Intravenous Thrombolysis With Recombinant Tissue Plasminogen Activator for Acute Hemispheric Stroke: The European Cooperative Acute Stroke Study (ECASS)

JAMA: The Journal of the American Medical Association

Volumn 274, Issue 13, 1995, Pages 1017-1025

  Hacke, Werner ^a   Kaste, Markku ^a   Fieschi, Cesare ^a   Toni, Danilo ^a   Lesaffre, Emmanuel ^a   Von Kummer, Rüdiger ^a   Boysen, Gudrun ^a   Bluhmki, Erich ^a   Höxter, Godehard ^a   Mahagne, Marie Helene ^a   Hennerici, Michael ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ALTEPLASE;

ADULT; AGED; ARTICLE; BLOOD CLOT LYSIS; BRAIN HEMORRHAGE; BRAIN SCINTISCANNING; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MEGADOSE; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ACUTE DISEASE; ADULT; AGED; BRAIN; CEREBROVASCULAR DISORDERS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; LENGTH OF STAY; MALE; MIDDLE AGED; RECOMBINANT PROTEINS; SEVERITY OF ILLNESS INDEX; SURVIVAL ANALYSIS; THROMBOLYTIC THERAPY; TISSUE PLASMINOGEN ACTIVATOR; TOMOGRAPHY, X-RAY COMPUTED;

EID: 0029050323     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.1995.03530130023023     Document Type: Article

References (68)

