European Cooperative Study Group for Recombinant Tissue-Type Plasminogen Activator - ECSG-1

Description:

Streptokinase vs. alteplase for coronary patency in acute MI.

Hypothesis:

Heparin plus rt-PA is more effective than heparin plus streptokinase on the patency of infarct-related vessels in patients after AMI.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 129
Mean Follow Up: Duration of hospital stay after AMI
Mean Patient Age: 54.7
Female: 18

Patient Populations:

Age > 21 and < 70 years.
Without previous MI.
Severe chest pain typical of MI ischemia persisted for > 30 minutes.
> 2 mm ST-segment elevation (60 ms after J point) in 2 or more standard frontal plane leads, or > 3mm in 2 or more precordial leads.
Treatment could be started within 6 hours of the onset of major symptoms.

Exclusions:

Hypotension (systolic pressure < 90 mm Hg).
Heart rate over 110 bpm in a clinical setting typical of cardiogenic shock.
History of previous infarction or cerebrovascular accident.
Major surgery during previous 6 months, or gastrointestinal bleeding in previous 3 months.
Severe hypertension (systolic pressure > 200 mm Hg).
Prolonged or traumatic heart massage or artificial respiration.
Oral anticoagulation, a known bleeding disorder, or recent major trauma, particularly head injury.
Major hepatic or renal disease, cancer, or proliferative diabetic retinopathy.
Known alcohol or drug abuse.
Pregnancy or actual menstruation.
Anticipated problems with heart catheterization, inability to cooperate, or anticipated problems with follow-up.
Previous coronary or non-coronary heart surgery.

Primary Endpoints:

Hospital mortality
Patency of infarct-related coronary arteries
Bleeding complications
Cardiovascular complications: chest pain, reinfarction, decrease in systolic pressure, cardiogenic shock, atrial or ventricular fibrillation, CVA, or pulmonary embolism

Secondary Endpoints:

Peak plasma levels
Plasma fibrinogen level
Fibrinogen degradation products in serum

Drug/Procedures Used:

Heparin 5,000 IU plus human rt-PA, 0.75 mg/kg body weight over 90 minutes.
Heparin 5,000 IU plus streptokinase, 1,500,000 IU over 60 minutes.

Concomitant Medications:

No antiarrhythmic drugs were given prophylactically, but they were used as required.
Analgesics were given ad libitum.

Principal Findings:

In rt-PA patients, the infarct-related coronary artery was patent in 70% of angiograms taken 75-90 minutes after start of infusion, compared with 55% for streptokinase patients. The 95% confidence interval (CI) of the difference ranges from +/- 30 to -2% (p=0.054).

Bleeding episodes and other complications were less common in rt-PA patients than in the streptokinase group.

Hospital mortality was identical in the 2 groups.

Activation of the systemic fibrinolytic system was far less pronounced with rt-PA than with streptokinase.

Interpretation:

Heparin plus rt-PA is more effective than heparin plus streptokinase on the patency of infarct-related vessels in patients after AMI.

References:

1. Lancet 1985;I(8433):842-847. Final results

Keywords: Hospital Mortality, Streptokinase, Chest Pain, Body Weight, Heparin, Coronary Disease, Coronary Vessels, Tissue Plasminogen Activator


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