Ischemic cerebral infarction after rt-PA and heparin therapy for acute myocardial infarction: The TIMI-II pilot and randomized clinical trial combined experience

Stroke

Volumn 28, Issue 6, 1997, Pages 1107-1114

  Sloan, Michael A ^a,b   Price, Thomas R ^a,b   Terrin, Michael L ^a   Forman, Sandra ^a   Gore, Joel M ^c   Chaitman, Bernard R ^h   Hodges, Morrison ^d   Mueller, Hiltrud ^e   Rogers, William J ^f   Knatterud, Genell L ^a   Braunwald, Eugene ^g  

^a MARYLAND MEDICAL RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^d UNIVERSITY OF MINNESOTA   (United States)

^e ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^f UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^g BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^h NONE

Author keywords

Cerebral infarction; Heparin; Myocardial infarction; Thrombolytic therapy

Indexed keywords

ALTEPLASE; HEPARIN;

ACUTE HEART INFARCTION; ADULT; AGED; ARTICLE; BLEEDING; BRAIN INFARCTION; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FIBRINOLYTIC THERAPY; HEPARINIZATION; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

EID: 0030915068     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.STR.28.6.1107     Document Type: Article

References (88)

1. Thompson PF, Robinson JS. Stroke after acute myocardial infarction: relation to infarct size. Br Med J. 1978;2:457-459.
2. Komrad MS, Coffey CE, Coffey MS, McKinnis R, Massey EW, Califf RM. Myocardial infarction and stroke. Neurology. 1984;34: 1403-1409.
3. Drapkin A, Merskey C. Anticoagulant therapy after acute myocardial infarction: relation of therapeutic benefit to patient's age, sex and severity of infarction. JAMA. 1972;222:541-548.
4. Veterans Administration Cooperative Study. Anticoagulants in acute myocardial infarction: results of a cooperative clinical trial. JAMA. 1973;225:724-729.
5. Report of the Working Party, Medical Research Council. Assessment of short-term anticoagulant administration after cardiac infarction. Br Med J. 1969;1:335-342.
6. Hart RG. Prevention and treatment of cardioembolic stroke. In: Furlan AJ, ed. The Heart and Stroke. Berlin, Germany: Springer-Verlag; 1987:17-36.
7. Cranston RE, Wolfson MA, Buchsbaum HW, Feinberg WM, Barreuther A. Plasminogen activator and cerebral infarction. Ann Intern Med. 1988;108:766. Letter.
8. Stafford PJ, Strachan CJL, Vincent R, Chamberlain DA. Multiple microemboli after disintegration of clot during thrombolysis for acute myocardial infarction. Br Med J. 1989;299:1310-1312.
9. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet. 1986;1:397-402.
10. Rovelli F, Devita C, Feruglio GA, Lotta A, Selvini A, Tognini G, and GISSI Investigators. GISSI Trial: early results and late follow-up. J Am Coll Cardiol. 1987;10(suppl):33B-39B.
11. Maggioni AP, Franzosi MG, Farnia ML, Santoro R, Celani MG, Ricci S, Tognini G, for the GISSI Group. Cerebrovascular events after myocardial infarction: analysis of the GISSI trial. Br Med J. 1991;302:1428-1431.
12. EMERAS (Estudio Multicéntrico Estreptoquinasa Repúblicas de America del Sur) Collaborative Group. Randomized trial of late thrombolysis in patients with suspected acute myocardial infarction. Lancet. 1993;342:767-772.
13. ISIS-2 (Second International Study of Infarct Survival). Randomized trial of intravenous streptokinase, oral aspirin, both or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988;2:349-360.
14. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. GISSI-2: a factorial randomized trial of alteplase versus streptokinase and heparin versus no heparin among 12,490 patients with myocardial infarction. Lancet. 1990;336:65-71.
