Improved quality of life after 1 year with an invasive versus a noninvasive treatment strategy in claudicants: One-year results of the invasive revascularization or not in intermittent claudication (IRONIC) trial

Circulation

Volumn 130, Issue 12, 2014, Pages 939-947

  Nordanstig, Joakim ^a   Taft, Charles ^b   Hensäter, Marlene ^a   Perlander, Angelica ^a   Österberg, Klas ^a   Jivegård, Lennart ^a  

^a SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^b UNIVERSITY OF GOTHENBURG   (Sweden)

Author keywords

Intermittent claudication; Peripheral arterial disease; Quality of life; Revascularization

Indexed keywords

ACETYLSALICYLIC ACID; CILOSTAZOL; CLOPIDOGREL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

AGED; ARTICLE; CONTROLLED STUDY; FEMALE; FOLLOW UP; HEART MUSCLE REVASCULARIZATION; HUMAN; HYPOTHESIS; IMAGE ANALYSIS; INTERMETHOD COMPARISON; INTERMITTENT CLAUDICATION; INVASIVE PROCEDURE; LIFESTYLE; MAJOR CLINICAL STUDY; MALE; MEDICAL OUTCOMES STUDY SHORT FORM 36; NON INVASIVE PROCEDURE; OPEN STUDY; PARALLEL DESIGN; PHYSICAL CAPACITY; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 36; TREADMILL TEST; ULTRASOUND; VASCULAR QUALITY OF LIFE QUESTIONNAIRE; WALKING; COMPARATIVE STUDY; MIDDLE AGED; PSYCHOLOGY;

AGED; FEMALE; HUMANS; INTERMITTENT CLAUDICATION; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; QUALITY OF LIFE; QUESTIONNAIRES;

EID: 84923204041     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.114.009867     Document Type: Article

References (32)

