Methods:

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).