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Hospital-Supervised Exercise May Prevent Need for Surgery in Patients With Claudication

  • Authors: News Author: Laurie Barclay, MD
    CME Author: Désirée Lie, MD, MSEd
  • CME/CE Released: 2/9/2009
  • Valid for credit through: 2/9/2010, 11:59 PM EST
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Target Audience and Goal Statement

This article is intended for primary care clinicians, vascular surgeons, interventional radiologists, cardiologists, and other specialists who care for patients with intermittent claudication.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Compare the effect of endovascular revascularization and hospital-based exercise training on clinical success and symptoms for 12 months in patients with intermittent claudication.
  2. Compare the effect of endovascular revascularization and hospital-based exercise training on functional capacity and quality of life for 12 months in patients with intermittent claudication.


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  • Laurie Barclay, MD

    Laurie Barclay, MD, is a freelance reviewer and writer for Medscape LLC.


    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.


  • Brande Nicole Martin

    Brande Nicole Martin is the News CME editor for Medscape Medical News.


    Disclosure: Brande Nicole Martin has disclosed no relevant financial information.


  • Laurie E. Scudder, MS, NP

    Accreditation Coordinator, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC; Nurse Practitioner, School-Based Health Centers, Baltimore City Public Schools, Baltimore, Maryland


    Disclosure: Laurie Scudder, MS, NP, has disclosed no relevant financial information.

CME Author(s)

  • Désirée Lie, MD, MSEd

    Clinical Professor, Family Medicine, University of California, Orange; Director, Division of Faculty Development, UCI Medical Center, Orange, California


    Disclosure: Désirée Lie, MD, MSEd, has disclosed no relevant financial relationships.

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Hospital-Supervised Exercise May Prevent Need for Surgery in Patients With Claudication

Authors: News Author: Laurie Barclay, MD CME Author: Désirée Lie, MD, MSEdFaculty and Disclosures

CME/CE Released: 2/9/2009

Valid for credit through: 2/9/2010, 11:59 PM EST


February 9, 2009 — Patients with intermittent claudication, or leg pain caused by arterial disease, may be able to forego treatment of the affected artery by participating in hospital-supervised exercise, according to the results of a randomized controlled trial reported in the February issue of Radiology.

"Exercise training is recommended as an initial treatment for intermittent claudication by the TransAtlantic Inter-Society Consensus (TASC)," write Sandra Spronk, PhD, from the Vascular Laboratory, Ikazia Hospital in Rotterdam, the Netherlands, and colleagues. "Endovascular revascularization, however, is becoming more common, presumably because its immediate benefit may prevent unnecessary disability. In a randomized controlled trial, we compared clinical success, functional capacity, and quality of life [QOL] during 12 months of follow-up after endovascular revascularization or supervised hospital-based exercise training in patients with intermittent claudication."

The study sample consisted of 151 consecutive patients who presented with symptoms of intermittent claudication between September 2002 and September 2005. Of 151 patients randomly selected, 76 were assigned to undergo endovascular revascularization (angioplasty-first approach), and 75 to hospital-based supervised exercise. The main endpoints of the study were clinical success, defined as improvement in at least 1 category in the Rutherford scale above the pretreatment level; functional capacity; and QOL after 6 and 12 months.

Multivariable regression analysis adjusted outcomes for imbalances of baseline values and significance of differences between the groups were evaluated with the unpaired t test, the χ2 test, or the Mann-Whitney U test.

Clinical success immediately after the start of treatment was better in patients who underwent revascularization vs those who had supervised exercise (adjusted odds ratio [OR], 39; 99% confidence interval [CI], 11 - 131; P < .001). This difference between groups was not maintained after 6 or 12 months (6-month adjusted OR, 0.9; 99% CI, 0.3 - 2.3; P = .70; 12-month adjusted OR, 1.1; 99% CI, 0.5 - 2.8; P = .73).

Compared with patients in the exercise group, fewer patients in the revascularization group showed signs of ipsilateral symptoms at 6 months (adjusted OR, 0.4; 99% CI, 0.2 - 0.9; P < .001). However, differences were not significant at 12 months. Functional capacity and QOL scores increased after 6 and 12 months in both groups, with no significant differences between groups.

