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

Volumn 125, Issue 1, 2012, Pages 130-139

  Murphy, Timothy P ^a   Cutlip, Donald E ^b,c   Regensteiner, Judith G ^d   Mohler, Emile R ^e   Cohen, David J ^f   Reynolds, Matthew R ^b,c   Massaro, Joseph M ^g   Lewis, Beth A ^h   Cerezo, Joselyn ^a   Oldenburg, Niki C ⁱ   Thum, Claudia C ^c   Goldberg, Suzanne ^j   Jaff, Michael R ^k   Steffes, Michael W ⁱ   Comerota, Anthony J ^l   Ehrman, Jonathan ^m   Treat Jacobson, Diane ⁿ   Walsh, M Eileen ^o   Collins, Tracie ⁱ   Badenhop, Dalynn T ^o   Bronas, Ulf ⁿ   Hirsch, Alan T ⁱ   more..

^a RHODE ISLAND HOSPITAL   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c HARVARD CLINICAL RESEARCH INSTITUTE   (United States)

^d UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^g BOSTON UNIVERSITY   (United States)

^h UNIVERSITY OF MINNESOTA   (United States)

ⁱ UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^j NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^k MASSACHUSETTS GENERAL HOSPITAL   (United States)

^l JOBST VASCULAR CENTER   (United States)

^m HENRY FORD HOSPITAL   (United States)

ⁿ UNIVERSITY OF MINNESOTA   (United States)

^o UNIVERSITY OF TOLEDO   (United States)

more..

Author keywords

claudication; comparative effectiveness research; peripheral artery disease; vascular diseases

Indexed keywords

ACETYLSALICYLIC ACID; CILOSTAZOL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; THIENOPYRIDINE DERIVATIVE;

ABSENCE OF SIDE EFFECTS; ADULT; ANTICOAGULANT THERAPY; ARTERY DISSECTION; ARTERY PERFORATION; ARTICLE; CARDIOVASCULAR RISK; CLAUDICATION; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HUMAN; ILIAC ARTERY OBSTRUCTION; KINESIOTHERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PATIENT COMPLIANCE; PERIPHERAL ARTERY QUESTIONNAIRE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SHORT FORM 12; SINGLE BLIND PROCEDURE; STENT; SUPERVISED EXERCISE; TREADMILL EXERCISE; TREATMENT RESPONSE; WALKING DIFFICULTY; WALKING IMPAIRMENT QUESTIONNAIRE; WALKING SPEED;

AGED; AORTA; EXERCISE TEST; FEMALE; FEMORAL ARTERY; FOLLOW-UP STUDIES; HUMANS; ILIAC ARTERY; INTERMITTENT CLAUDICATION; MALE; MIDDLE AGED; MYOCARDIAL REVASCULARIZATION; PERIPHERAL ARTERIAL DISEASE; POPLITEAL ARTERY; PROSPECTIVE STUDIES; QUALITY OF LIFE; STENTS; TREATMENT OUTCOME; WALKING;

EID: 83655214994     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.111.075770     Document Type: Article

References (34)

