In-hospital mortality and clinical course of 20,891 patients with suspected acute myocardial infarction randomised between alteplase and streptokinase with or without heparin. The International Study Group.
In a study with 2 x 2 factorial design, 20,891 patients with suspected acute myocardial infarction of less than 6 h duration (12,490 from the GISSI-2 trial and 8401 recruited elsewhere) were randomly allocated to alteplase (recombinant tissue plasminogen activator, tPA) or streptokinase (SK) and to subcutaneous heparin, beginning 12 h after the start of thrombolytic therapy or no heparin. The protocol recommended that, in the absence of specific contraindications, all patients should receive aspirin and intravenous beta-blockade as soon as possible. No significant differences in hospital mortality were found between tPA and SK (8.9% versus 8.5%) or between heparin and no heparin (8.5% versus 8.9%). The incidence of major cardiac complications was also very similar in the different groups. For non-cardiac complications significant differences between the treatment groups were observed: more strokes were reported with tPA than with SK (1.3% versus 1%) while more major bleeds occurred with SK than with tPA (0.6% versus 0.9%). Subcutaneous heparin was likewise associated with an excess of major bleeds (1.0% with heparin versus 0.5% without heparin) but did not affect the incidence of stroke or reinfarction.
D000368:Aged; D002561:Cerebrovascular Disorders / Q000209:etiology; D015331:Cohort Studies; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006760:Hospitalization; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D009203:Myocardial Infarction / Q000150:complications / Q000188:drug therapy / Q000401:mortality*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012008:Recurrence; D013300:Streptokinase / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods*; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D006493:Heparin; D013300:Streptokinase; D010959:Tissue Plasminogen Activator