Internal and Emergency Medicine

, Volume 6, Issue 6, pp 509–519

The PANDORA study: peripheral arterial disease in patients with non-high cardiovascular risk

  • Claudio Cimminiello
  • Serge Kownator
  • Jean-Claude Wautrecht
  • Christos P. Carvounis
  • Stefanus Eliza Kranendonk
  • Beat Kindler
  • Mario Mangrella
  • Claudio Borghi
  • for the PANDORA Study Investigators
IM - Original

Abstract

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.

Keywords

Ankle-brachial index Atherosclerosis Peripheral vascular disease Prevention Risk factors 

References

  1. 1.
    Kannel WB, Skinner JJ Jr, Schwartz MJ, Shurtleff D (1970) Intermittent claudication: incidence in the Framingham Study. Circulation 41:875–883PubMedGoogle Scholar
  2. 2.
    Stoffers HEJH, Kester ADM, Kaiser V, Rinkens PELM, Kitslaar PJEHM, Knottnerus AJ (1996) The diagnostic value of the measurement of the ankle–brachial systolic pressure index in primary health care. J Clin Epidemiol 49:1401–1405PubMedCrossRefGoogle Scholar
  3. 3.
    Reunanen A, Takkunen H, Aromaa A (1982) Prevalence of intermittent claudication and its effect on mortality. Acta Med Scand 211:249–256PubMedCrossRefGoogle Scholar
  4. 4.
    Hughson WG, Mann JI, Tibbs DJ, Woods HF, Walton I (1978) Intermittent claudication: factors determining outcome. Br Med J 1:1377–1379PubMedCrossRefGoogle Scholar
  5. 5.
    Leng GC, Lee AJ, Fowkes FGR et al (1996) Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. Int J Epidemiol 25:1172–1181PubMedCrossRefGoogle Scholar
  6. 6.
    Hooi JD, Kester AD, Stoffers HE, Rinkens PE, Knottnerus JA, van Ree JW (2004) Asymptomatic peripheral arterial occlusive disease predicted cardiovascular morbidity and mortality in a 7-year follow-up study. J Clin Epidemiol 57:294–300PubMedCrossRefGoogle Scholar
  7. 7.
    Criqui MH, Langer RD, Fronek A et al (1992) Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med 326:381–386PubMedCrossRefGoogle Scholar
  8. 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
  9. 9.
    Norgren L, Hiatt WR, Dormandy JA et al (2007) TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease. Int Angiol 26:81–157PubMedGoogle Scholar
  10. 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
  11. 11.
    Fowkes FG, Murray GD, Butcher I, for the Ankle Brachial Index Collaboration et al (2008) Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis. JAMA 300:197–208PubMedCrossRefGoogle Scholar
  12. 12.
    Beckman JA, Jaff MR, Creager MA (2006) The United States Preventive Services Task Force Recommendation Statement on screening for peripheral arterial disease: more harm than benefit? Circulation 114:861–866PubMedCrossRefGoogle Scholar
  13. 13.
    Diehm C, Allenberg JR, Pittrow D, for the German Epidemiological Trial on Ankle Brachial Index Study Group et al (2009) Mortality and vascular morbidity in older adults with asymptomatic versus symptomatic peripheral artery disease. Circulation 120:2053–2061PubMedCrossRefGoogle Scholar
  14. 14.
    Grundy SM, Cleeman JI, Merz CN et al (2004) Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 110:227–239PubMedCrossRefGoogle Scholar
  15. 15.
    Cimminiello C, Borghi C, Kownator S et al (2010) Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study. BMC Cardiovasc Disord 10:35–40PubMedCrossRefGoogle Scholar
  16. 16.
    Hiatt WR, Goldstone J, Smithe SC et al (2008) Atherosclerotic peripheral vascular disease symposium II: nomenclature for vascular diseases. Circulation 118:2826–2829PubMedCrossRefGoogle Scholar
  17. 17.
    Wilson PW, Castelli WP, Kannel WB (1987) Coronary risk prediction in adults (the Framingham Heart Study). Am J Cardiol 59:91G–94GPubMedCrossRefGoogle Scholar
  18. 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
  19. 19.
    Conroy RM, Pyörälä K, Fitzgerald AP et al (2003) Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. SCORE project group. Eur Heart J 11:987–1003CrossRefGoogle Scholar
  20. 20.
    Fowkes FGR, Low LP, Tuta S, Kozak J, on behalf of the AGATHA Investigators (2006) Ankle-brachial index and extent of atherothrombosis in 8891 subjects with or at risk of vascular disease: results of the international AGATHA study. Eur Heart J 27:1861–1867PubMedCrossRefGoogle Scholar
  21. 21.
