Double-Blind Trial of Aspirin in Primary Prevention of Myocardial Infarction in Patients With Stable Chronic Angina Pectoris - SAPAT

Description:

This was a prospective, double-blind, randomized trial of low-dose aspirin as primary prevention for myocardial infarction (MI) among patients with chronic angina.

Hypothesis:

The addition of low-dose aspirin to sotalol may be associated with a decreased incidence of MI.

Study Design

Study Design:

Patients Enrolled: 2,035
Mean Follow Up: 50 months
Mean Patient Age: Mean of 67
Female: 48

Patient Populations:

History of exertional chest pain for at least one month and age 30-80

Exclusions:

  • Patients already on aspirin, anticoagulants, verapamil, or nonsteroidal anti-inflammatory drug
  • Patients on more than hydrochlorothiazide 50 mg, bendroflumethiazide 5 mg, or furosemide 40 mg
  • Treatment with class I antiarrhythmic
  • Heart rate <55 per minute
  • History of MI
  • Type II or III AV block
  • Symptoms of obstructive lung disease
  • Active peptic ulcer disease
  • Hypersensitivity to aspirin
  • Juvenile diabetes
  • Uncontrolled late-onset diabetes

Primary Endpoints:

First occurrence of nonfatal, in-hospital MI, or sudden death

Secondary Endpoints:

Vascular events (first occurrence of MI, stroke, or vascular death), vascular death, all-cause mortality, or stroke

Drug/Procedures Used:

Patients were randomized to aspirin 75 mg daily (n=1,009) or placebo (n=1,026)

Concomitant Medications:

Sotalol at mean dose of 160 mg daily

Principal Findings:

  • Addition of aspirin 75 mg daily was associated with 34% reduction in primary outcome of MI or sudden death (8% vs. 12%, p=0.003).
  • Addition of aspirin was associated with a 32% reduction in vascular events compared with placebo (10.7% vs. 15.7%, p<0.001).
  • There was no significant difference in the incidence of major bleeding.

Interpretation:

Among patients with chronic angina, the addition of low-dose aspirin in addition to sotalol was associated with a significant reduction in MI and death without an increase in major bleeding compared with sotalol alone.

References:

Juul-Moller S, Edvardsson N, Jahnmatz B, Rosen A, Sorensen S, Omblus R. Double-blind trial of aspirin in primary prevention of myocardial infarction in patients with stable chronic angina pectoris. The Swedish Angina Pectoris Aspirin Trial (SAPAT) Group. Lancet 1992;340:1421-5.

Clinical Topics: Prevention

Keywords: Myocardial Infarction, Platelet Aggregation Inhibitors, Death, Sudden, Coronary Disease, Sotalol, Hemorrhage, Primary Prevention


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