Thrombolysis In Myocardial Ischemia trial, phase 9B - TIMI 9B

Description:

Heparin vs. hirudin for 30-day death or reinfarction in acute MI.

Hypothesis:

To compare the safety and efficacy of heparin vs hirudin in acute myocardial infarction

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 3,002
Mean Follow Up: 30 days
Mean Patient Age: 60
Female: 25

Patient Populations:

Episode of ischemic discomfort lasting at least 30 min within 12 hours.
ECG with > 0.1 mV ST elevation in at least 2 leads or new left bundle branch block.

Exclusions:

Contraindications to thrombolytic therapy
Blood pressure >190/110
Serum creatinine > 2.0 mg/dl
Age < 21 years
Cardiogenic shock
Women of child-bearing potential
Therapeutic anticoagulation

Primary Endpoints:

Death, nonfatal MI, cardiogenic shock at 30 days
Major hemorrhage (overt bleeding with absolute decrease in hematocrit > 15% or decrease in hemoglobin > 5mg/dl, or any intracranial or retriperitoneal bleed) or severe anaphylaxis.

Drug/Procedures Used:

Hirudin, 0.1 mg/kg bolus (maximum 15mg) followed by infusion of 0.1 mg/kg/hr (max 15 mg/hr) for 96 hours; vs heparin, 5000 unit bolus followed by infusion at 1000 units/hr for 96 hours.

Concomitant Medications:

Aspirin, thrombolysis with alteplase or streptokinase

Principal Findings:

A total of 1,491 patients were randomized to heparin and 1511 patients were randomized to hirudin.

The primary end point was similar in the hirudin group (11.9%) compared to the heparin group (12.9%)

The rate of major hemorrhage was similar in the heparin (5.3%) and hirudin (4.6%) groups; intracranial hemorrhage occurred in 0.9% of the heparin and 0.4% of the hirudin patients.

Subgroup analyses did not reveal any profile of patients who benefited more from one of the antithrombins.

Interpretation:

Heparin and hirudin have an equal effect as adjunctive therapy to tPA and streptokinase in preventing unsatisfactory outcome in patients with acute myocardial infarction. Similar rates of major bleeding were observed for patients in the heparin and hirudin groups.

References:

1. Circulation 1996;94:911-21. Final results

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Dyslipidemia, EP Basic Science, Lipid Metabolism

Keywords: Myocardial Infarction, Intracranial Hemorrhages, Streptokinase, Heparin, Bundle-Branch Block, Electrocardiography, Tissue Plasminogen Activator, Hirudins


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