BACKGROUND AND PURPOSE: The pivotal National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator trials excluded patients with ischemic stroke with specific minor presentations or rapidly improving symptoms. The recombinant tissue plasminogen activator product label notes that its use for minor neurological deficit or rapidly improving stroke symptoms has not been evaluated. As a result, patients with low National Institutes of Health Stroke Scale scores are not commonly treated in clinical practice. We sought to further characterize the patients with minor stroke who were included in the National Institute of Neurological Disorders and Stroke trials. METHODS: Minor strokes were defined as National Institutes of Health Stroke Scale score ≤ 5 at baseline for this retrospective analysis, because this subgroup is most commonly excluded from treatment in clinical practice and trials. Clinical stroke syndromes were defined based on prespecified National Institutes of Health Stroke Scale item score clusters. Clinical outcomes were reviewed generally and within these cluster subgroups. RESULTS: Only 58 cases had National Institutes of Health Stroke Scale scores of 0 to 5 in the National Institute of Neurological Disorders and Stroke trials (42 recombinant tissue plasminogen activator and 16 placebo), and 2971 patients were excluded from the trials due to "rapidly improving" or "minor symptoms" as the primary reason. No patients were enrolled with isolated motor symptoms, isolated facial droop, isolated ataxia, dysarthria, isolated sensory symptoms, or with only symptoms/signs not captured by the National Institutes of Health Stroke Scale score (ie, National Institutes of Health Stroke Scale=0). There were ≤ 3 patients with each of the other isolated deficits enrolled in the trial. CONCLUSIONS: The National Institute of Neurological Disorders and Stroke trials excluded a substantial number of strokes with minor presentations, those that were included were small in number, and conclusions about outcomes based on specific syndromes cannot be drawn. Further prospective, systematic study of this subgroup is needed.
BACKGROUND AND PURPOSE: The pivotal National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator trials excluded patients with ischemic stroke with specific minor presentations or rapidly improving symptoms. The recombinant tissue plasminogen activator product label notes that its use for minor neurological deficit or rapidly improving stroke symptoms has not been evaluated. As a result, patients with low National Institutes of Health Stroke Scale scores are not commonly treated in clinical practice. We sought to further characterize the patients with minor stroke who were included in the National Institute of Neurological Disorders and Stroke trials. METHODS: Minor strokes were defined as National Institutes of Health Stroke Scale score ≤ 5 at baseline for this retrospective analysis, because this subgroup is most commonly excluded from treatment in clinical practice and trials. Clinical stroke syndromes were defined based on prespecified National Institutes of Health Stroke Scale item score clusters. Clinical outcomes were reviewed generally and within these cluster subgroups. RESULTS: Only 58 cases had National Institutes of Health Stroke Scale scores of 0 to 5 in the National Institute of Neurological Disorders and Stroke trials (42 recombinant tissue plasminogen activator and 16 placebo), and 2971 patients were excluded from the trials due to "rapidly improving" or "minor symptoms" as the primary reason. No patients were enrolled with isolated motor symptoms, isolated facial droop, isolated ataxia, dysarthria, isolated sensory symptoms, or with only symptoms/signs not captured by the National Institutes of Health Stroke Scale score (ie, National Institutes of Health Stroke Scale=0). There were ≤ 3 patients with each of the other isolated deficits enrolled in the trial. CONCLUSIONS: The National Institute of Neurological Disorders and Stroke trials excluded a substantial number of strokes with minor presentations, those that were included were small in number, and conclusions about outcomes based on specific syndromes cannot be drawn. Further prospective, systematic study of this subgroup is needed.
Authors: I L Katzan; A J Furlan; L E Lloyd; J I Frank; D L Harper; J A Hinchey; J P Hammel; A Qu; C A Sila Journal: JAMA Date: 2000-03-01 Impact factor: 56.272
Authors: D Cocho; R Belvís; J Martí-Fàbregas; L Molina-Porcel; J Díaz-Manera; A Aleu; J Pagonabarraga; D García-Bargo; A Mauri; J-L Martí-Vilalta Journal: Neurology Date: 2005-02-22 Impact factor: 9.910
Authors: Eric E Smith; Abdul R Abdullah; Iva Petkovska; Eric Rosenthal; Walter J Koroshetz; Lee H Schwamm Journal: Stroke Date: 2005-10-06 Impact factor: 7.914
Authors: Urs Fischer; Adrian Baumgartner; Marcel Arnold; Krassen Nedeltchev; Jan Gralla; Gian Marco De Marchis; Liliane Kappeler; Marie-Luise Mono; Caspar Brekenfeld; Gerhard Schroth; Heinrich P Mattle Journal: Stroke Date: 2010-02-25 Impact factor: 7.914
Authors: Dawn Kleindorfer; Brett Kissela; Alex Schneider; Daniel Woo; Jane Khoury; Rosemary Miller; Kathleen Alwell; James Gebel; Jerzy Szaflarski; Arthur Pancioli; Edward Jauch; Charles Moomaw; Rakesh Shukla; Joseph P Broderick Journal: Stroke Date: 2004-01-22 Impact factor: 7.914
Authors: Timothy John Ingall; William Michael O'Fallon; Kjell Asplund; Lewis Robert Goldfrank; Vicki S Hertzberg; Thomas Arthur Louis; Teresa J Hengy Christianson Journal: Stroke Date: 2004-09-02 Impact factor: 7.914
Authors: Sara K Rostanski; Zachary Shahn; Mitchell S V Elkind; Ava L Liberman; Randolph S Marshall; Joshua I Stillman; Olajide Williams; Joshua Z Willey Journal: Stroke Date: 2017-05-23 Impact factor: 7.914
Authors: Joshua Z Willey; Joshua Stillman; Juan A Rivolta; Julio Vieira; Margaret M Doyle; Guillermo Linares; Adrian Marchidann; Mitchell S V Elkind; Bernadette Boden-Albala; Randolph S Marshall Journal: Int J Stroke Date: 2011-11-22 Impact factor: 5.266
Authors: Adnan I Qureshi; Foad Abd-Allah; Aitziber Aleu; John J Connors; Ricardo A Hanel; Ameer E Hassan; Haitham M Hussein; Nazli A Janjua; Rakesh Khatri; Jawad F Kirmani; Mikael Mazighi; Heinrich P Mattle; Jefferson T Miley; Thanh N Nguyen; Gustavo J Rodriguez; Qaisar A Shah; Adnan H Siddiqui; Jose I Suarez; M Fareed K Suri; Reha Tolun Journal: J Vasc Interv Neurol Date: 2014-05
Authors: Shadi Yaghi; Charlotte Herber; Joshua Z Willey; Howard F Andrews; Amelia K Boehme; Randolph S Marshall; Ronald M Lazar; Bernadette Boden-Albala Journal: J Neurol Sci Date: 2015-09-02 Impact factor: 3.181
Authors: Robert A Frank; Santanu Chakraborty; Trevor McGrath; Alexander Mungham; James Ross; Dar Dowlatshahi; Michel Shamy; Grant Stotts Journal: Neuroradiol J Date: 2018-05-03