1. Wardlaw J, Warlow C. Thrombolysis in acute ischemic stroke: does it work? Stroke. 1992;23:1826-1839.
2. Hacke W. Thrombolytic therapy in acute ischemic stroke: an update. Fibrinolysis. 1994;8:216-220.
3. del Zoppo GJ, Pessin M, Mori E, Hacke W. Thrombolytic intervention in acute thrombotic and embolic stroke. Semin Neurol. 1991;11:368-384.
4. Zeumer H, Hacke W, Ringelstein E. Intra-arterial thrombolysis in vertebrobasilar thromboembolic disease. AJNR Am J Neuroradiol. 1983;4: 401-404.
5. Zeumer H. Survey of progress: vascular recanalizing techniques in interventional neuroradiology. J Neurol. 1985;231:287-294.
6. Zeumer H, Freitag H, Grzyka U, Neunzig H. Local intra-arterial fibrinolysis in acute vertebrobasilar occlusion: Technical developments and recent results. Neuroradiology. 1989;31:336-340.
7. Zeumer H, Freitag H, Zanella F, Thie A, Arning C. Local intra-arterial fibrinolytic therapy in patients with stroke: urokinase vs recombinant tissue plasminogen activator (rt-PA). Neuroradiology. 1993;35:159-162.
8. Mori E, Tabuchi M, Yoshida T, Yamadori A. Intracarotid urokinase with thromboembolic occlusion of the middle cerebral artery. Stroke. 1988;19: 802-812.
9. Hacke W, Zeumer H, Ferbert A, Brückmann H, del Zoppo GJ. Intra-arterial thrombolytic therapy improves outcome in patients with acute vertebrobasilar occlusive disease. Stroke. 1988;19:1216-1222.
10. Bockenheimer S, Reinhuber F, Mohs C. Intra-arterielle Thrombolyse hirnversorgender Gefäβe. Radiologie. 1991;31:210-215.
11. del Zoppo GJ, Ferbert A, Otis S, et al. Local intra-arterial fibrinolytic therapy in acute carotid territory stroke: a pilot study. Stroke. 1988;19:307-313.
12. Matsumoto K, Satoh K. Topical intraarterial urokinase infusion for acute stroke. In: Hacke W, del Zoppo GJ, Hirschberg M, eds. Thrombolytic Therapy in Acute Ischemic Stroke. New York, NY: Springer Verlag; 1991:207-212.
13. Möbius E, Berg-Dammer E, Kühne D, Kunitsch G, Nahser H. Lokale intraarterielle fibrinolyse bei A. basilaris Verschluss mit progredientem Hirnstamminfarkt. Akt Neurol. 1989;16:184-190.
14. Nenci G, Gresele P, Taramelli M. Thrombolytic therapy for thromboembolism of vertebrobasilar artery. Angiology. 1983;34:561-571.
15. Brott T, Haley C, Levy D, Barsan W, Broderick J. Urgent therapy for stroke, part I: pilot study of tissue plasminogen activator administered within 90 minutes. Stroke. 1992;23:632-640.
16. Haley E, Brott T, Sheppard G, et al. Pilot randomized trial of tissue plasminogen activator in acute ischemic stroke. Stroke. 1993;24:1000-1004.
17. von Kummer R, Hacke W. Safety and efficacy of intravenous tissue plasminogen activator and heparin in acute middle cerebral artery stroke. Stroke. 1992;23:646-652.
18. Yamaguchi T, Hayakawa T, Kiuchi H, and the Japanese Thrombolysis in Stroke Group. Intravenous tissue plasminogen activator ameliorates the outcome of hyperacute embolic stroke. Cerebrovasc Dis. 1993;3:269.
19. Mori E, Yoneda Y, Tabuchi M, et al. Intravenous recombinant tissue plasminogen activator in acute carotid artery territory stroke. Neurology. 1992;42:976-982.
20. Hennerici M, Hacke W, von Kummer R, Hornig C, Zangemeister W. Intravenous tissue plasminogen activator for the treatment of acute thromboembolic ischemia. Cerebrovasc Dis. 1991;1:124-128.
21. del Zoppo GJ, Poeck K, Pessin M, et al. Recombinant tissue plasminogen activator in acute thrombotic stroke. Ann Neurol. 1992;32:78-86.
22. Fieschi C, Argentino C, Lenzi G, et al. Therapeutic window for pharmocological treatment in acute focal cerebral ischemia. Ann N Y Acad Sci. 1988;522:662-666.
23. Grotta J. Medical and surgical therapy for cerebrovascular disease. N Engl J Med. 1987;315: 1505-1516.
24. von Kummer R, Meyding-Lamade U, Forsting M, et al. Sensitivity and prognostic value of early CT in occlusion of the middle cerebral artery trunk. AJNR Am J Neuroradiol. 1994;15:9-15.
25. Ringelstein E, Biniek R, Weiller C, et al. Type and extent of hemispheric brain infarctions and clinical outcome in early and delayed middle cerebral artery recanalization. Neurology. 1992;42:289-298.
26. Forsting M, Krieger D, von Kummer R, Hacke W, Sartor K. The prognostic value of collateral blood flow in acute middle cerebral artery occlusion. In: del Zoppo GJ, Mori E, Hacke W, eds. Thrombolytic Therapy in Acute Ischemic Stroke II. New York, NY: Springer Verlag; 1993:160-167.
27. Casto L, Moschini L, Camerlingo M, et al. Local intraarterial thrombolysis for acute stroke in the carotid artery territories. Acta Neurol Scand. 1992; 86:308-311.
28. Wolpert S, Bruckmann H, Greenlee R, et al. Neuroradiologic evaluation of patients with acute stroke treated with recombinant tissue plasminogen activator. AJNR Am J Neuroradiol. 1993;14: 3-13.
29. Bozzao L, Fantozzi L, Bastianello S, Bozzao A, Fieschi C. Early collateral blood supply and late parenchymal brain damage in patients with middle cerebral artery occlusion. Stroke. 1989;20:735-740.
30. Pessin M, del Zoppo GJ, Estol C. Thrombolytic agents in the treatment of stroke. Clin Neuro Pharmacol. 1990;13:271-289.
31. Levy D, Brott T, Haley E, Marler J. Factors related to intracranial hematoma formation in patients receiving tPA for acute ischemic stroke. Stroke. 1994;25:291-297.
32. Boysen G, Hacke W. European Cooperative Acute Stroke Study (ECASS): study design and progress report. Eur J Neurol. 1995;1:213-219.
33. Bastianello S, Pierallini A, Colonnese C, et al. Hyperdense middle cerebral artery CT sign: comparison with angiography in the acute phase of ischemic supratentorial infarction. Neuroradiology. 1991;33:207-211.
