title: 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.
abstract: BACKGROUND
  Claudication is a common and disabling symptom of peripheral artery disease that can be treated with medication, supervised exercise (SE), or stent revascularization (ST).
  
  
  RESULTS
  We randomly assigned 111 patients with aortoiliac peripheral artery disease to receive 1 of 3 treatments: optimal medical care (OMC), OMC plus SE, or OMC plus ST. The primary end point was the change in peak walking time on a graded treadmill test at 6 months compared with baseline. Secondary end points included free-living step activity, quality of life with the Walking Impairment Questionnaire, Peripheral Artery Questionnaire, Medical Outcomes Study 12-Item Short Form, and cardiovascular risk factors. At the 6-month follow-up, change in peak walking time (the primary end point) was greatest for SE, intermediate for ST, and least with OMC (mean change versus baseline, 5.8±4.6, 3.7±4.9, and 1.2±2.6 minutes, respectively; P<0.001 for the comparison of SE versus OMC, P=0.02 for ST versus OMC, and P=0.04 for SE versus ST). Although disease-specific quality of life as assessed by the Walking Impairment Questionnaire and Peripheral Artery Questionnaire also improved with both SE and ST compared with OMC, for most scales, the extent of improvement was greater with ST than SE. Free-living step activity increased more with ST than with either SE or OMC alone (114±274 versus 73±139 versus -6±109 steps per hour), but these differences were not statistically significant.
  
  
  CONCLUSIONS
  SE results in superior treadmill walking performance than ST, even for those with aortoiliac peripheral artery disease. The contrast between better walking performance for SE and better patient-reported quality of life for ST warrants further study.
  
  
  BACKGROUND
  URL: http://clinicaltrials.gov/ct/show/NCT00132743?order=1. Unique identifier: NCT00132743.
authors.affiliation: Vascular Disease Research Center, Rhode Island Hospital, Gerry 337, 593 Eddy St, Providence, RI 02903, USA. tmurphy@lifespan.org
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Murphy
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Judith G
authors.initials: JG
authors.lastname: Regensteiner
authors.forename: Emile R
authors.initials: ER
authors.lastname: Mohler
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Reynolds
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.forename: Beth A
authors.initials: BA
authors.lastname: Lewis
authors.forename: Joselyn
authors.initials: J
authors.lastname: Cerezo
authors.forename: Niki C
authors.initials: NC
authors.lastname: Oldenburg
authors.forename: Claudia C
authors.initials: CC
authors.lastname: Thum
authors.forename: Suzanne
authors.initials: S
authors.lastname: Goldberg
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.forename: Michael W
authors.initials: MW
authors.lastname: Steffes
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Comerota
authors.forename: Jonathan
authors.initials: J
authors.lastname: Ehrman
authors.forename: Diane
authors.initials: D
authors.lastname: Treat-Jacobson
authors.forename: M Eileen
authors.initials: ME
authors.lastname: Walsh
authors.forename: Tracie
authors.initials: T
authors.lastname: Collins
authors.forename: Dalynn T
authors.initials: DT
authors.lastname: Badenhop
authors.forename: Ulf
authors.initials: U
authors.lastname: Bronas
authors.forename: Alan T
authors.initials: AT
authors.lastname: Hirsch
mesh_terms: D000368:Aged; D001011:Aorta / Q000473:pathology*; D005080:Exercise Test / Q000295:instrumentation / Q000379:methods*; D005260:Female; D005263:Femoral Artery / Q000473:pathology; D005500:Follow-Up Studies; D006801:Humans; D007083:Iliac Artery / Q000473:pathology*; D007383:Intermittent Claudication / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000295:instrumentation* / Q000379:methods; D058729:Peripheral Arterial Disease / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011150:Popliteal Artery / Q000473:pathology; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D015607:Stents; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology
references.citation: N Engl J Med. 2002 Dec 12;347(24):1941-51
references.pmid: 12477945
references.citation: Med Care. 1996 Mar;34(3):220-33
references.pmid: 8628042
references.citation: Radiology. 2004 Apr;231(1):243-9
references.pmid: 15068949
references.citation: J Vasc Surg. 1996 Oct;24(4):503-11; discussion 511-2
references.pmid: 8911399
references.citation: J Endovasc Ther. 2005 Dec;12(6):676-84
references.pmid: 16363897
references.citation: Vasc Med. 1996;1(1):3-7
references.pmid: 9546911
references.citation: Eur J Vasc Endovasc Surg. 2011 Aug;42(2):220-7
references.pmid: 21397530
references.citation: Vasc Med. 1997 Nov;2(4):286-91
references.pmid: 9575600
references.citation: Circulation. 1995 Aug 1;92(3):614-21
references.pmid: 7634476
references.citation: Cochrane Database Syst Rev. 2000;(2):CD000990
references.pmid: 10796572
references.citation: Cardiovasc Intervent Radiol. 1997 Nov-Dec;20(6):420-5
references.pmid: 9354709
references.citation: Angiology. 1997 Apr;48(4):291-300
references.pmid: 9112877
references.citation: J Vasc Surg. 2008 Jun;47(6):1356-63
references.pmid: 18440181
references.citation: Radiology. 2010 Sep;256(3):1011; author reply 1011-2
references.pmid: 20720082
references.citation: J Vasc Surg. 1996 Jan;23(1):104-15
references.pmid: 8558725
references.citation: Am Heart J. 2004 Feb;147(2):301-8
references.pmid: 14760329
references.citation: Circulation. 2006 Mar 21;113(11):e463-654
references.pmid: 16549646
references.citation: Vasc Med. 2009 Nov;14(4):313-21
references.pmid: 19808716
references.citation: Scand J Clin Lab Invest. 1968;21(3):277-87
references.pmid: 5708696
references.citation: Lancet. 2001 Oct 13;358(9289):1257-64
references.pmid: 11675083
references.citation: J Vasc Surg. 2003 May;37(5):960-9
references.pmid: 12756340
references.citation: J Endovasc Ther. 2006 Feb;13 Suppl 2:II30-40
references.pmid: 16472009
references.citation: Med Sci Sports Exerc. 1991 Apr;23(4):402-8
references.pmid: 2056896
references.citation: Eur J Vasc Endovasc Surg. 1996 May;11(4):409-13
references.pmid: 8846172
references.citation: JAMA. 2001 Oct 3;286(13):1599-606
references.pmid: 11585483
references.citation: Eur J Vasc Surg. 1990 Apr;4(2):135-40
references.pmid: 2140987
references.citation: Ann Vasc Surg. 2010 Jan;24(1):69-79
references.pmid: 19762206
references.citation: J Vasc Interv Radiol. 2005 Jul;16(7):947-53; quiz 954
references.pmid: 16002502
references.citation: JAMA. 2009 Jan 14;301(2):165-74
references.pmid: 19141764
references.citation: Radiology. 2009 Feb;250(2):586-95
references.pmid: 19188327
references.citation: J Vasc Surg. 1992 Sep;16(3):445-51; discussion 452
references.pmid: 1522648
references.citation: Radiology. 1992 Sep;184(3):833-9
references.pmid: 1509075
references.citation: Circulation. 2007 Feb 6;115(5):569-75
references.pmid: 17242281