Effects of Aspirin and Trapidil on Cardiovascular Events After Acute Myocardial Infarction - JAMIS

Description:

The goal of this study was to assess the safety and efficacy of antiplatelet therapy with trapidil or low-dose aspirin versus no antiplatelet therapy among patients recently diagnosed with myocardial infarction (MI).

Hypothesis:

Long-term antiplatelet therapy with trapidil or low-dose aspirin would be associated with a reduction in cardiovascular events compared to no antiplatelet therapy.

Study Design

Study Design:

Patients Enrolled: 723
Mean Follow Up: Mean 475 days
Mean Patient Age: Mean age 65
Female: 30

Patient Populations:

Patients were eligible to participate in this trial if they had an MI within the month prior to their enrollment.

Exclusions:

Exclusion criteria for this trial included: congestive heart failure, severe angina not responsive to medical therapy, serious ventricular arrhythmias, severe comorbidities, or known hypersensitivity to the study medications.

Primary Endpoints:

The primary endpoint of this study was the occurrence of cardiovascular events. These events included cardiovascular death, reinfarction, uncontrolled unstable angina, and nonfatal ischemic stroke.

Drug/Procedures Used:

Eligible patients were randomized to receive either trapidil 300 mg orally per day, aspirin 81 mg orally per day, or no antiplatelet therapy.

Concomitant Medications:

At the discretion of the attending physician, patients were also allowed to receive nitrates, calcium antagonists, beta-blockers, and angiotensin-converting enzyme inhibitors. Additionally, coronary artery angioplasty, coronary stenting, and coronary artery bypass surgery could also be authorized by the attending physician after randomization.

Principal Findings:

Patients in the trapidil group had a significant reduction in the primary endpoint of cardiovascular events (i.e., cardiovascular death, reinfarction, uncontrolled unstable angina, and nonfatal ischemic stroke) compared to no antiplatelet therapy (9.1% vs. 18.2%, p=0.0039). This difference was not significant between the aspirin and antiplatelet therapy groups (14.4% vs. 18.2%, p=0.1961).

However, there was a significant reduction in the rate of reinfarction in the aspirin group compared to the no antiplatelet therapy group (2% vs. 7.4%, p=0.0045). There was also a trend toward a reduction in the reinfarction rate in the trapidil group versus the no antiplatelet therapy group, but this did not reach statistical significance (3.7% vs. 7.4%, p=0.0810).

Interpretation:

Among patients with a recent MI, antiplatelet therapy with trapidil was associated with a reduction in the primary endpoint of cardiovascular events compared to no antiplatelet therapy, but the reduction in the rate of reinfarction was not significant. Patients who received low-dose aspirin had a significant reduction in the rate of reinfarction compared to no antiplatelet therapy, but no significant difference in the overall rate of cardiovascular events. These findings suggest that antiplatelet therapy is superior to no antiplatelet therapy in patients with a recent MI.

References:

Yasue H, Ogawa H, Tanaka H, et al. Effects of aspirin and trapidil on cardiovascular events after acute myocardial infarction. Japanese Antiplatelets Myocardial Infarction Study (JAMIS) Investigators. Am J Cardiol 1999;83:1308-13.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Statins

Keywords: Phosphodiesterase Inhibitors, Myocardial Infarction, Stroke, Platelet Aggregation Inhibitors, Ticlopidine, Angioplasty, Balloon, Coronary, Vasodilator Agents, Calcium, Nitrates, Trapidil, Coronary Vessels, Coronary Artery Bypass


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