1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382:1329-1340.
2. Fowkes FG. Epidemiology of atherosclerotic arterial disease in the lower limbs. Eur J Vasc Surg. 1988;2:283-291.
3. Leng GC, Lee AJ, Fowkes FG, Whiteman M, Dunbar J, Housley E, Ruckley CV. Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. Int J Epidemiol. 1996;25:1172-1181.
4. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5-S67.
5. Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Röther J, Sievert H, van Sambeek M, Zeller T; European Stroke Organisation; ESC Committee for Practice Guidelines. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851-2906.
6. Fokkenrood HJ, Bendermacher BL, Lauret GJ, Willigendael EM, Prins MH, Teijink JA. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2013;8:CD005263.
7. Bermingham SL, Sparrow K, Mullis R, Fox M, Shearman C, Bradbury A, Michaels J. The cost-effectiveness of supervised exercise for the treatment of intermittent claudication. Eur J Vasc Endovasc Surg. 2013;46:707-714.
8. Makris GC, Lattimer CR, Lavida A, Geroulakos G. Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. Eur J Vasc Endovasc Surg. 2012;44:569-575; discussion 576.
9. Layden J, Michaels J, Bermingham S, Higgins B; Guideline Development Group. Diagnosis and management of lower limb peripheral arterial disease: summary of NICE guidance. BMJ. 2012;345:e4947.
10. Nylaende M, Abdelnoor M, Stranden E, Morken B, Sandbaek G, Risum Ø, Jørgensen JJ, Lindahl AK, Arnesen H, Seljeflot I, Kroese AJ. The Oslo Balloon Angioplasty Versus Conservative Treatment Study (OBACT): the 2-years results of a single centre, prospective, randomised study in patients with intermittent claudication. Eur J Vasc Endovasc Surg. 2007;33:3-12.
11. Greenhalgh RM, Belch JJ, Brown LC, Gaines PA, Gao L, Reise JA, Thompson SG; MIMIC Trial Participants. The adjuvant benefit of angioplasty in patients with mild to moderate intermittent claudication (MIMIC) managed by supervised exercise, smoking cessation advice and best medical therapy: results from two randomised trials for stenotic femoropopliteal and aortoiliac arterial disease. Eur J Vasc Endovasc Surg. 2008;36:680-688.
12. Mazari FA, Khan JA, Carradice D, Samuel N, Abdul Rahman MN, Gulati S, Lee HL, Mehta TA, McCollum PT, Chetter IC. Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined treatment for intermittent claudication due to femoropopliteal arterial disease. Br J Surg. 2012;99:39-48.
13. Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT; CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study. Circulation. 2012;125:130-139.
14. Bergqvist D, Delle M, Eckerlund I, Holst J, Jogestrand T, Jörneskog G, Klevsgård R, Marké L-Å, Mattiasson I, Rolandsson O, Syversson A, Säwe J, Troeng T, Wahlberg E. Peripheral arterial disease: diagnosis and treatment: the Swedish Council on Technology Assessment in Health Care. Sys Rev. 2007.
15. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975;31:103-115.
16. Sullivan M, Karlsson J, Taft C. SF-36 hälsoenkät: Svensk manual och tolkningsguide, 2:A upplagan (Swedish Manual and Interpretion Guide, 2nd edition). Gothenburg, Sweden: Sahlgrenska University Hospital; 2002.
17. Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey I: evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995;41:1349-1358.
18. Sullivan M, Karlsson J. The Swedish SF-36 Health Survey III: evaluation of criterion-based validity: results from normative population. J Clin Epidemiol. 1998;51:1105-1113.
19. Nordanstig J, Karlsson J, Pettersson M, Wann-Hansson C. Psychometric properties of the disease-specific health-related quality of life instrument VascuQoL in a Swedish setting. Health Qual Life Outcomes. 2012;10:45.
20. de Vries M, Ouwendijk R, Kessels AG, de Haan MW, Flobbe K, Hunink MG, van Engelshoven JM, Nelemans PJ. Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease. J Vasc Surg. 2005;41:261-268.
21. Mehta T, Venkata Subramaniam A, Chetter I, McCollum P. Assessing the validity and responsiveness of disease-specific quality of life instruments in intermittent claudication. Eur J Vasc Endovasc Surg. 2006;31:46-52.
22. Nordanstig J, Gelin J, Hensäter M, Taft C, Österberg K, Jivegård L. Walking performance and health-related quality of life after surgical or endovascular invasive versus non-invasive treatment for intermittent claudication: a prospective randomised trial. Eur J Vasc Endovasc Surg. 2011;42:220-227.
23. Cohen J. Statistical Power Analysis for the Behavioural Sciences. San Diego, CA. Academic Press. 1977.
24. Holm S. A simple sequentially rejective multiple test procedure. Scand J Stat. 1979;6:65-70.
25. Thompson PD, Zimet R, Forbes WP, Zhang P. Meta-analysis of results from eight randomized, placebo-controlled trials on the effect of cilostazol on patients with intermittent claudication. Am J Cardiol. 2002;90:1314-1319.
26. Frans FA, Bipat S, Reekers JA, Legemate DA, Koelemay MJ; SUPER Study Collaborators. SUPERvised exercise therapy or immediate PTA for intermittent claudication in patients with an iliac artery obstruction: a multicentre randomised controlled trial; SUPER study design and rationale. Eur J Vasc Endovasc Surg. 2012;43:466-471.
27. Visser K, de Vries SO, Kitslaar PJ, van Engelshoven JM, Hunink MG. Cost-effectiveness of diagnostic imaging work-up and treatment for patients with intermittent claudication in the Netherlands. Eur J Vasc Endovasc Surg. 2003;25:213-223.
28. Brevetti G, Annecchini R, Bucur R. Intermittent claudication: pharmacoeconomic and quality-of-life aspects of treatment. Pharmacoeconomics. 2002;20:169-181.
29. Mazari FA, Carradice D, Rahman MN, Khan JA, Mockford K, Mehta T, McCollum PT, Chetter IC. An analysis of relationship between quality of life indices and clinical improvement following intervention in patients with intermittent claudication due to femoropopliteal disease. J Vasc Surg. 2010;52:77-84.
30. Frans FA, Zagers MB, Jens S, Bipat S, Reekers JA, Koelemay MJ. The relationship of walking distances estimated by the patient, on the corridor and on a treadmill, and the Walking Impairment Questionnaire in intermittent claudication. J Vasc Surg. 2013;57:720-727.e1.
31. Nordanstig J, Karlsson J, Pettersson M, Wann-Hansson C. Psychometric properties of the disease-specific health-related quality of life instrument VascuQoL in a Swedish setting. Health Qual Life Outcomes. 2012;10:45.
32. Gelin J, Jivegård L, Taft C, Karlsson J, Sullivan M, Dahllöf AG, Sandström R, Arfvidsson B, Lundholm K. Treatment efficacy of intermittent claudication by surgical intervention, supervised physical exercise training compared to no treatment in unselected randomised patients I: one year results of functional and physiological improvements. Eur J Vasc Endovasc Surg. 2001;22:107-113.