15. International Study Group. In-hospital mortality and clinical course of 20,891 patients with suspected acute myocardial infarction randomized between alteplase and streptokinase with or without heparin. Lancet. 1990;336:71-75.
16. Maggioni AP, Franzosi MG, Santoro E, White H, Van de Werf F, Tognini G, the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico II (GISSI-II), and the International Study Group. The risk of stroke in patients with acute myocardial infarction after thrombolytic and antithrombotic treatment. N Engl J Med. 1992;327:1-6.
17. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group. ISIS-3: a randomized comparison of streptokinase vs. tissue plasminogen activator vs. anistreplase and of aspirin plus heparin vs. aspirin alone among 41,299 cases of suspected acute myocardial infarctions. Lancet. 1992;339:753-770.
18. Gore JM, Granger CB, Simoons ML, Sloan MA, Weaver WD, White HD, Barbash GI, Van der Werf F, Aylward PE, Topol EJ, Califf RM, for the GUSTO-I Investigators. Stroke after thrombolysis: mortality and functional outcomes in the GUSTO-I trial. Circulation. 1995;92:2811-2818.
19. Wilcox RG, Olsson CG, Skene AM, von der Lippe G, Jensen G, Hampton JR. Trial of tissue plasminogen activator for mortality reduction in acute myocardial infarction: Anglo-Scandinavian Study of Early Thrombolysis (ASSET). Lancet. 1988;2:525-530.
20. Wilcox RG, von der Lippe G, Olsson CG, Jensen G, Skene AM, Hampton JR. Effects of alteplase on acute myocardial infarction: 6-month results from the ASSET Study. Lancet. 1990;335: 1175-1178.
21. LATE Study Group. Late assessment of thrombolytic efficacy (LATE) study with alteplase 6-24 hours after onset of acute myocardial infarction. Lancet. 1993;342:759-766.
22. Gore JM, Sloan M, Price TR, Randall AMY, Bovill E, Collen D, Forman S, Knatterud GL, Sopko G, Terrin ML, and the TIMI Investigators. Intracerebral hemorrhage, cerebral infarction, and subdural hematoma after acute myocardial infarction and thrombolytic therapy in the Thrombolysis in Myocardial Infarction Study: Thrombolysis in Myocardial Infarction, Phase II, Pilot and Clinical Trial. Circulation. 1991;83:448-459.
23. Longstreth WT, Litwin PE, Weaver WD, for the MITI Project Group. Myocardial infarction, thrombolytic therapy, and stroke: a community-based study. Stroke. 1993;24:587-590.
24. Vermeer F, Massberg I, Meyer J, Bar FW, Michels R, Tebbe U, Vanhove Ph, Barch H, Flohé L. Saruplase, a new fibrin-specific thrombolytic agent: efficacy and safety in the first 1000 patients. J Am Coll Cardiol. 1991;17(suppl):152A. Abstract.
25. Vermeer F, Bär F, Windeler J, Schenkel W. Saruplase, a new fibrin-specific thrombolytic agent: final results of the Pass Study (1698 patients). Circulation. 1993;88(suppl I):I-292. Abstract.
26. Rossi P, Bolognese L, on behalf of Urochinasi per via Sistemica nell'Infarcto Miocardico (USIM) Collaborative Group. Comparison of intravenous urokinase plus heparin versus heparin alone in acute myocardial infarction. Am J Cardiol. 1991;68:585-592.
27. Passamani E, Hodges M, Herman M, Grose R, Chaitman B, Rogers W, Forman S, Terrin M, Knatterud G, Robertson T, Braunwald E, for the TIMI Investigators. The Thrombolysis in Myocardial Infarction (TIMI) Phase II Pilot Study: tissue plasminogen activator followed by percutaneous transluminal coronary angioplasty. J Am Coll Cardiol. 1987;10(suppl):51B-64B.
28. TIMI Research Group. Immediate versus delayed catheterization and angioplasty following thrombolytic therapy for acute myocardial infarction: TIMI-IIA results. JAMA. 1988;260:2849-2858.
29. TIMI Study Group. Comparison of invasive and conservative strategies after treatment with intravenous tissue plasminogen activator in acute myocardial infarction: results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II Trial. N Engl J Med. 1989;320:618-627.
