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The safety of anistreplase from the placebo-controlled AIMS study (anistreplase Intervention Mortality Study). The
1Department of Cardiology, University of Edinburgh, Scotland.
Insights
Anisoylated plasminogen streptokinase activator complex (APSAC) showed increased hemorrhagic events and reinfarction in acute myocardial infarction patients. However, it also reduced chest pain and lowered blood pressure post-treatment.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Acute myocardial infarction (AMI) requires prompt reperfusion therapy.
- Anisoylated plasminogen streptokinase activator complex (APSAC) is a thrombolytic agent.
- Assessing APSAC's efficacy and safety in AMI is crucial.
Purpose of the Study:
- To evaluate the mortality and adverse event profile of APSAC compared to placebo in patients with acute myocardial infarction.
- To determine the safety and tolerability of APSAC in this patient population.
Main Methods:
- A parallel, double-blind, placebo-controlled mortality study.
- 1,258 patients with acute myocardial infarction were randomized.
- Patients received either APSAC or placebo, followed by anticoagulation therapy.
Main Results:
- Similar overall adverse event frequency between APSAC (80.4%) and placebo (76.0%).
- Increased hemorrhagic events (13.8% vs 4.1%) and cerebrovascular events (13 vs 5) in the APSAC group.
- Lower blood pressure, reduced chest pain, but higher in-hospital reinfarction rates in the APSAC group.
Conclusions:
- APSAC demonstrated a complex safety profile with increased bleeding and reinfarction risks.
- Despite risks, APSAC showed benefits in reducing chest pain and blood pressure.
- Further research is needed to optimize APSAC use in acute myocardial infarction management.
Abstract:
In the anistreplase, or anisoylated plasminogen streptokinase activator complex (APSAC) Intervention Mortality Study (AIMS), 1,258 patients with acute myocardial infarction were randomized in a parallel, double-blind, placebo-controlled mortality study in which they received either anistreplase or placebo, followed by anticoagulation therapy. Data on all adverse clinical events were recorded, regardless of their clinical significance or possible relation to therapy. There was a similar frequency of such events in both groups (anistreplase 80.4%, placebo 76.0%, difference not significant). Cardiovascular events included more reports of bradycardia, idioventricular rhythm, and hypotension in the anistreplase group, and a higher incidence of cardiac arrest, ventricular fibrillation, complete heart block, and pericarditis in the placebo group. Hemorrhagic events occurred in 13.8% of patients in the anistreplase group compared with 4.1% of patients in the placebo group. Most of these events consisted of bleeding or bruising around the puncture sites. There was a low incidence of allergic events after administration of both anistreplase and placebo. Thirteen cerebrovascular events (8 strokes and 5 transient ischemic episodes) were reported in the anistreplase group, compared with 5 in the placebo group (5 and 0, respectively). The mean systolic and diastolic pressures were significantly lower (by 5-10 mmHg) in patients in the anistreplase group during the first 24 hours after dosing. There were no significant differences in temperature and pulse rate between the two groups. The incidence of chest pain during the first 4- to 24-h period was lower in the anistreplase-treated patients than in the placebo group. The frequency of in-hospital reinfarction was higher in anistreplase-treated patients compared with patients given placebo.(ABSTRACT TRUNCATED AT 250 WORDS)
