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Double-Blind Multicenter Comparison of the Efficacy and Safety of Saruplase and Urokinase in the Treatment of Acute Myocardial Infarction: Report of the SUTAMI Study Group - SUTAMI
Description:
SUTAMI was a prospective, randomized, double-blind, multicenter study of the efficacy of saruplase (recombinant unglycosylated single-chain urokinase-type plasminogen activator, the partent molecule of urokinase) versus urokinase in patients with acute ST elevation myocardial infarction.
Hypothesis:
Saruplase will be as effective and safe as urokinase for the thrombolytic treatment of ST-segment elevation myocardial infarction.
Study Design
Study Design:
Patients Enrolled: 543
Mean Follow Up: One year
Mean Patient Age: 20-75
Female: ~18
Patient Populations:
Patients with typical chest pain for at least 30 minutes, ST-segment elevation of at least 0.3 mV in two or more precordial leads, or ST-segment elevation of at least 2 mV in two or more frontal plane leads; start of therapy within six hours of chest pain onset; and age 20-75 years
Exclusions:
Any generally accepted contraindication to thrombolytic therapy (specific criteria referenced but not reported)
Primary Endpoints:
Patency of the infarct-related vessel at 24 and 72 hours after start of therapy
Secondary Endpoints:
1) Incidence of bleeding complications. Severe bleeding was defined as bleeding that required active measures such as aprotinin, surgery, or transfusion.
2) Levels of hemostatic parameters such as fibrinogen, plasminogen, alpha2-antiplasmin, and fibrin degradation products.
3) Mortality and re-infarction at one year.
Drug/Procedures Used:
Patients with acute ST-segment elevation myocardial infarction were randomized to either saruplase, 20 mg/20 ml given over two minutes followed by 60 mg over one hour, or urokinase, 1.5 million IU over one hour. All patients received nitroglycerin unless contraindicated. Heparin was administered 30 minutes after the end of thrombolytic therapy and titrated to an activated partial thromboplastin time of 1.5-2.5 times control. All patients underwent angiography at 24-72 hours after start of therapy.
Principal Findings:
Five hundred and forty three patients were enrolled from July 1988 through February 1990. The saruplase and urokinase arms were well matched at baseline in terms of age, sex, height, weight, blood pressure, and time from symptom onset to start of infusion.
There were slightly more anterior infarcts in the urokinase group (40.4% vs. 50.2%, p=0.02) and baseline pulse was slightly higher for the urokinase group (76.1 vs. 72.3, p<0.01). At 24-72 hours after start of therapy, the patency rates were similar for the two arms (75.4% for saruplase vs. 74.2% for urokinase, p=0.77).
The incidence of total bleeding complications in both groups was 10.7%. Severe bleeding occurred in nine cases with saruplase and seven cases with urokinase. There were three hemorrhagic strokes in the saruplase group and none in the urokinase group. At one year, 20 patients in the saruplase arm and 31 patients in the urokinase arm had died (p=0.1). The one year re-infarction rate was 6.3% for saruplase and 7.1% for urokinase (p>0.5).
Blood levels of fibrin degradation products rose more with saruplase than with urokinase. All other hemostatic parameters (fibrinogen, alpha2-antiplasmin, and plasminogen levels) were similar between groups.
Interpretation:
Among patients with acute ST-segment elevation myocardial infarction, saruplase was associated with similar vessel patency rates at 24-72 hours compared to urokinase with similar rates of bleeding complications.
References:
Michels R, Hoffman H, Windeler J, Barth H, Hopkins G. A Double-blind Multicenter Comparison of the Efficacy and Safety of Saruplase and Urokinase in the Treatment of Acute Myocardial Infarction: Report of the SUTAMI Study Group. J Thromb Thrombolysis 1995;2:117-24.
Keywords: Thrombolytic Therapy, Myocardial Infarction, Stroke, Urokinase-Type Plasminogen Activator, Heparin, Blood Pressure, Fibrinolytic Agents, Fibrin Fibrinogen Degradation Products, Chest Pain, Plasminogen, Partial Thromboplastin Time, Recombinant Proteins, Fibrinogen, Hemorrhage, Nitroglycerin
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