Thrombolysis with intravenous human recombinant tissue-type plasminogen activator in acute myocardial infarction: the European experience.
The initial studies in Europe with tissue-type plasminogen activator (rt-PA) have been coordinated by a European Cooperative Study Group. By February 1987, 258 patients had been entered into comparative coronary patency trials of rt-PA versus streptokinase and rt-PA versus placebo (trials completed and published); 123 patients had entered a coronary patency trial of prolonged rt-PA infusion versus short-term rt-PA infusion (trial completed but results not yet published); and greater than 500 patients had been recruited for left ventricular function and infarct size trials comparing rt-PA with placebo and rt-PA alone with rt-PA plus immediate coronary angioplasty (studies still in progress). The first three studies used two chain rt-PA, 0.75 mg/kg, for the rt-PA versus streptokinase and rt-PA versus placebo studies and 40 or 80 mg for the short-term versus long-term study. The current studies are using single chain rt-PA in a dose of 100 mg (20 mg bolus, 40, 20 and 20 mg in succeeding hours). Coronary patency at angiography 90 minutes after the start of treatment was 70% for rt-PA and 55% for streptokinase, 1.5 million units, in the plasminogen activator versus streptokinase study (p = 0.054), 61% for rt-PA and 21% for placebo in the rt-PA versus placebo study (p less than 0.001). In the first three studies (251 patients allocated to rt-PA) there was one case of retroperitoneal hematoma, one of hematemesis and no cases of cerebral hemorrhage; 38 patients (15%) had a hematoma or bleeding related to arterial catheterization.(ABSTRACT TRUNCATED AT 250 WORDS)
D000800:Angioplasty, Balloon; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D004311:Double-Blind Method; D005060:Europe; D006801:Humans; D007262:Infusions, Intravenous; D009203:Myocardial Infarction / Q000188:drug therapy*; D010919:Placebos; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013300:Streptokinase / Q000008:administration & dosage; D013997:Time Factors; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D014654:Vascular Patency / Q000187:drug effects
D010919:Placebos; D011994:Recombinant Proteins; D013300:Streptokinase; D010959:Tissue Plasminogen Activator