Evidence map›Paper›PMID 26546630›Full record

ArticleNeurology2015

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

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In one paragraph

Article in Neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 55 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Michael V MazyaFrom 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. michael.mazya@karolinska.se.
Kennedy R LeesFrom 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.
David CollasFrom 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.
Viiu-Marika RandFrom 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.
Robert MikulikFrom 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.
Danilo ToniFrom 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.
Nils WahlgrenFrom 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.
Niaz AhmedFrom 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.
University of Glasgow · GBWatford General Hospital · GBNorth Estonia Medical Centre · EESt. Anne's University Hospital Brno · CZUniversity Hospital Brno · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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.

methodsData 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.

resultsParenchymal 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.

conclusionsOur 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.

Indexed as

RegistriesSeverity of Illness IndexAgedAged, 80 and overBrain IschemiaFemaleHumansInfusions, IntravenousInternationalityMaleMiddle AgedStrokeThrombolytic TherapyTissue Plasminogen ActivatorTreatment OutcomeTissue Plasminogen Activator

Identifiers

PMID26546630
PMCPMC4691682
OpenAlexW2198715680

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.