    Hirsch AT, Criqui MH, Treat-Jacobson D et al (2001) Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA 286:1317–1324PubMedCrossRefGoogle Scholar
  22. 22.
    McDermott MM, Guralnik JM, Tian L et al (2009) Associations of borderline and low normal ankle-brachial index values with functional decline at 5-year follow-up: the WALCS (Walking and Leg Circulation Study). J Am Coll Cardiol 53:1056–1062PubMedCrossRefGoogle Scholar
  23. 23.
    Resnick HE, Lindsay RS, McDermott MM et al (2004) Relationship of high and low ankle brachial index to all-cause and cardiovascular disease mortality: the Strong Heart Study. Circulation 109:733–739PubMedCrossRefGoogle Scholar
  24. 24.
    O’Hare AM, Katz R, Shlipak MG, Cushman M, Newman AB (2006) Mortality and cardiovascular risk across the ankle-arm index spectrum: results from the Cardiovascular Health Study. Circulation 113:388–393PubMedCrossRefGoogle Scholar
  25. 25.
    getABI Study Group (2002) German epidemiological trial on ankle brachial index for elderly patients in family practice to detect peripheral arterial disease, significant marker for high mortality. Vasa 31:241–248CrossRefGoogle Scholar
  26. 26.
    Diehm C, Schuster A, Allenberg JR et al (2004) High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis 172:95–105PubMedCrossRefGoogle Scholar
  27. 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. 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
  29. 29.
    Murabito JM, D’Agostino RB, Silbershatz H et al (1997) Intermittent claudication. A risk profile from the Framingham Heart Study. Circulation 96:44–49PubMedGoogle Scholar
  30. 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
  31. 31.
    Pedersen TR, Kjekshus J, Pyörälä K et al (1998) Effect of simvastatin on ischemic signs and symptoms in the Scandinavian simvastatin survival study (4S). Am J Cardiol 81:333–335PubMedCrossRefGoogle Scholar
  32. 32.
    Giri J, McDermott MM, Greenland P et al (2006) Statin use and functional decline in patients with and without peripheral arterial disease. J Am Coll Cardiol 47:998–1004PubMedCrossRefGoogle Scholar
  33. 33.
    Oka RK, Szuba A, Giacomini JC, Cooke JP (2004) Predictors of physical function in patients with peripheral arterial disease and claudication. Prog Cardiovasc Nurs 19:89–94PubMedCrossRefGoogle Scholar
  34. 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
  35. 35.
    McDermott MM (1999) Ankle brachial index as a predictor of outcomes in peripheral arterial disease. J Lab Clin Med 133:33–40PubMedCrossRefGoogle Scholar
  36. 36.
    Heald CL, Fowkes FG, Murray GD, Price JF (2006) Risk of mortality and cardiovascular disease associated with the ankle-brachial index: systematic review. Ankle Brachial Index Collaboration. Atherosclerosis 189:61–69PubMedCrossRefGoogle Scholar
  37. 37.
    Reed JF 3rd, Eid S, Edris B, Sumner AD (2009) Prevalence of peripheral arterial disease varies significantly depending upon the method of calculating ankle brachial index. Eur J Cardiovasc Prev Rehabil 16:377–381PubMedCrossRefGoogle Scholar
  38. 38.
    Cacoub P, Cambou JP, Kownator S et al (2009) Prevalence of peripheral arterial disease in high-risk patients using ankle-brachial index in general practice: a cross-sectional study. Int J Clin Pract 63:63–70PubMedCrossRefGoogle Scholar
  39. 39.
    Diehm C, Lange S, Darius H et al (2006) Association of low ankle brachial index with high mortality in primary care. Eur Heart J 27:1743–1749PubMedCrossRefGoogle Scholar

Copyright information

© SIMI 2011

Authors and Affiliations

  • Claudio Cimminiello
    • 1
  • Serge Kownator
    • 2
  • Jean-Claude Wautrecht
    • 3
  • Christos P. Carvounis
    • 4
  • Stefanus Eliza Kranendonk
    • 5
  • Beat Kindler
    • 6
  • Mario Mangrella
    • 7
  • Claudio Borghi
    • 8
  • for the PANDORA Study Investigators
  1. 1.Department of MedicineVimercate HospitalVimercate (MI)Italy
  2. 2.Cardiology DepartmentClinique Ambroise ParéThionvilleFrance
  3. 3.Department of Vascular DiseasesHôpital ErasmeBrusselsBelgium
  4. 4.Internal Medicine DepartmentKyanous Stavros Medical CenterAthensGreece
  5. 5.TweeSteden HospitalTilburgThe Netherlands
  6. 6.ZurichSwitzerland
  7. 7.R&D DepartmentAstraZeneca SpABasiglioItaly
  8. 8.Internal Medicine UnitUniversity Hospital Sant’Orsola-MalpighiBolognaItaly

Personalised recommendations