(Stroke. 1997;28:2119-2125.)
© 1997 American Heart Association, Inc.
Articles |
Generalized Efficacy of t-PA for Acute Stroke
Subgroup Analysis of the NINDS t-PA Stroke Trial
Correspondence to Dr Patrick Lyden (127), Departments of Neuroscience, UCSD School of Medicine and Neurology, Veterans Administration Medical Center at San Diego, 3350 La Jolla Village Dr, San Diego, CA 92161. E-mail plyden{at}ucsd.edu
Background and Purpose We sought to identify subgroups of stroke patients in whom thrombolytic therapy is particularly hazardous or efficacious.
Methods We conducted a post hoc subgroup analysis of a randomized, double-blind, placebo-controlled clinical trial of intravenous tissue plasminogen activator (t-PA) for stroke patients presenting within 3 hours after symptom onset. Before treatment, historical, physical, and laboratory findings were summarized. We identified variables that might predict outcome and/or differential response to t-PA therapy. Outcome was measured with four stroke rating scales administered 3 months after treatment. Statistical significance was assessed with a global outcome procedure that considers the results of all four scales simultaneously. Using regression analysis, we compared the information collected before treatment with the global outcome. Multivariable procedures were used to find information that could guide selection of patients for t-PA therapy.
Results No pretreatment information significantly affected patients' response to t-PA. The power of the model to detect a treatment interaction was greater than 90%, and therefore the probability of a type II error is very low. Apart from t-PA therapy, outcome was related to age-by-deficit severity interaction, diabetes, age-by-blood pressure interaction, and early CT findings. These variables and interactions altered long-term patient outcome irrespective of t-PA treatment but did not alter the likelihood of responding favorably to t-PA therapy.
Conclusions Patients should be selected for t-PA thrombolysis according to the guidelines published in the report of the NINDS t-PA Stroke Trial. Further subselection of patients, such as by age or stroke severity, is not supported by our post hoc analysis.
Key Words: thrombolytic therapy • cerebral ischemia • clinical trials • plasminogen activators
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P. Lyden, M. Jacoby, J. Schim, G. Albers, P. Mazzeo, T. Ashwood, A. Nordlund, and T. Odergren The Clomethiazole Acute Stroke Study in tissue-type plasminogen activator-treated stroke (CLASS-T): Final results Neurology, October 9, 2001; 57(7): 1199 - 1205. [Abstract] [Full Text] [PDF]
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A. M. Demchuk, D. Tanne, M. D. Hill, S. E. Kasner, S. Hanson, M. Grond, and S. R. Levine Predictors of good outcome after intravenous tPA for acute ischemic stroke Neurology, August 14, 2001; 57(3): 474 - 480. [Abstract] [Full Text] [PDF]
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D. J. Gladstone and S. E. Black Update on intravenous tissue plasminogen activator for acute stroke: from clinical trials to clinical practice Can. Med. Assoc. J., August 1, 2001; 165(3): 311 - 317. [Abstract] [Full Text] [PDF]
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S. D. Reed, S. C. Cramer, D. K. Blough, K. Meyer, J. G. Jarvik, and D. Z. Wang Treatment With Tissue Plasminogen Activator and Inpatient Mortality Rates for Patients With Ischemic Stroke Treated in Community Hospitals Editorial Comment Stroke, August 1, 2001; 32(8): 1832 - 1840. [Abstract] [Full Text] [PDF]
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P. D. Lyden, M. Lu, S. R. Levine, T. G. Brott, J. Broderick, and R. Cote A Modified National Institutes of Health Stroke Scale for Use in Stroke Clinical Trials : Preliminary Reliability and Validity Editorial Comment : The NIH Stroke Scale: Is Simpler Better? Stroke, June 1, 2001; 32(6): 1310 - 1317. [Abstract] [Full Text] [PDF]
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J. C. Grotta, K. M. A. Welch, S. C. Fagan, M. Lu, M. R. Frankel, T. Brott, S. R. Levine, P. D. Lyden, and P. D. Lyden Clinical Deterioration Following Improvement in the NINDS rt-PA Stroke Trial Stroke, March 1, 2001; 32(3): 661 - 668. [Abstract] [Full Text] [PDF]
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 A C Pereira, P J Martin, and E A Warburton Thrombolysis in acute ischaemic stroke Postgrad. Med. J., March 1, 2001; 77(905): 166 - 171. [Full Text]
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E. COMMITTEE OF THE ASITN Intraarterial Thrombolysis: Ready for Prime Time? AJNR Am. J. Neuroradiol., January 1, 2001; 22(1): 55 - 58. [Full Text] [PDF]
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H. Yanamoto, I. Nagata, Y. Niitsu, Z. Zhang, J.-H. Xue, N. Sakai, H. Kikuchi, and C. Iadecola Prolonged Mild Hypothermia Therapy Protects the Brain Against Permanent Focal Ischemia Editorial Comment Stroke, January 1, 2001; 32(1): 232 - 239. [Abstract] [Full Text] [PDF]
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P.T. Akins, C. Delemos, D. Wentworth, J. Byer, S.J. Schorer, and a. R.P. Atkinson Can emergency department physicians safely and effectively initiate thrombolysis for acute ischemic stroke? Neurology, December 26, 2000; 55(12): 1801 - 1805. [Abstract] [Full Text] [PDF]