30. Chaves CJ, Caplan LR, Chung C-S, Tapia J, Amarenco P, Teal P, Wityk R, Estol C, Tettenborn B, Rosengart A, Vemmos K, DeWitt LD, Pessin MS. Cerebellar infarcts in the New England Medical Center Posterior Circulation Stroke Registry. Neurology. 1994;44: 1385-1390.
31. Koudstaal PJ, van Gijn J, Kappelle LJ, for the Dutch TIA Study Group. Headache in transient or permanent cerebral ischemia. Stroke. 1991;22:754-759.
32. Jørgensen HS, Jerpersen HF, Nakayama H, Raaschou HO, Olsen TS. Headache in stroke: the Copenhagen Stroke Study. Neurology. 1994;44:1793-1797.
33. Hart RG, Easton JD. Hemorrhagic infarcts. Stroke. 1986;17: 586-589.
34. Bogousslavsky J, Regli F, Uske A, Maeder P. Early spontaneous hematoma in cerebral infarct: is primary cerebral hemorrhage overdiagnosed? Neurology. 1991;41:837-840.
35. Sloan MA, Price TR. Intracranial hemorrhage following thrombolytic therapy for acute myocardial infarction. Semin Neurol. 1991;11:385-399.
36. Cerebral Embolism Task Force. Cardiogenic brain embolism. Arch Neurol. 1986;43:71-84.
37. Cerebral Embolism Task Force. Cardiogenic brain embolism: the second report of the Cerebral Embolism Task Force. Arch Neurol. 1989;46:727-743.
38. Mohr JP, Barnett HJM. Classification of ischemic strokes. In: Barnett HJM, Mohr JP, Stern BM, Yatsu FM, eds. Stroke: Pathophysiology, Diagnosis, and Management. New York, NY: Churchill Livingstone; 1986:286-291.
39. Foulkes MA, Wolf PA, Price TR, Mohr JP, Hier DB. Stroke Data Bank: design, methods, and baseline characteristics. Stroke. 1988; 19:547-554.
40. Kittner SJ, Sharkness CM, Price TR, Plotnick G, Dambrosia JM, Wolf PA, Mohr JP, Kase CS, Tuhrim S. Infarcts with a cardiac source of embolism in the NINCDS Stroke Data Bank: historical features. Neurology. 1990;40:281-284.
41. Kittner SJ, Sharkness CM, Sloan MA, Price TR, Dambrosia JM, Wolf PA, Mohr JP, Hier DB, Caplan LR. Infarcts with a cardiac source of embolism in the NINDS Stroke Data Bank: neurological examination. Neurology. 1992;42:299-302.
42. Bogousslavsky J, Cachin C, Regli F, Despland P-A, van Melle G, Kappenberger L. Cardiac sources of embolism and cerebral infarction: clinical consequences and vascular concomitants - the Lausanne Stroke Registry. Neurology. 1991;41:855-859.
43. Kittner SJ, Sharkness CM, Sloan MA, Price TR, Dambrosia JM, Tuhrim S, Wolf PA, Mohr JP, Hier DB. Features on initial computed tomographic scan of infarcts with a cardiac source of embolism in the NINDS Stroke Data Bank. Stroke. 1992;23: 1748-1751.
44. Johnson CJ, Kittner SJ, McCarter RJ, Sloan MA, Stern BJ, Buchholz D, Price TR. Interrater reliability of an etiologic classification of ischemic stroke. Stroke. 1995;26:46-51.
45. Gross CR, Shinar D, Mohr JP, Hier DB, Caplan LR, Price TR, Wolf PA, Kase CS, Fishman IG, Calengo S, Kunitz SC. Interobserver agreement in the diagnosis of stroke type. Arch Neurol. 1986;43:893-898.
46. Bodenheimer MM, Sauer D, Shareif B, Brown MW, Fleiss JL, Moss AJ. Relation between myocardial infarct location and stroke. J Am Coll Cardiol. 1994;24:61-66.
47. Bautista RED. Embolic stroke following thrombolytic therapy for myocardial infarction in a patient with preexisting ventricular thrombi. Stroke. 1995;26:324-325.
48. Sloan MA, Price TR, Petito CK, Randall AMY, Solomon RE, Terrin ML, Gore J, Collen D, Kleiman N, Feit F, Babb J, Herman M, Roberts WC, Sopko G, Bovill E, Forman S, Knatterud GL, for the TIMI Investigators. Clinical features and pathogenesis of intracerebral hemorrhage after rt-PA and heparin therapy for acute myocardial infarction: the TIMI II pilot and randomized trial combined experience. Neurology. 1995;45:649-658.
