Urochinasi per via Sistemica nell'Infarto Miocardico - USIM
A randomized trial of the effect of IV urokinase plus heparin vs heparin alone on early mortality.
Early mortality would be reduced from 12% in the control group to 10% in the urokinase group.
Patients Screened: 7,598
Patients Enrolled: 2,201
Mean Follow Up: In-hospital (9-16 days for >90% of patients)
Mean Patient Age: not reported; no age exclusion
Typical chest pain refractory to sublingual nitroglycerin lasting >=30 minutes <4 hours from sympton onset to recruitment ST segment shift >=0.1 mV in the peripheral leads of the ECG or >=0.2 mV in the chest leads
Bleeding complications Nonfatal cardiac events (recurrent MI, CHF)
Bolus of 1 million U urokinase at enrollment and 60 minutes, plus 10,000 U IV heparin vs 10,000 U IV heparin alone. Heparin infusion of 1,000 U/h for 48 hours in both arms; dose adjusted after 10 hours to maintain PTT 2-3 times control.
Mortality did not differ between the 2 groups (8% in urokinase group vs 8.3% in heparin group, p=NS). There was a trend for reduced mortality in patients with anterior infarction (10.3% vs 13.9%, p=0.09). No difference in in-hospital reinfarction occurred (UK 3.6% vs heparin 2.8%, p=NS), but CHF and pericarditis were significantly lower in the urokinase group (CHF, UK 5.8% vs heparin 9.9%, p=0.0004; pericarditis, UK 4.9% vs heparin 7.6%, p=0.0012). The incidence of major bleeding (UK 0.44% vs heparin 0.37%) and stroke (UK 0.35% vs heparin 0.20%) did not differ in the two groups.
No significant reduction in early mortality occurred with the addition of urokinase to anticoagulation therapy. Mortality was lower than expected in the heparin control arm (8.3% vs 13.0% in GISSI-1 and 13.2% in ISIS-2). The two treatment arms appeared equally safe in terms of stroke and major bleeding.
Am J Cardiol 1991,68:585-592.
Keywords: Infarction, Stroke, Urokinase-Type Plasminogen Activator, Chest Pain, Gentamicins, Heparin, Fibrinolytic Agents, Electrocardiography, Pericarditis, Hemorrhage, Nitroglycerin
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