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J. R. Marler, B. C. Tilley, M. Lu, T. G. Brott, P. C. Lyden, J. C. Grotta, J. P. Broderick, S. R. Levine, M. P. Frankel, S. H. Horowitz, et al. Early stroke treatment associated with better outcome: The NINDS rt-PA Stroke Study Neurology, December 12, 2000; 55(11): 1649 - 1655. [Abstract] [Full Text] [PDF]
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NINDS Effect of Intravenous Recombinant Tissue Plasminogen Activator on Ischemic Stroke Lesion Size Measured by Computed Tomography Stroke, December 1, 2000; 31(12): 2912 - 2919. [Abstract] [Full Text] [PDF]
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M. Fisher and W. Schaebitz An Overview of Acute Stroke Therapy: Past, Present, and Future Arch Intern Med, November 27, 2000; 160(21): 3196 - 3206. [Full Text] [PDF]
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R. Ernst, A. Pancioli, T. Tomsick, B. Kissela, D. Woo, D. Kanter, E. Jauch, J. Carrozzella, J. Spilker, and J. Broderick Combined Intravenous and Intra-Arterial Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke Stroke, November 1, 2000; 31(11): 2552 - 2557. [Abstract] [Full Text] [PDF]
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M. R. Frankel, L. B. Morgenstern, T. Kwiatkowski, M. Lu, B. C. Tilley, J. P. Broderick, R. Libman, S. R. Levine, and T. Brott Predicting prognosis after stroke: A placebo group analysis from the National Institute of Neurological Disorders and Stroke rt-PA Stroke Trial Neurology, October 10, 2000; 55(7): 952 - 959. [Abstract] [Full Text] [PDF]
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T. Brott and J. Bogousslavsky Treatment of Acute Ischemic Stroke N. Engl. J. Med., September 7, 2000; 343(10): 710 - 722. [Full Text] [PDF]
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J. Oliveira-Filho, H. Ay, P. W. Schaefer, F. S. Buonanno, Y. Chang, R. G. Gonzalez, and W. J. Koroshetz Diffusion-Weighted Magnetic Resonance Imaging Identifies the "Clinically Relevant" Small-Penetrator Infarcts Arch Neurol, July 1, 2000; 57(7): 1009 - 1014. [Abstract] [Full Text] [PDF]
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M. A. Kalafut, D. L. Schriger, J. L. Saver, and S. Starkman Detection of Early CT Signs of >1/3 Middle Cerebral Artery Infarctions : Interrater Reliability and Sensitivity of CT Interpretation by Physicians Involved in Acute Stroke Care Stroke, July 1, 2000; 31(7): 1667 - 1671. [Abstract] [Full Text] [PDF]
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W. M. Clark, G. W. Albers, K. P. Madden, and S. Hamilton The rtPA (Alteplase) 0- to 6-Hour Acute Stroke Trial, Part A (A0276g) : Results of a Double-Blind, Placebo-Controlled, Multicenter Study Stroke, April 1, 2000; 31(4): 811 - 816. [Abstract] [Full Text] [PDF]
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G. W. Albers, V. E. Bates, W. M. Clark, R. Bell, P. Verro, and S. A. Hamilton Intravenous Tissue-Type Plasminogen Activator for Treatment of Acute Stroke: The Standard Treatment with Alteplase to Reverse Stroke (STARS) Study JAMA, March 1, 2000; 283(9): 1145 - 1150. [Abstract] [Full Text] [PDF]
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D. Tanne, M. J. Gorman, V. E. Bates, S. E. Kasner, P. Scott, P. Verro, J. R. Binder, J. M. Dayno, L. R. Schultz, and S. R. Levine Intravenous Tissue Plasminogen Activator for Acute Ischemic Stroke in Patients Aged 80 Years and Older : The tPA Stroke Survey Experience Stroke, February 1, 2000; 31(2): 370 - 375. [Abstract] [Full Text] [PDF]
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K. C. Johnston, A. F. Connors Jr, D. P. Wagner, W. A. Knaus, X.-Q. Wang, and E. C. Haley Jr A Predictive Risk Model for Outcomes of Ischemic Stroke Stroke, February 1, 2000; 31(2): 448 - 455. [Abstract] [Full Text] [PDF]
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H. Yanamoto, I. Nagata, I. Nakahara, N. Tohnai, Z. Zhang, H. Kikuchi, and C. Iadecola Combination of Intraischemic and Postischemic Hypothermia Provides Potent and Persistent Neuroprotection Against Temporary Focal Ischemia in Rats • Editorial Comment Stroke, December 1, 1999; 30(12): 2720 - 2726. [Abstract] [Full Text] [PDF]
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K. S. Wong Risk Factors for Early Death in Acute Ischemic Stroke and Intracerebral Hemorrhage : A Prospective Hospital-Based Study in Asia Stroke, November 1, 1999; 30(11): 2326 - 2330. [Abstract] [Full Text] [PDF]
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J. C. Grotta, D. Chiu, M. Lu, S. Patel, S. R. Levine, B. C. Tilley, T. G. Brott, E. C. Haley Jr, P. D. Lyden, R. Kothari, et al. Agreement and Variability in the Interpretation of Early CT Changes in Stroke Patients Qualifying for Intravenous rtPA Therapy Stroke, August 1, 1999; 30(8): 1528 - 1533. [Abstract] [Full Text] [PDF]
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J. A. Zivin Thrombolytic stroke therapy: Past, present, and future Neurology, July 1, 1999; 53(1): 14 - 14. [Abstract] [Full Text] [PDF]
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H. P. Adams Jr., P. H. Davis, E. C. Leira, K.-C. Chang, B. H. Bendixen, W. R. Clarke, R. F. Woolson, and M. D. Hansen Baseline NIH Stroke Scale score strongly predicts outcome after stroke: A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST) Neurology, July 1, 1999; 53(1): 126 - 126. [Abstract] [Full Text]
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