49. Kase C, Norrving B, Levine SR, Babikian VL, Chodosh EH, Wolf PA, Welch KMA. Cerebellar infarction: clinical and anatomic observations in 66 patients. Stroke. 1993;24:76-83.
50. Tettenborn B, Caplan LR, Sloan MA, Estol CJ, Pessin MS, DeWitt LD, Haley C, Price TR. Postoperative brainstem and cerebellar infarcts. Neurology. 1993;43:471-477.
51. Weinrich DJ, Burke JF, Pauletto FJ. Left ventricular mural thrombi complicating acute myocardial infarction. Ann Intern Med. 1984; 100:789-794.
52. Johannessen K-A, Nordrehaug JE, von der Lippe G. Left ventricular thrombosis and cerebrovascular accident in acute myocardial infarction. Br Heart J. 1984;51:553-556.
53. Asinger RW, Mikell FL, Elsperger J, Hodges M. Incidence of left ventricular mural thrombosis after acute transmural myocardial infarction: serial evaluation by two-dimensional echocardiography. N Engl J Med. 1981;305:297-302.
54. Friedman M, Kalbfleisch J, Brewer D, Slagle R, McEntee C, Conrad L, Hawkins H. Does intracoronary streptokinase following acute myocardial infarction prevent left ventricular thrombus formation. J Am Coll Cardiol. 1984;3:614. Abstract.
55. Keren A, Goldberg S, Gottlieb S, Klein J, Schuger C, Medina A, Tzivoni D, Stern S. Natural history of left ventricular thrombi: their appearance and resolution in the post-hospitalization period of acute myocardial infarction. J Am Coll Cardiol. 1990;15:790-800.
56. Friedman MJ, Carlson K, Marcus FI, Woolfenden JM. Clinical correlations in patients with acute myocardial infarction and left ventricular thrombosis detected by two-dimensional echocardiography. Am J Med. 1982;72:894-898.
57. Stratton JR, Resnick AD. Increased embolic risk in patients with left ventricular thrombi. Circulation. 1987;75:1004-1011.
58. Nordrehaug JE, Johannessen K-A, von der Lippe G. Usefulness of high-dose anticoagulants in preventing left ventricular thrombosis in acute myocardial infarction. Am J Cardiol. 1985;55:1491-1493.
59. SCATI (Studio sulla Calciparina nell'Angina e nella Trombosi ventriculorare nell'Infarcto) Group. Randomized controlled trial of subcutaneous calcium-heparin in acute myocardial infarction. Lancet. 1989;2:182-186.
60. Arvan D, Boscha K. Prophylactic anticoagulation for left ventricular thrombi after acute myocardial infarction: a prospective randomized trial. Am Heart J. 1987;113:688-693.
61. Eigler N, Maurer G, Shah PK. Effect of early systemic thrombolytic therapy on left ventricular mural thrombus formation in acute anterior myocardial infarction. Am J Cardiol. 1984;54:261-263.
62. Motro M, Barbash GI, Hod H, Roth A, Kaplinsky E, Laniado S, Keren G. Incidence of left ventricular thrombi formation after thrombolytic therapy with recombinant tissue plasminogen activator, heparin and aspirin for patients with acute myocardial infarction. Am Heart J. 1991;122:23-26.
63. Heik SAV, Kupper W, Harmon C, Bleifeld W, Koschyk DH, Waters D, Chen C. Efficacy of high dose intravenous heparin for treatment of left ventricular thrombi with high embolie risk. J Am Coll Cardiol. 1994;24:1305-1309.
64. Shaw PJ, Bates D, Cartlidge NEF, Heaviside D, Julian DG, Shaw DA. Early neurological complications of coronary artery bypass surgery. Br Med J. 1985;291:1384-1387.
65. Breuer AC, Furlan AJ, Hanson MR, Lederman RJ, Loop FD, Cosgrove DM. Central nervous system complications of coronary artery bypass graft surgery: prospective analysis of 421 patients. Stroke. 1983;14:682-687.
66. Hise JH, Nipper ML, Schnitker JC. Stroke associated with coronary artery bypass surgery. AJNR Am J Neuroradiol. 1991;12:811-814.
