Association of Mediterranean Diet With Peripheral Artery Disease: The PREDIMED Randomized Trial

Study Questions:

Is a Mediterranean dietary pattern associated with lower risk for peripheral arterial disease (PAD)?


Data from the PREDIMED (Prevención con Dieta Mediterránea) study, a multicenter, randomized, primary prevention feeding trial conducted in Spain, were used for the present analysis. Participants were men ages 55-80 years and women ages 60-80 years without clinical PAD or baseline cardiovascular disease, but with type 2 diabetes mellitus or at least three cardiovascular risk factors, enrolled between October 2003 and December 2010. Participants were randomized to one of three groups: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with nuts, or counseling on a low-fat diet (control group). Incident symptomatic PAD events were confirmed by a blinded, central endpoint adjudication committee. A confirmed diagnosis of PAD in symptomatic patients required at least one of the following criteria: an ankle-brachial index of <0.9 at rest, a clinical diagnosis of arterial occlusive disease based on imaging tests (duplex ultrasonography, magnetic resonance angiography, computed tomographic angiography, or catheter-based angiography), or an endovascular or open surgical procedure (revascularization or amputation).


Out of a total of 8,713 eligible candidates, 7,477 were initially included and randomized in the PREDIMED trial. From these, 12 participants were excluded for intermittent claudication symptoms at baseline. The mean (standard deviation) age of included participants was 67 (6.2) years, and 58% were women. During a median follow-up of 4.8 years, 89 confirmed incident cases of PAD were identified. Both Mediterranean diet interventions were associated with a lower risk of PAD compared with the control group. After adjustment for atherosclerotic risk factors, the hazard ratio (HR) was 0.34 (95% confidence interval [CI], 0.20-0.58) for participants in the Mediterranean diet plus extra-virgin olive oil group and 0.50 (95% CI, 0.30-0.81) for the Mediterranean diet plus nuts group versus control group. No statistically significant difference between the two active intervention groups was observed. The number needed to treat to prevent one case of PAD per year was 336 (95% CI, 269-566) for the Mediterranean diet plus extra-virgin olive oil group and 448 (95% CI, 316-1536) for the Mediterranean diet plus nuts group.


The investigators concluded that a Mediterranean diet is associated with reduced risk for PAD. However, this was an exploratory analysis, as PAD was not a prespecified endpoint.


These data suggest the need for a larger randomized controlled trial of diet to reduce PAD.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Lipid Metabolism, Diet

Keywords: Intermittent Claudication, Food Habits, Ankle Brachial Index, Diabetes Mellitus, Type 2, Peripheral Arterial Disease, Diet, Mediterranean, Peripheral Vascular Diseases, Metabolic Syndrome X, Plant Oils, Spain, Cardiovascular Diseases, Nuts, Diet, Fat-Restricted, Confidence Intervals

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