APSAC Intervention Mortality Study - AIMS

Description:

Anistreplase (APSAC) for 1-year mortality in acute myocardial infarction.

Hypothesis:

A single dose of anistreplase, given within 6 h of onset of AMI, would reduce mortality compared to placebo.

Study Design

Study Design:

Patients Screened: 0
Patients Enrolled: 1,258
Mean Follow Up: 1 year
Mean Patient Age: 60: 40%
Female: 18

Patient Populations:

Age <70 years
Major symptoms suggestive of AMI lasting for at least 30 min
Treatment possible within 6 h of onset of symptoms

Exclusions:

Bleeding risks
Cardiovascular contraindications
Recent thrombolysis

Primary Endpoints:

Death

Secondary Endpoints:

Cardiogenic shock
Cardiac arrest
Cardiac rupture
Ventricular septal defect
Ventricular fibrillation
Ventricular tachycardia
Unspecified ventricular arrhythmias
Bradycardia
Reinfarction
Bleeding
Falls in systolic and diastolic blood pressure
Cerebrovascular events
Anaphylactic and other allergic reactions

Drug/Procedures Used:

Intravenous anisoylated plasminogen streptokinase activator complex (anistreplase), 30 units in a single injection over 5 min.

Concomitant Medications:

Intravenous heparin 6 h after administration of anistreplase or placebo
Anticoagulants
Vasodilators
β-blockers
Diuretics
Aspirin

Principal Findings:

At 30 days, 6% (40/624) of patients in the anistreplase group had died compared to 12% (77/634) in the placebo group (odds reduction 50.5%).

At 1 year, the mortality rates were 11% and 18%, respectively (odds reduction 43%; p=0.0007; 95% CI, 21% to 59%). Major cardiovascular complications were less frequent with anistreplase treatment (77 vs. 106; p=0.03).

Interpretation:

These findings were encouraging for anistreplase (APSAC) as an effective and acceptably safe thrombolytic with long-term survival benefits for patients with AMI. Enrollment was terminated early due to the observed reduction in 30-day mortality. A subsequent analysis by Fox (Am J Cardiol 1991;67:38E-44E) attempted an indirect comparison between APSAC, t-PA, and streptokinase. The randomized ISIS-3 subsequently showed no efficacy difference among the thrombolytics.

References:

1. Lancet 1988; i: 545-549.
2. Lancet 1990; 335:427-431.

Clinical Topics: Dyslipidemia, Lipid Metabolism, Novel Agents

Keywords: Myocardial Infarction, Streptokinase, Fibrinolysis, Anistreplase, Fibrinolytic Agents, Tissue Plasminogen Activator


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