The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme-for a randomised controlled trial protocol

M Elfghi, F Jordan, D Dunne, I Gibson, J Jones, G Flaherty, S Sultan, W Tawfick, M Elfghi, F Jordan, D Dunne, I Gibson, J Jones, G Flaherty, S Sultan, W Tawfick

Abstract

Background: Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events. Patients with PAD, even in the absence of a history of myocardial infarction or ischemic stroke, have approximately the same relative risk of death from cardiovascular causes as patients with a history of coronary or cerebrovascular disease. Despite the high prevalence of PAD and the strong association with cardiovascular morbidity and mortality, patients with PAD are less likely to receive appropriate treatment for their atherosclerotic risk factors than those who are being treated for coronary artery disease. Atherosclerotic risk factor identification and modification play an important role in reducing the number of adverse outcomes among patients with atherosclerosis. Risk reduction therapy decreases the risk of cardiovascular mortality and morbidity in patients with PAD. In this study, we aim to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors.

Methods: This is a randomised, parallel group, active-control trial to compare the effectiveness of the risk factor modification intervention programme to standard healthcare in a tertiary vascular care centre, in the reduction of modified risk factors in PAD patients. The primary outcome of this study is to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors at 3 and 12 months. The secondary outcomes are to compare the impact of the programme on clinical outcomes in PAD patients at 12 months. Secondary outcomes include amputation-free survival, clinical improvement, haemodynamic improvement, need for revascularisation procedures, outcomes of revascularisation procedures, changes in quality of life and the incidence of adverse events.

Discussion: This study will provide clear evidence on the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors, through a high-quality, well-powered clinical trial.

Trial registration: This trial was registered (11/07/2017) on the European Clinical Trials Database (EudraCT number 2017-002964-41) and ClinicalTrials.gov ( NCT03935776 ) which was registered on 02 May 2019.

Keywords: Atherosclerosis; Lifestyle and risk factor modification intervention programme; PAD; Peripheral arterial disease; Randomised controlled trial; Risk factors.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Participant flowchart through the study
Fig. 2
Fig. 2
SPIRIT figure showing an overview of the assessment schedule at baseline and follow-up in study. ABI: ankle-brachial Index, WIfI: wound ischaemia and foot infection classification, HbA1c: glycosylated haemoglobin, BMI: body mass index, HADS: Hospital Anxiety and Depression Scale, MACE: major adverse cardiovascular event and MALE: major adverse limb event

