Lyon Heart Study - Lyon Heart Study

Description:

The Lyon Diet Heart Study is a randomized secondary prevention trial aimed at testing whether a Mediterranean-type diet is associated with a reduced risk of recurrent myocardial infarction after a first myocardial infarction

Hypothesis:

A diet rich in alpha-linolenic acids (Mediterranean diet) may reduce cardiovascular events in a high-risk population

Study Design

Study Design:

Patients Enrolled: 605
Mean Follow Up: 46 months mean

Primary Endpoints:

Cardiac death Nonfatal myocardial infarction

Secondary Endpoints:

Major secondary endpoints: unstable angina, stroke, heart failure, pulmonary or peripheral embolism Minor secondary endpoints: recurrent stable angina, postangioplasty restenosis, surgical or medical myocardial revascularization, and thrombophlebitis

Drug/Procedures Used:

Post-infarct patients were randomized to a traditional Western-style diet versus a Mediterranean alpha-linolenic acid-rich diet

Principal Findings:

There were 3 composite endpoints (CEs): Composite Endpoint 1: Cardiac death and nonfatal myocardial infarction Composite endpoint 2: CE1 + major secondary end points (unstable angina, stroke, heart failure, pulmonary or peripheral embolism) Composited endpoint 3: CE2 + minor events requiring hospital admission (recurrent stable angina, postangioplasty restenosis, surgical or medical myocardial revascularization, and thrombophlebitis) In the Mediterranean diet group, composite endpoin 1 (death/MI) was reduced (14 events versus 44 in the prudent Western-type diet group, P=0.0001), as was CE2 (27 events versus 90, P=0.0001) and CE3 (95 events versus 180, P=0.0002). Adjusted risk ratios ranged from 0.28 to 0.53. Among the traditional risk factors, total cholesterol (1 mmol/L being associated with an increased risk of 18% to 28%), systolic blood pressure (1 mm Hg being associated with an increased risk of 1% to 2%), leukocyte count (adjusted risk ratios ranging from 1.64 to 2.86 with count >9x109/L), female sex (adjusted risk ratios, 0.27 to 0.46), and aspirin use (adjusted risk ratios, 0.59 to 0.82) were each significantly and independently associated with recurrence.

Interpretation:

The Mediterranean dietary pattern was associated with an event reduction for up to 4 years after the first infarction. Major traditional risk factors, such as high blood cholesterol and blood pressure, were shown to be independent and joint predictors of recurrence, indicating that the Mediterranean dietary pattern did not alter, at least qualitatively, the usual relationships between major risk factors and recurrence. Thus, a comprehensive strategy to decrease cardiovascular morbidity and mortality should include primarily a cardioprotective diet. It should be associated with other (pharmacological?) means aimed at reducing modifiable risk factors. Further trials combining the 2 approaches are warranted.

References:

Circulation, 2001;103:1823-1825 Circulation, 1999;99:779-785 Lancet, 1994;343:1454–1459

Keywords: alpha-Linolenic Acid, Odds Ratio, Myocardial Infarction, Stroke, Angina, Stable, Leukocyte Count, Blood Pressure, Risk Factors, Diet, Mediterranean, Cholesterol, Thrombophlebitis, Secondary Prevention, Myocardial Revascularization, Heart Failure, Embolism


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