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Sibrafiban versus Aspirin to Yield Maximum Protection from Ischemic Heart Events Post-acute Coronary Syndromes - SYMPHONY I
Description:
Not available.
Hypothesis:
To compare the efficacy, safety and tolerability of long-term sibrafiban with aspirin following an episode of acute coronary syndrome, i.e., Q-wave and non-Q wave myocardial infarction, and unstable angina.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 9233
Mean Follow Up: 90 days
Patient Populations:
Patients who have presented with an acute coronary syndome.
Exclusions:
Serious illness, predispositon to bleeding, major surgery, previous stroke or intracranial hemorrhage, etc.
Primary Endpoints:
Composite of of all-cause mortality, non-fatal myocardial infarction, or severe recurrent ischemia.
Drug/Procedures Used:
1. Aspirin 80 mg every 12 hours for a minimum of 12 months
2. High dose oral sibrafiban (6, 4.5 or 3 mg depending on creatinine and body weight) every 12 hours for 12 months
3. Low dose sibrafiban (4.5 or 3 mg, depending on creatinine and body wei
Principal Findings:
Premature discontinuation of the study drug occurred in 19.2% in the aspirin group, 22.3% in the low dose sibrafiban group and 23.8% in the high dose sibrafiban group. The primary endpoint of the study (death, myocardial [re]infarction, or severe recurrent ischemia at 90 days) occurred in 9.8% in the aspirin group, 10.1% in the low dose sibrafiban group and 10.1% in the high dose sibrafiban group (odds ratio for aspirin vs both the low and high dose sibrafiban 1.03;95% CI 0.87-1.21). Death or myocardial (re)infarction occurred in 7.0%, 7.4% and 7.9%, respectively. There were no differences among the three groups concerning the predefined secondary endpoints of either all cause mortality, myocardial (re)infarction, severe recurrent ischemia, readmission, reversible coronary ischemia, or any revascularization. Large myocardial infarctions (CKMB >X5 the upper limit of normal) occurred less often in the aspirin group (37.4%) than in the low (45.3%) or high dose (49.7%) sibrafiban groups. Treatment effects were comparable among the various subgroups. Bleedings occurred in 13.0% of the aspirin group vs 18.7% and 25.4% in the low and high dose sibrafiban groups. Major bleedings occurred in 3.9%, 5.2% and 5.7%, respectively. Thrombocytopenia was infrequent and did not differ among the treatment groups.
Interpretation:
Sibrafiban had no advantage over aspirin for prevention of major ischemic events in stable patients after an acute coronary syndrome and was associated with higher bleeding rates than aspirin.
References:
Lancet 2000;355:337-45. Am Heart J 1999;138:210-18.
Keywords: Odds Ratio, Myocardial Infarction, Acute Coronary Syndrome, Oximes, Piperidines, Platelet Aggregation Inhibitors, Body Weight, Creatinine, Thrombocytopenia
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