Urochinasi per via Sistemica nell'Infarto Miocardico - USIM

May 09, 2002
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Date Published:
01/01/1991
Date Updated:
05/09/2002
Original Posted Date:
05/09/2002
References

Description:

A randomized trial of the effect of IV urokinase plus heparin vs heparin alone on early mortality.

Hypothesis:

Early mortality would be reduced from 12% in the control group to 10% in the urokinase group.

Study Design

Study Design:

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
Female: 18

Patient Populations:

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

Primary Endpoints:

In-hospital mortality

Secondary Endpoints:

Bleeding complications Nonfatal cardiac events (recurrent MI, CHF)

Drug/Procedures Used:

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.

Principal Findings:

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.

Interpretation:

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.

References:

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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