References

    1. Fowkes FGR, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382(9901):1329–1340. doi: 10.1016/S0140-6736(13)61249-0.
    1. Newman AB, Shemanski L, Manolio TA, Cushman M, Mittelmark M, Polak JF, et al. Ankle-arm index as a predictor of cardiovascular disease and mortality in the cardiovascular health study. Arterioscler Thromb Vasc Biol. 1999;19(3):538–545. doi: 10.1161/01.ATV.19.3.538.
    1. Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. Jama. 2001;286(11):1317–1324. doi: 10.1001/jama.286.11.1317.
    1. Becker GJ, McClenny TE, Kovacs ME, Raabe RD, Katzen BT. The importance of increasing public and physician awareness of peripheral arterial disease. J Vasc Interv Radiol. 2002;13(1):7–11. doi: 10.1016/S1051-0443(07)60002-5.
    1. Criqui MH, Fronek A, Klauber MR, Barrett-Connor E, Gabriel S. The sensitivity, specificity, and predictive value of traditional clinical evaluation of peripheral arterial disease: results from noninvasive testing in a defined population. Circulation. 1985;71(3):516–522. doi: 10.1161/01.CIR.71.3.516.
    1. Ix JH, Allison MA, Denenberg JO, Cushman M, Criqui MH. Novel cardiovascular risk factors do not completely explain the higher prevalence of peripheral arterial disease among African Americans: The San Diego Population Study. J Am Coll Cardiol. 2008;51(24):2347–2354. doi: 10.1016/j.jacc.2008.03.022.
    1. Newman AB, Siscovick DS, Manolio TA, Polak J, Fried LP, Borhani NO, et al. Ankle-arm index as a marker of atherosclerosis in the cardiovascular health study. Cardiovascular Heart Study (CHS) Collaborative Research Group. Circulation. 1993;88(3):837–845. doi: 10.1161/01.CIR.88.3.837.
    1. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic) Circulation. 2006;113(11):e463–e654. doi: 10.1161/CIRCULATIONAHA.106.174526.
    1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II) Eur J Vasc Endovasc Surg. 2007;33(1):S1–S75. doi: 10.1016/j.ejvs.2006.09.024.
    1. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline) Vasc Med. 2011;16(6):452. doi: 10.1177/1358863X11424312.
    1. Conte MS, Pomposelli FB, Clair DG, Geraghty PJ, McKinsey JF, Mills JL, et al. Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication. J Vasc Surg. 2015;61(3):2S–41S. doi: 10.1016/j.jvs.2014.12.009.
    1. Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts) Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR) Eur Heart J. 2016;37(29):2315–2381. doi: 10.1093/eurheartj/ehw106.
    1. Lu J, Creager M. The relationship of cigarette smoking to peripheral arterial disease. Rev Cardiovasc Med. 2003;5(4):189–193.
    1. Kotseva K, Connolly SB, Jennings C, Mead A, Jones J, Holden A, et al. EUROACTION: An ESC project in preventive cardiology programme in coronary and high risk patients and their partners. 2007. p. 285.
    1. Wood D, Kotseva K, Jennings C, Mead A, Jones J, Holden A, et al. EUROACTION: a European Society of Cardiology demonstration project in preventive cardiology - a cluster randomised controlled trial of a multi-disciplinary preventive cardiology programme for coronary patients, asymptomatic high risk individuals and their families. Summary of design, methodology and outcomes. Eur Heart J Suppl. 2004;6(J):J3–J15. doi: 10.1093/eurheartj/6.suppl_j.j3.
    1. Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U, et al. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009;373(9667):929–940. doi: 10.1016/S0140-6736(09)60330-5.
    1. Stoner MC, Calligaro KD, Chaer RA, Dietzek AM, Farber A, Guzman RJ, et al. Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease. J Vasc Surg. 2016;64(1):e1–e21. doi: 10.1016/j.jvs.2016.03.420.
    1. McHorney CA, Ware JE Jr, Rogers W, Raczek AE, Lu JR. The validity and relative precision of MOS short-and long-form health status scales and Dartmouth COOP charts: results from the Medical Outcomes Study. Med Care. 1992:MS253–MS65.
    1. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et al. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26(3):517–538. doi: 10.1016/S0741-5214(97)70045-4.
    1. Lewis R. Understanding chronic kidney disease: a guide for the non-specialist. Cumbria: M&K Update Ltd; 2012.
    1. Elfghi M, Jordan F, TawfIck W. SWAT 84: Same-day consent vs delayed consent in a randomised trial. The Northern Ireland Network for Trials Methodology Research. 2018. online, available at: . [Accessed on 12/3/2018].
    1. Mills JL, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, et al. The society for vascular surgery lower extremity threatened limb classification system: risk stratification based on wound, ischemia, and foot infection (WIfI) J Vasc Surg. 2014;59(1):220–234. doi: 10.1016/j.jvs.2013.08.003.
    1. Liu NY-S, Plowman SA, Looney MA. The reliability and validity of the 20-meter shuttle test in American students 12 to 15 years old. Res Q Exerc Sport. 1992;63(4):360–365. doi: 10.1080/02701367.1992.10608757.
    1. Kruidenier LM, Nicolaï SP, Willigendael EM, de Bie RA, Prins MH, Teijink JA. Functional claudication distance: a reliable and valid measurement to assess functional limitation in patients with intermittent claudication. BMC Cardiovasc Disord. 2009;9(1):9. doi: 10.1186/1471-2261-9-9.
    1. Fabry R, Dubost J-J, Pochon P, Duchene-Marullaz P. Comparison of standard one-minute treadmill exercise and strandness test (absolute walking distance) in relation to site of lesion, walking distance, and diastolic blood flow velocity (Doppler curves) Angiology. 1990;41(10):869–876. doi: 10.1177/000331979004101009.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerström test for nicotine dependence: a revision of the Fagerstrom Tolerance Questionnaire. Addiction. 1991;86(9):1119–1127. doi: 10.1111/j.1360-0443.1991.tb01879.x.
    1. Godin G, Shephard R. Godin leisure-time exercise questionnaire. Med Sci Sports Exerc. 1997;29(6):36–38.
    1. Martinez-Gonzalez M, Fernandez-Jarne E, Serrano-Martinez M, Wright M, Gomez-Gracia E. Development of a short dietary intake questionnaire for the quantitative estimation of adherence to a cardioprotective Mediterranean diet. Eur J Clin Nutr. 2004;58(11):1550–1552. doi: 10.1038/sj.ejcn.1602004.
    1. Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, et al. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008;371(9629):1999–2012. doi: 10.1016/S0140-6736(08)60868-5.
    1. Faul F, Erdfelder E, Lang A-G, Buchner A. G* Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–191. doi: 10.3758/BF03193146.
    1. Gibson I, Flaherty G, Cormican S, Jones J, Kerins C, Walsh AM, Costello C, Windle J, Connolly S, Crowley J. Translating guidelines to practice: findings from a multidisciplinary preventive cardiology programme in the west of Ireland. Eur J Prev Cardiol. 2014;21(3):366–376. doi: 10.1177/2047487313498831.
    1. Shammas NW. Epidemiology, classification, and modifiable risk factors of peripheral arterial disease. Vasc Health Risk Manag. 2007;3(2):229. doi: 10.2147/vhrm.2007.3.2.229.
    1. Price J, Mowbray PI, Lee AJ, Rumley A, Lowe GD, Fowkes FG. Relationship between smoking and cardiovascular risk factors in the development of peripheral arterial disease and coronary artery disease; Edinburgh Artery Study: Edinburgh Artery Study. Eur Heart J. 1999;20(5):344–353. doi: 10.1053/euhj.1998.1194.
    1. Bendermacher BL, Willigendael EM, Teijink JA, Prins MH. Medical management of peripheral arterial disease. J Thromb Haemost. 2005;3(8):1628–1637. doi: 10.1111/j.1538-7836.2005.01368.x.
    1. General Assembly of the World Medical Association World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dentists. 2014;81(3):14.

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