1. Ouriel K. Peripheral arterial disease. Lancet. 2001;358:1257-1264. (Pubitemid 33010855)
2. Barletta G, Perna S, Sabba C, Catalano A, O'Boyle C, Brevetti G. Quality of life in patients with intermittent claudication: relationship with laboratory exercise performance. Vasc Med. 1996;1:3-7. (Pubitemid 26153804)
3. McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment JAMA. 2001; 286:1599-1606. (Pubitemid 33010284)
4. Sieminski DJ, Gardner AW. The relationship between free-living daily physical activity and the severity of peripheral arterial occlusive disease. Vasc Med. 1997;2:286-291. (Pubitemid 28212094)
5. Regensteiner JG, Steiner JF, Hiatt WR. Exercise training improves functional status in patients with peripheral arterial disease. J Vasc Surg. 1996;23:104-115. (Pubitemid 26037967)
6. Feinglass J, McCarthy WJ, Slavensky R, Manheim LM, Martin GJ. Effect of lower extremity blood pressure on physical functioning in patients who have intermittent claudication: the Chicago Claudication Outcomes Research Group. J Vasc Surg. 1996;24:503-511.
7. Stewart KJ, Hiatt WR, Regensteiner JG, Hirsch AT. Exercise training for claudication. N Engl J Med. 2002;347:1941-1951.
8. Leng GC, Fowler B, Ernst E. Exercise for intermittent claudication. Cochrane Database Syst Rev. 2000:CD000990.
9. Murphy TP, Soares GM, Kim HM, Ahn SH, Haas RA. Quality of life and exercise performance after aortoiliac stent placement for claudication. J Vasc Interv Radiol. 2005;16:947-953, quiz 954.
10. Nordanstig J, Gelin J, Hensater M, Taft C, Osterberg K, Jivegard 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.
11. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; 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; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic. Circulation. 2006;113:e463-e654.
12. 100 Initial priority topics for comparative effectiveness research. http://www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx. Accessed October 25, 2011.
13. Perkins JM, Collin J, Creasy TS, Fletcher EW, Morris PJ. Exercise training versus angioplasty for stable claudication: long and medium term results of a prospective, randomised trial. Eur J Vasc Endovasc Surg. 1996;11:409-413. (Pubitemid 26192844)
14. Spronk S, Bosch JL, den Hoed PT, Veen HF, Pattynama PM, Hunink MG. Intermittent claudication: clinical effectiveness of endovascular revascularization versus supervised hospital-based exercise training-randomized controlled trial. Radiology. 2009;250:586-595.
15. Murphy TP, Spronk S, de Ridder M, Lesaffre EM. Primary end-point error. Radiology. 2010;256:1011.
16. Pernow B, Zetterquist S. Metabolic evaluation of the leg blood flow in claudicating patients with arterial obstructions at different levels. Scand J Clin Lab Invest. 1968;21:277-287.
17. Murphy TP, Ariaratnam NS, Carney WI Jr, Marcaccio EJ, Slaiby JM, Soares GM, Kim HM. Aortoiliac insufficiency: long-term experience with stent placement for treatment. Radiology. 2004;231:243-249. (Pubitemid 38379646)
18. Sapoval MR, Long AL, Raynaud AC, Beyssen BM, Fiessinger JN, Gaux JC. Femoropopliteal stent placement: long-term results. Radiology. 1992; 184:833-839.
19. Vroegindeweij D, Vos LD, Tielbeek AV, Buth J, van den Bosch HC. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: a comparative randomized study. Cardiovasc Intervent Radiol. 1997;20:420-425. (Pubitemid 27512031)
20. Laird JR. Limitations of percutaneous transluminal angioplasty and stenting for the treatment of disease of the superficial femoral and popliteal arteries. J Endovasc Ther. 2006;13(suppl 2):II30-II40. (Pubitemid 43273488)
21. Schlager O, Dick P, Sabeti S, Amighi J, Mlekusch W, Minar E, Schillinger M. Long-segment SFA stenting: the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12: 676-684. (Pubitemid 43100925)
22. Murphy TP, Hirsch AT, Ricotta JJ, Cutlip DE, Mohler E, Regensteiner JG, Comerota AJ, Cohen DJ; CLEVER Steering Committee. The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. J Vasc Surg. 2008;47:1356-1363.
23. Bronas UG, Hirsch AT, Murphy T, Badenhop D, Collins TC, Ehrman JK, Ershow AG, Lewis B, Treat-Jacobson DJ, Walsh ME, Oldenburg N, Regensteiner JG; CLEVER Research Group. Design of the multicenter standardized supervised exercise training intervention for the Claudication: Exercise Vs Endoluminal Revascularization (CLEVER) study. Vasc Med. 2009;14:313-321.
24. Gardner AW, Skinner JS, Cantwell BW, Smith LK. Progressive vs single-stage treadmill tests for evaluation of claudication. Med Sci Sports Exerc. 1991;23:402-408.
25. Burnham SJ, Jaques P, Burnham CB. Noninvasive detection of iliac artery stenosis in the presence of superficial femoral artery obstruction. J Vasc Surg. 1992;16:445-451.
26. Shaalan WE, French-Sherry E, Castilla M, Lozanski L, Bassiouny HS. Reliability of common femoral artery hemodynamics in assessing the severity of aortoiliac inflow disease. J Vasc Surg. 2003;37:960-969. (Pubitemid 36538917)
27. Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220-233. (Pubitemid 126433231)
28. Spertus J, Jones P, Poler S, Rocha-Singh K. The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease. Am Heart J. 2004;147:301-308. (Pubitemid 38180531)
29. Hiatt WR, Hirsch AT, Regensteiner JG, Brass EP. Clinical trials for claudication: assessment of exercise performance, functional status, and clinical end points: Vascular Clinical Trialists. Circulation. 1995;92: 614-621.
30. Regensteiner JG, Meyer TJ, Krupski WC, Cranford LS, Hiatt WR. Hospital vs home-based exercise rehabilitation for patients with peripheral arterial occlusive disease. Angiology. 1997;48:291-300. (Pubitemid 27172999)
31. Safley DM, House JA, Laster SB, Daniel WC, Spertus JA, Marso SP. Quantifying improvement in symptoms, functioning, and quality of life after peripheral endovascular revascularization. Circulation. 2007;115: 569-575. (Pubitemid 46226166)
32. Creasy TS, McMillan PJ, Fletcher EWL, Collin J, Morris PJ. Is percutaneous transluminal angioplasty better than exercise for claudication? Preliminary results from a prospective randomized trial. Eur J Vasc Surg. 1990;4:135-140. (Pubitemid 20172197)
33. Mazari FA, Gulati S, Rahman MN, Lee HL, Mehta TA, McCollum PT, Chetter IC. Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication. Ann Vasc Surg. 2010;24:69-79.
34. McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009;301:165-174.