Limitations of this study are that it was a single-center study performed in the Netherlands with strict inclusion and exclusion criteria, limiting generalizability; lack of power; multiple comparisons effect; subjective nature of QOL; lack of use of a graded incline; limitations of the revascularization technique used; and bilateral effect of exercise.

"After 6 and 12 months, patients with intermittent claudication benefited equally from either endovascular revascularization or supervised exercise," the study authors write. "Improvement was, however, more immediate after revascularization."

Radiology. 2009;250:586-595.

Clinical Context

Intermittent claudication is becoming more prevalent, varying from 3% to 6% in those aged 40 to 60 years. Exercise training is recommended as the initial treatment of intermittent claudication, and endovascular revascularization is becoming more common because of the immediate benefits conferred.

This is a randomized trial to compare the relative effectiveness of revascularization and supervised exercise in patients referred to a vascular surgery center with claudication of the lower limbs.

Study Highlights

  • Inclusion criteria were Rutherford category 1, 2, or 3 claudication with duration of at least
    3 months, maximal pain-free walking distance of less than 350 meters, ankle-brachial index of less than 0.9 at rest or decreased by 0.15 or more after the treadmill test, and 1 or more stenoses of more than 50% diameter reduction at the iliac or femoral-popliteal level.
  • Excluded were patients with abdominal aneurysm, incapacitating cardiac disease, previous treatment of the lesion, and multilevel disease.
  • Endovascular revascularization was performed by 1 of 3 interventional radiologists with at least 10 years' experience; a 10% oversized balloon was used for the procedure.
  • Stent diameters were chosen with the aim of 1-mm oversizing on the basis of the vessel diameter proximal and distal to the area of the stenosis.
  • Exercise under the supervision of a vascular technologist was performed for 24 weeks,
    30 minutes per session twice weekly.
  • Workload was initiated at 3.5 km/hour and was reduced after pain occurred.
  • After 24 weeks, patients were instructed to walk at least 3 times weekly for 30 minutes each time.
  • Risk factor treatment of smoking, lipid profile, and hypertension was addressed.
  • Clinical effectiveness was the composite outcome, consisting of clinical success, functional capacity, and QOL.
  • Success was defined as improvement of at least 1 category by the Rutherford scale, measured 1 week after the procedure or after 2 exercise sessions.
  • Contralateral symptoms were assessed as occurrence of any symptoms in the contralateral limb including claudication and rest pain.
  • QOL was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey and the Vascular Quality of Life Questionnaire.
  • 151 patients were enrolled; 75 were randomly assigned to revascularization and 76 to exercise.
  • Mean age was 65 years, slightly more than 50% were men, 37% to 43% had arterial hypertension, 15% to 20% had diabetes mellitus, and more than 50% had hyperlipidemia.
  • In the revascularization group, stents were used in 46 of 71 iliac lesions and in 20 of 40 femoral lesions.
  • In the exercise group, the mean number of sessions was 33, and mean time spent on home walking exercise was 4.2 hours per week.
  • 8 patients in the exercise group crossed over to revascularization.
  • After revascularization, the clinical success rate was 88% at 1 week, 75% at 6 months, and 68% at 12 months.
  • For the exercise group, the respective success rates were 16%, 77%, and 65%.
  • Clinical success was significantly greater in the revascularization group at 1 week (OR, 0.39), but the difference disappeared at 6 and 12 months.
  • At 6 months, fewer patients in the revascularization group had ipsilateral symptoms (OR, 0.4), but the difference disappeared at 12 months.
  • More patients had contralateral claudication symptoms at 6 and 12 months (OR, 2.4), but the difference was not statistically significant.
  • After 12 months, both groups showed similar improvement in mean ankle-brachial index at rest and after exercise, maximal pain-free walking distance, and maximal walking distance.
  • Functional capacity was similar in the 2 groups at 6 and 12 months, as were QOL measures.
  • The authors concluded that revascularization and exercise in patients with intermittent claudication produced similar benefits at 6 and 12 months but that the benefits were more immediate with revascularization.

Pearls for Practice

  • Revascularization in patients with intermittent claudication is associated with similar clinical success and symptom reduction as exercise at 12 months, but clinical success is significantly better at 1 week.
  • Revascularization and exercise are associated with similar improvements in functional capacity and QOL at 6 and 12 months.


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