67. Gardner TJ, Horneffer PJ, Manolio TA, Pearson TA, Gott VL, Baumgartner WA, Borkon AM, Watkins L, Reitz BA. Stroke following coronary artery bypass grafting: a ten-year study. Ann Thorac Surg. 1985;40:574-581.
68. Breuer AC, Franco I, Marzewski D, Soto-Velasco J. Left ventricular thrombi seen by ventriculography are a significant risk factor for stroke in open-heart surgery. Ann Neurol. 1981;10:103-104. Abstract.
69. Breslau PJ, Fell G, Ivey TD, Bailey WW, Miller DW, Strandness DE Jr. Carotid arterial disease in patients undergoing coronary artery bypass operations. J Thorac Cardiovasc Surg. 1981;82: 765-767.
70. Turnipseed WD, Berkhoff HA, Belzer FO. Postoperative stroke in cardiac and peripheral vascular disease. Ann Surg. 1980;192: 365-368.
71. Sloan MA, Gore JM. Ischemic stroke and intracranial hemorrhage following thrombolytic therapy for acute myocardial infarction: a risk-benefit analysis. In: Gore JM, Becker RC, eds. A symposium: safety of thrombolytic agents. Am J Cardiol. 1992;69:21A-38A.
72. Gravlee GP, Hudspeth AS, Toole JF. Bilateral brachial paralysis from watershed infarction after coronary artery bypass. J Thorac Cardiovasc Surg. 1984;88:742-747.
73. Davis K, Kennedy JW, Kemp HG Jr, Judkins MP, Gosselin AJ, Killip T. Complications of coronary arteriography from the Collaborative Study of Coronary Artery Surgery (CASS). Circulation. 1979;59:1105-1112.
74. Adams DF, Abrams HL. Complications of coronary arteriography: a follow-up report. Cardiovasc Radiol. 1979;2:89-96.
75. Bredlau CE, Roubin GS, Leimgruber PP, Douglas JS, King SB, Grüentzig AR. In-hospital morbidity and mortality in patients undergoing elective coronary angioplasty. Circulation. 1985;72: 1044-1052.
76. Brown DL, Topol EJ. Stroke complicating percutaneous coronary revascularization. Am J Cardiol. 1993;72:1207-1209.
77. Ogata J, Yutani C, Imakita M, Ishibashi-Ueda H, Saku Y, Minematsu K, Sawada T, Yamaguchi T. Hemorrhagic infarct of the brain without reopening of the occluded arteries in cardioembolic stroke. Stroke. 1989;20:876-883.
78. Okada Y, Yamaguchi T, Minematsu K, Miyashita T, Sawada T, Sadoshima S, Fujishima M, Omae T. Hemorrhagic transformation in cerebral embolism. Stroke. 1989;20:598-603.
79. Lodder J, Krijne-Kubat B, van der Lugt PJM. Timing of autopsyproven hemorrhagic infarction with reference to cardioembolic stroke. Stroke. 1988;19:1482-1484.
80. Cerebral Embolism Study Group. Immediate anticoagulation of embolic stroke: brain hemorrhage and management options. Stroke. 1984;15:779-789.
81. Laureno R, Shields RW, Narayan T. The diagnosis and management of cerebral embolism and hemorrhagic infarction with sequential computerized cranial tomography. Brain. 1987;110: 93-105.
82. Fisher M, Zito JL, Siva A, DeGirolami U. Hemorrhagic infarction: a clinical and CT study. Stroke. 1984;15:192. Abstract.
83. Horning CR, Dorndorf W, Agnoli AL. Hemorrhagic cerebral infarction: a prospective study. Stroke. 1986;17:179-185.
84. Cerebral Embolism Study Group. Cardioembolic stroke, early anticoagulation, and brain hemorrhage. Arch Intern Med. 1987;147: 636-640.
85. Babikian VL, Kase CS, Pessin MS, Norrving B, Gorelick PB. Intracerebral hemorrhage in stroke patients anticoagulated with heparin. Stroke. 1989;20:1500-1503.
86. Pessin MS, Estol CJ, Lafranchise F, Caplan LR. Safety of anticoagulation after hemorrhagic infarction. Neurology. 1993;43: 1298-1303.
87. Wijdicks EFM, Jack CR. Intracerebral hemorrhage after fibrinolytic therapy for acute myocardial infarction. Stroke. 1993;24: 554-557.
88. Eisenberg PR, Sherman LA, Tiefenbrunn AJ, Ludbrook PA, Sobel BE, Jaffe AS. Sustained fibrinolysis after administration of rt-PA despite its short half life in the circulation. Thromb Haemost. 1987; 57:35-40.