The PANDORA study: peripheral arterial disease in patients with non-high cardiovascular risk
Few studies are available with sufficient sample size to accurately describe the prevalence of low ankle-brachial index (ABI) in patients at ‘non-high’ cardiovascular (CV) risk. The aim of this study was to evaluate the prevalence of asymptomatic peripheral arterial disease (PAD), as determined by using ABI, in this patient population. A non-interventional, cross-sectional, pan-European study was conducted in patients with ≥1 CV risk factor in addition to age, evaluating the prevalence of asymptomatic PAD (ABI ≤ 0.90). Secondary objectives included assessing the prevalence and treatment of CV risk factors. Patients were consecutively recruited during scheduled visits to the physician’s office, or were randomly selected by the physician from a list of eligible patients. Patients with diabetes were excluded as this condition was deemed to be a secondary prevention risk. 10,287 patients were enrolled (9,816 evaluable: mean age 64.3 years; 53.5% male). Prevalence of asymptomatic PAD was 17.8% (99% CI 16.84–18.83). Factors significantly associated with asymptomatic PAD included hypertension, age, alcohol intake, family history of coronary heart disease, low levels of high-density lipoprotein-cholesterol, and smoking (p < 0.0001). Patients treated with statins were significantly less likely to have asymptomatic PAD than those who were not (odds ratio 0.62; 95% CI 0.50–0.76; p < 0.0001). Asymptomatic PAD was highly prevalent in patients with non-high CV risk, the majority of whom would not typically be candidates for ABI assessment. These patients should be carefully screened, and ABI measured, so that therapeutic interventions known to diminish their increased CV risk may be offered.
KeywordsAnkle-brachial index Atherosclerosis Peripheral vascular disease Prevention Risk factors
This study was funded by AstraZeneca. The authors thank Jennifer Stewart, MSc, from QXV Communications, Macclesfield, UK, for her assistance in the manuscript preparation which was funded by AstraZeneca.
Conflict of interest
The authors of this paper have full control of all primary data and, if requested, agree that Internal and Emergency Medicine can review the data.
Prof C Cimminiello has acted as a speaker and chairman at scientific meetings sponsored by AstraZeneca, Sanofi-Aventis and Bristol-Myers-Squibb. Prof C Borghi has acted as a consultant or speaker on occasions for Recordati, AstraZeneca, Merck, MSD, Novartis, Boehringer Ingelheim, Takeda, and Schering-Plough and has received research funding from Boehringer Ingelheim, Sanofi-Aventis, Takeda, Italian Society of Hypertension, and Regional Drug Agency; he does not have any conflict of interest regarding the present activity. Dr S Kownator has been occasional consultant or speaker for AstraZeneca, Bristol-Myers-Squibb, Daichi-Sankyo, MSD, Novartis, Pfizer, Sanofi-Aventis, Schering-Plough, Solvay. Prof JC Wautrecht has no conflict of interests. Prof CP Carvounis has received grants and acted as a consultant for AstraZeneca. Dr S.E. Kranendonk has acted as occasional speaker and is national study coordinator in the Netherlands. Dr B Kindler participated as investigator in AstraZeneca-sponsored clinical trial. Dr M Mangrella is an employee of AstraZeneca.
- 8.Hirsch AT, Haskal ZJ, Hertzer NR et al (2006) ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation 113:e463–e654PubMedCrossRefGoogle Scholar
- 10.Graham I, Atar D, Borch-Johnsen K et al (2007) European guidelines on cardiovascular disease prevention in clinical practice: full text. Fourth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts). Eur J Cardiovasc Prev Rehabil 14(Suppl 2):S1–S113PubMedCrossRefGoogle Scholar
- 18.Grundy SM, Pasternak R, Greenland P, Smith S Jr, Fuster V (1999) Assessment of cardiovascular risk by use of multiple-risk-factor assessment equations: a statement for healthcare professionals from the American Heart Association and the American College of Cardiology. Circulation 100:1481–1492PubMedGoogle Scholar
- 27.Dhangana R, Murphy TP, Pencina MJ, Ristuccia MB, Cereo JV, Tsai D (2009) Prevalence of low ankle-brachial index, elevated plasma fibrinogen and CRP among those otherwise at low-intermediate cardiovascular events’ risk: data from the National Health and Nutrition Examination Study (NHANES) 1999–2004. J Vasc Interv Radiol 20(suppl 2):S57CrossRefGoogle Scholar
- 28.Zimmerman BR, Palumbo PJ, Fallon WM, Ellefson RD, Osmundson PJ, Kazmier FJ (1981) A prospective study of peripheral occlusive arterial disease in diabetes, III: initial lipid and lipoprotein findings. Mayo Clinic Proc 56:233–242Google Scholar
- 30.Heart Protection Study Collaborative Group (2007) Randomized trial of the effects of cholesterol-lowering with simvastatin on peripheral vascular and other major vascular outcomes in 20,536 people with peripheral arterial disease and other high-risk conditions. J Vasc Surg 45:645–654CrossRefGoogle Scholar
- 34.Rosengren A, Hawken S, Ounpuu S, for the INTERHEART investigators et al (2004) Association of psychosocial risk factors with risk of acute myocardial infarction in 11 119 cases and 13 648 controls from 52 countries (the INTERHEART study): case-control study. Lancet 364:953–962PubMedCrossRefGoogle Scholar