title: Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study.
abstract: BACKGROUND
  Treatment for claudication that is due to aortoiliac peripheral artery disease (PAD) often relies on stent revascularization (ST). However, supervised exercise (SE) is known to provide comparable short-term (6-month) improvements in functional status and quality of life. Longer-term outcomes are not known.
  
  
  OBJECTIVE
  The goal of this study was to report the longer-term (18-month) efficacy of SE compared with ST and optimal medical care (OMC).
  
  
  METHODS
  Of 111 patients with aortoiliac PAD randomly assigned to receive OMC, OMC plus SE, or OMC plus ST, 79 completed the 18-month clinical and treadmill follow-up assessment. SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling. Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life.
  
  
  RESULTS
  Peak walking time improved from baseline to 18 months for both SE (5.0 ± 5.4 min) and ST (3.2 ± 4.7 min) significantly more than for OMC (0.2 ± 2.1 min; p < 0.001 and p = 0.04, respectively). The difference between SE and ST was not significant (p = 0.16). Improvement in claudication onset time was greater for SE compared with OMC, but not for ST compared with OMC. Many disease-specific quality-of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC.
  
  
  CONCLUSIONS
  Both SE and ST had better 18-month outcomes than OMC. SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months. The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment.
authors.affiliation: Department of Diagnostic Imaging, Vascular Disease Research Center, Rhode Island Hospital, Providence, Rhode Island. Electronic address: tmurphy@lifespan.org.
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Murphy
authors.affiliation: Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.affiliation: University of Colorado School of Medicine-Aurora, Center for Women's Health Research, Aurora, Colorado.
authors.forename: Judith G
authors.initials: JG
authors.lastname: Regensteiner
authors.affiliation: Section of Vascular Medicine, Cardiovascular Division at Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Emile R
authors.initials: ER
authors.lastname: Mohler
authors.affiliation: Division of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Reynolds
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts; Department of Biostatistics, Boston University, Boston, Massachusetts.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.affiliation: School of Kinesiology, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Beth A
authors.initials: BA
authors.lastname: Lewis
authors.affiliation: Department of Diagnostic Imaging, Vascular Disease Research Center, Rhode Island Hospital, Providence, Rhode Island.
authors.forename: Joselyn
authors.initials: J
authors.lastname: Cerezo
authors.affiliation: Lillehei Heart Institute, Cardiovascular Division, University of Minnesota Medical School, Minneapolis, Minnesota.
authors.forename: Niki C
authors.initials: NC
authors.lastname: Oldenburg
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Claudia C
authors.initials: CC
authors.lastname: Thum
authors.affiliation: Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: Jobst Vascular Institute, Toledo Hospital, Toledo, Ohio.
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Comerota
authors.affiliation: Lillehei Heart Institute, Cardiovascular Division, University of Minnesota Medical School, Minneapolis, Minnesota.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Steffes
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Ingrid H
authors.initials: IH
authors.lastname: Abrahamsen
authors.affiliation: National Heart Lung and Blood Institute, Bethesda, Maryland.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Goldberg
authors.affiliation: Lillehei Heart Institute, Cardiovascular Division, University of Minnesota Medical School, Minneapolis, Minnesota.
authors.forename: Alan T
authors.initials: AT
authors.lastname: Hirsch
mesh_terms: D000368:Aged; D001157:Arterial Occlusive Diseases / Q000150:complications; D015444:Exercise; D005081:Exercise Therapy; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000534:rehabilitation / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D058729:Peripheral Arterial Disease / Q000150:complications; D011788:Quality of Life; D020127:Recovery of Function; D015607:Stents; D016896:Treatment Outcome; D016138:Walking
keywords: angioplasty; ankle-brachial index; cilostazol; exercise rehabilitation; quality of life; walking