Study Design

Study Design:

Patients Enrolled: 370
Mean Follow Up: Hospital Discharge
Mean Patient Age: <76
Female: 22

Patient Populations:

Age <76 years, symptoms of chest pain for more than 30 minutes but less than four hours prior to treatment, ST-segment elevation of 0.1 mV or more in one or more limb leads or 0.2 mV or more in one or more precordial leads, and symptoms not relieved by nitroglycerine

Exclusions:

Cardiogenic shock, history of CABG or PTCA within one month, contraindication to thrombolytic therapy including recent (<6 months) history of thrombotic cerebrovascular accident (CVA) or intracranial or intraspinal surgery, hemorrhagic CVA at any time, active internal bleeding, history of hemorrhagic diathesis, peptic ulcer within six months, long-term full dose anticoagulation with warfarin or Coumadin, external chest massage or other injury for this episode of infarction, other major trauma within 10 days, pregnancy or lactation or childbearing potential, prosthetic heart valves, dilated cardiomyopathy, ventricular aneurysm with thrombus, streptokinase or antistreplase within previous six months, other investigational drug therapy within two months, systolic blood pressure >200 mm Hg, or diastolic blood pressure >120 mm Hg

Primary Endpoints:

Infarct-related vessel patency defined as TIMI 2 or 3 flow at early (90-240 minutes) and late (24 hours) angiography

Secondary Endpoints:

Rates of angioplasty and CABG; adverse events including hypotension, mortality, bleeding complications, and stroke; and residual percent stenosis in the infarct-related vessel and rates of individual TIMI grade flows

Drug/Procedures Used:

Patients were randomized to IV infusion of streptokinase (1.5 million U over 60 minutes) or antistreplase (30 U over 2-5 minutes). Coronary perfusion status was determined early (between 90 minutes and 240 minutes after start of therapy) and late (24 hours) via coronary angiography. For patients with TIMI grade 0, 1, or poor grade 2 flow through the infarct-related vessel, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) was allowed before the 24-hour angiogram at the discretion of the treating physician.

Concomitant Medications:

All patients received heparin (5000-10,000 U bolus at the start of catheterization titrated as continuous infusion to activated partial thromboplastin time twice the upper limit of normal) and continued for at least 24 hours.

Before hospitalization, other therapies for the antistreplase and streptokinase arms, respectively, included nitrates (15% vs. 12%) and beta-blockers (13% vs. 14%). After hospitalization but before thrombolysis, other therapies for the antistreplase and streptokinase arms, respectively, included nitrates (89% vs. 92%) and beta-blockers (4% vs. 5%).

Aspirin use was not reported. Diphenhydramine was recommended, but not required prior to thrombolysis.