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Estudio Multicentrico Estreptoquinasa Republicas de America del Sur - EMERAS
Description:
Late streptokinase thrombolysis for in-hospital mortality in suspected MI.
Hypothesis:
Patients treated between 6 and 24 hours after onset of symptoms will benefit from streptokinase.
Study Design
Study Design:
Patients Screened: 8,124
Patients Enrolled: 4,534
Mean Follow Up: 1 year
Mean Patient Age: 75: 10%
Female: 23.5
Patient Populations:
Patients presenting 6 to 24 hours after onset of MI symptoms.
Exclusions:
History of stroke, gastrointestinal hemorrhage, or stroke within last 3 months.
Severe trauma such as major surgery, head injury, or biopsy within the last 2 months.
Prolonged cardiac massage during previous 24 h.
Persistent severe hypertension, valvulopathy, or cardiomyopathy with atrial fibrillation.
Active pericarditis.
Known allergy to streptokinase, or treatment with streptokinase within last 6 months.
Pregnancy.
Severe renal or hepatic impairment.
Other life-threatening disease.
Primary Endpoints:
Mortality in hospital
Mortality at the end of the first year
Secondary Endpoints:
Stroke
MI
Other cardiovascular event
Drug/Procedures Used:
Streptokinase 1.5 MU infused intravenously over about 1 hr in 100 ml saline.
Concomitant Medications:
In original study design, aspirin was to be randomized also; however, published data on benefits of aspirin caused termination of aspirin randomization after 324 patients. Aspirin was recommended for all patients; 82% of streptokinase patients and 83% of placebo patients received aspirin.
Subcutaneous heparin: 13.9% of streptokinase patients, 14.3% of placebo patients
Intravenous heparin: 23.2% of streptokinase patients, 22.2% of placebo patients
Oral anticoagulant: 4.7% of streptokinase patients, 6.2% of placebo patients
Principal Findings:
There was no significant difference in mortality during the hospital stay (11.9% died in streptokinase group, vs 12.4% in placebo group.
Among patients presenting 7-12 hours from symptom onset, there was a non-significant trend toward fewer deaths with streptokinase (11.7% vs. 13.2%) (14% [SD 12] reduction with 95% confidence interval [CI]of 33% reduction to 12% increase).
There was little difference in mortality among patients presenting between 13 and 24 hours (11.4% vs. 10.7%); 8% [SD 16] increase with a 95% CI of 20% reduction to 45% increase.
These 95% CIs are wide and are consistent with the results of previous studies among patients presenting late after symptom onset.
Interpretation:
The EMERAS results, though not conclusive on their own, contribute substantially to accumulating evidence on the question of whether late administration of streptokinase produces any worthwhile improvement.
References:
1. Lancet 1993;342:767-72. Final results
Keywords: Thrombolytic Therapy, Hospital Mortality, Streptokinase, Coronary Disease, Length of Stay
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