34. Leys D, Pruvo J, Godefroy O, Rondepierre P, Leclerc X. Prevalence and significance of hyperdense middle cerebral artery in acute stroke. Stroke. 1992;23:317-324.
35. Tomsick T, Brott T, Olinger C, Barsan W, Spilker J. Hyperdense middle cerebral artery: incidence and quantitative significance. Neuroradiology. 1989; 31:312-315.
36. Fieschi C, Argentino C, Lenzi G, et al. Clinical and instrumental evaluation of patients with ischemic stroke within the first six hours. J Neurol Sci. 1989;91:311-321.
37. The rt-PA in Acute Stroke Study Group. An open safety/efficacy trial of rt-PA in acute thromboembolic stroke: final report. Stroke. 1991;22:153. Abstract.
38. Lesaffre E, Scheys I, Fröhlich J, Bluhmki E. Calculation of power and sample size with bounded outcome scores. Stat Med. 1993;12:1063-1078.
39. Mahoney F, Barthel D. Functional evaluation: The Barthel Index. Md Med J. 1965;14:61-65.
40. Asplund K, Eriksson S, Hägg E. Multicenter trial of hemodilution in acute ischemic stroke. Acta Neurol Scand. 1986;73:530-538.
41. Lindström E, Boysen G, Christiansen LW, et al. Reliability of Scandinavian Neurological Stroke Scale. Cerebrovasc Dis. 1991;1:103-107.
42. Brott T, Adams H, Olinger C, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864-870.
43. Senn S. Testing for baseline balance in clinical trials. Stat Med. 1994;13:1715-1726.
44. Pocock S, Geller N, Tsiatis A. The analysis of multiple endpoints in clinical trials. Biometrics. 1987; 43:487-498.
45. Gupta S. Probability integrals of multivariate normal and multivariate transformal analysis. Ann Math Stat. 1963;34:792-828.
46. Toni D, Fiorelli M, Gentile M, et al. Progressing neurological deficit secondary to acute ischemic stroke: a study on predictability, pathogenesis and prognosis. Arch Neurol. 1995;52:670-675.
47. Toni D, Fiorelli M, Bastianello S, et al. Haemorrhagic transformation of brain infarct: predictability in the first five hours from stroke onset and influence on clinical outcome. Neurology. In press.
48. Rankin J. Cerebral vascular accidents in patients over age of 60, II: prognosis. Scott Med J. 1957;2:200-215.
49. Granger C, Hamilton B, Gresham G, Kramer A. The stroke rehabilitation outcome study, part II: relative merits of the total Barthel Index score and a four-item subscore in predicting patients outcomes. Arch Phys Med Rehabil. 1989;70:100-103.
50. Swieten JV, Koudstaal P, Visser M, Schouten H, Gijn JV. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604-607.
51. Taub N, Wolfe C, Richardson E, Burney P. Predicting the disability of first-time stroke sufferers at 1 year: 12-month follow-up of a population-based cohort in southeast England. Stroke. 1994; 25:352-357.
52. Orgogozo J, Dartigues J. Methodology of clinical trials in acute cerebral ischemia: survival, functional and neurological outcome measures. Cerebrovasc Dis. 1991;1:100-111.
53. Kaste M, Palomäki H, Sarna S. Where and how should elderly stroke patients be treated? a randomized trial. Stroke. 1995;26:249-253.
54. Argentino C, Sacchetti M, Toni D, Savoini G, D'Arcangelo E. GM1 ganglioside therapy in acute ischemic stroke. Stroke. 1989;20:1143-1149.
55. Mohr J, Orgogozo J, Harrison M, et al. Meta-analysis of oral nimodipine trials in acute ischemic stroke. Cerebrovasc Dis. 1994;4:197-203.
56. The Hemodilution in Stroke Study Group. Hypervolemic hemodilution treatment of acute stroke: results of a randomized multicenter trial using pentastarch. Stroke. 1989;20:317-323.
57. Kaste M, Fogelholm R, Erila T, et al. A randomized, double-blind, placebo controlled trial of nimodipine in acute ischemic stroke. Stroke. 1994; 25:1348-1353.
58. Silver F, Norris J, Lewis A, Hachinski V. Early mortality following stroke: a prospective review. Stroke. 1984;15:492-496.
59. Koudstaal P, Stibbe J, Vermeuelen M. Fatal ischaemic brain oedema after early thrombolysis with tissue plasminogen activator in acute stroke. BMJ. 1988;297:1571-1574.
60. Ropper A, Shafran B. Brain edema after stroke: clinical syndrome and intracranial pressure. Arch Neurol. 1984;41:26-29.
61. Hacke W, Schwab S, DeGeorgia M. Intensive care of acute ischemic stroke. Cerebrovasc Dis. 1995; 5:385-392.
62. Hornig C, Dorndorf W, Agnoli A. Hemorrhagic cerebral infarction: a prospective study. Stroke. 1986; 17:179-185.
63. Okada Y, Yamaguchi T, Minematsu K, et al. Hemorrhagic transformation in cerebral embolism. Stroke. 1989;20:598-603.
64. Babikian V, Kase C, Pessin M. Intracerebral hemorrhage in stroke patients anticoagulated with heparin. Stroke. 1989;29:1500-1503.
65. Hacke W. Thrombolysis, stroke subtypes and embolus type. In: del Zoppo GJ, Mori E, Hacke W, eds. Thrombolytic Therapy in Acute Ischemic Stroke II. New York, NY: Springer Verlag; 1993:151-159.
66. Gore J, Sloan M, Price T, et al. Intracerebral hemorrhage, cerebral infarction, and subdural hematoma after acute myocardial infarction and thrombolytic therapy in the Thrombolysis in Myocardial Infarction Study. Circulation. 1991;83:448-459.
67. Smalling R, Schumacher R, Morris D. et al. Improved infarct-related arterial patency after high dose, weight-adjusted, rapid infusion of tissue-type plasminogen activator in myocardial infarction: results of a multicenter randomized trial of two dosage regimens. J Am Coll Cardiol. 1990;15:915-921.
68. Hommel M, Boissel P, Cornu C, et al. Termination of trial of streptokinase in severe acute ischaemic stroke. Lancet. 1995;345:57.