University of Glasgow; Stroke Unit (D.C.), Watford General Hospital, UK; Department of Neurology (V.-M.R.), North Estonia Medical Centre, Tallinn, Estonia; International Clinical Research Center and Department of Neurology (R.M.), St. Anne's University Hospital, Brno, Czech Republic; and Department of Neurology and Psychiatry (D.T.), Sapienza University of Rome, Italy.
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Viiu-Marika Rand
From the Department of Neurology (M.V.M., N.W., N.A.), Karolinska University Hospital, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Acute Stroke Unit & Cerebrovascular Clinic (K.R.L.), Institute of Cardiovascular & Medical Sciences, University of Glasgow; Stroke Unit (D.C.), Watford General Hospital, UK; Department of Neurology (V.-M.R.), North Estonia Medical Centre, Tallinn, Estonia; International Clinical Research Center and Department of Neurology (R.M.), St. Anne's University Hospital, Brno, Czech Republic; and Department of Neurology and Psychiatry (D.T.), Sapienza University of Rome, Italy.
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Robert Mikulik
From the Department of Neurology (M.V.M., N.W., N.A.), Karolinska University Hospital, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Acute Stroke Unit & Cerebrovascular Clinic (K.R.L.), Institute of Cardiovascular & Medical Sciences, University of Glasgow; Stroke Unit (D.C.), Watford General Hospital, UK; Department of Neurology (V.-M.R.), North Estonia Medical Centre, Tallinn, Estonia; International Clinical Research Center and Department of Neurology (R.M.), St. Anne's University Hospital, Brno, Czech Republic; and Department of Neurology and Psychiatry (D.T.), Sapienza University of Rome, Italy.
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Danilo Toni
From the Department of Neurology (M.V.M., N.W., N.A.), Karolinska University Hospital, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Acute Stroke Unit & Cerebrovascular Clinic (K.R.L.), Institute of Cardiovascular & Medical Sciences, University of Glasgow; Stroke Unit (D.C.), Watford General Hospital, UK; Department of Neurology (V.-M.R.), North Estonia Medical Centre, Tallinn, Estonia; International Clinical Research Center and Department of Neurology (R.M.), St. Anne's University Hospital, Brno, Czech Republic; and Department of Neurology and Psychiatry (D.T.), Sapienza University of Rome, Italy.
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Nils Wahlgren
From the Department of Neurology (M.V.M., N.W., N.A.), Karolinska University Hospital, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Acute Stroke Unit & Cerebrovascular Clinic (K.R.L.), Institute of Cardiovascular & Medical Sciences, University of Glasgow; Stroke Unit (D.C.), Watford General Hospital, UK; Department of Neurology (V.-M.R.), North Estonia Medical Centre, Tallinn, Estonia; International Clinical Research Center and Department of Neurology (R.M.), St. Anne's University Hospital, Brno, Czech Republic; and Department of Neurology and Psychiatry (D.T.), Sapienza University of Rome, Italy.
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Niaz Ahmed
From the Department of Neurology (M.V.M., N.W., N.A.), Karolinska University Hospital, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Acute Stroke Unit & Cerebrovascular Clinic (K.R.L.), Institute of Cardiovascular & Medical Sciences, University of Glasgow; Stroke Unit (D.C.), Watford General Hospital, UK; Department of Neurology (V.-M.R.), North Estonia Medical Centre, Tallinn, Estonia; International Clinical Research Center and Department of Neurology (R.M.), St. Anne's University Hospital, Brno, Czech Republic; and Department of Neurology and Psychiatry (D.T.), Sapienza University of Rome, Italy.
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Citation
IV thrombolysis in very severe and severe ischemic stroke
Results from the SITS-ISTR Registry
Michael V. Mazya, Kennedy R. Lees, David Collas, Viiu-Marika Rand, Robert Mikulik, Danilo Toni, Nils Wahlgren, Niaz Ahmed
Neurology Dec 2015, 85 (24) 2098-2106; DOI: 10.1212/WNL.0000000000002199

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Abstract

Objective: To study the safety of off-label IV thrombolysis in patients with very severe stroke (NIH Stroke Scale [NIHSS] scores >25) compared with severe stroke (NIHSS scores 15–25), where treatment is within European regulations.

Methods: Data were analyzed from 57,247 patients with acute ischemic stroke receiving IV tissue plasminogen activator in 793 hospitals participating in the Safe Implementation of Thrombolysis in Stroke (SITS) International Stroke Thrombolysis Registry (2002–2013). Eight hundred sixty-eight patients (1.5%) had NIHSS scores >25 and 19,995 (34.9%) had NIHSS scores 15–25. Outcome measures were parenchymal hemorrhage, symptomatic intracerebral hemorrhage, mortality, and functional outcome.

Results: Parenchymal hemorrhage occurred in 10.7% vs 11.0% (p = 0.79), symptomatic intracerebral hemorrhage per SITS-MOST (SITS–Monitoring Study) in 1.4% vs 2.5% (p = 0.052), death at 3 months in 50.4% vs 26.9% (p < 0.001), and functional independence at 3 months in 14.0% vs 29.0% (p < 0.001) of patients with NIHSS scores >25 and NIHSS scores 15–25, respectively. Multivariate adjustment did not change findings from univariate comparisons. Posterior circulation stroke was more common in patients with NIHSS scores >25 (36.2% vs 7.4%, p < 0.001), who were also more often obtunded or comatose on presentation (58.4% vs 7.1%, p < 0.001). Of patients with NIHSS scores >25, 26.2% were treated >3 hours from symptom onset vs 14.5% with NIHSS scores of 15–25.

Conclusions: Our data show no excess risk of cerebral hemorrhage in patients with NIHSS score >25 compared to score 15–25, suggesting that the European contraindication to IV tissue plasminogen activator treatment at NIHSS levels >25 may be unwarranted. Increased mortality and lower rates of functional independence in patients with NIHSS score >25 are explained by higher stroke severity, impaired consciousness on presentation due to posterior circulation ischemia, and longer treatment delays.

GLOSSARY

aOR=
adjusted odds ratio;
ECASS II=
European Cooperative Acute Stroke Study II;
ICH=
intracerebral hemorrhage;
IST-3=
Third International Stroke Trial;
mRS=
modified Rankin Scale;
NIHSS=
NIH Stroke Scale;
NINDS=
National Institute of Neurological Diseases and Stroke;
PH=
parenchymal hemorrhage;
SICH=
symptomatic intracerebral hemorrhage;
SITS-ISTR=
Safe Implementation of Thrombolysis in Stroke–International Stroke Thrombolysis Register;
SITS-MOST=
Safe Implementation of Thrombolysis in Stroke–Monitoring Study;
tPA=
tissue plasminogen activator;
VISTA=
Virtual International Stroke Trials Archive

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Supplemental data at Neurology.org

  • Editorial, page 2088

  • Received March 10, 2015.
  • Accepted in final form August 3, 2015.
  • © 2015 American Academy of Neurology
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Letters: Rapid online correspondence

  • Response to comment by Dr. S. Sharma
    • Michael V. Mazya, MD, PhD, Dept. of Clinical Neuroscience, Karolinska Institutet, Stockholm, Swedenmichael.mazya@karolinska.se
    • N. Wahlgren, N. Ahmed
    Submitted January 08, 2016
  • Contribution of selection bias to results in the study
    • Sameer Sharma, Stroke fellow, Suny upstate university hospitalSameersharma12@gmail.com
    Submitted December 30, 2015
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