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: 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.
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Authors | Michael V Mazya, Kennedy R Lees, David Collas, Viiu-Marika Rand, Robert Mikulik, Danilo Toni, Nils Wahlgren, Niaz Ahmed |
Journal | Neurology
(Neurology)
Vol. 85
Issue 24
Pg. 2098-106
(Dec 15 2015)
ISSN: 1526-632X [Electronic] United States |
PMID | 26546630
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 American Academy of Neurology. |
Chemical References |
- Tissue Plasminogen Activator
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Topics |
- Aged
- Aged, 80 and over
- Brain Ischemia
(diagnosis, drug therapy)
- Female
- Humans
- Infusions, Intravenous
- Internationality
- Male
- Middle Aged
- Registries
- Severity of Illness Index
- Stroke
(diagnosis, drug therapy)
- Thrombolytic Therapy
(methods)
- Tissue Plasminogen Activator
(administration & dosage)
- Treatment Outcome
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