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Randomized Controlled Trial
. 2015 Mar 17;65(10):999-1009.
doi: 10.1016/j.jacc.2014.12.043.

Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study

Timothy P Murphy  1 , Donald E Cutlip  2 , Judith G Regensteiner  3 , Emile R Mohler 3rd  4 , David J Cohen  5 , Matthew R Reynolds  6 , Joseph M Massaro  7 , Beth A Lewis  8 , Joselyn Cerezo  9 , Niki C Oldenburg  10 , Claudia C Thum  6 , Michael R Jaff  11 , Anthony J Comerota  12 , Michael W Steffes  10 , Ingrid H Abrahamsen  6 , Suzanne Goldberg  13 , Alan T Hirsch  10
Affiliations
Randomized Controlled Trial

Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study

Timothy P Murphy et al. J Am Coll Cardiol. .

Erratum in

  • J Am Coll Cardiol. 2015 May 12;65(18):2055

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.

Objectives: 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.

Keywords: angioplasty; ankle-brachial index; cilostazol; exercise rehabilitation; quality of life; walking.

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Figures

Central Illustration
Central Illustration. Exercise or Intervention for Claudication Due to Aortoiliac Peripheral Artery Disease: Peak Walking Time and Claudication Onset Time
Upper Panel: Peak Walking Time (PWT). Patients with 18-month follow-up visit only. Lower Panel: Claudication Onset Time. ABI = ankle brachial index in the most symptomatic leg; COT = claudication onset time on a graded treadmill test; PWT = peak walking time on a graded treadmill test.
Figure 1
Figure 1. CONSORT Diagram
Participants were randomized after consenting for study participation and undergoing eligibility testing. Potentially eligible study participants were screened at the discretion of the study site. The proportion that did not expire, withdraw consent, exit the study, or were not lost to follow-up before completion of the 18-month follow-up was 93/111 (84%). Of the 93 who remained in the study for the entire 18 months of follow-up, treadmill test data were available for 79/111 (71%) at 18 months. Of the 14 who remained in the study for the duration of follow-up, but did not undergo the treadmill test at 18 months, there were 9 in ST, 2 in SE, and 3 in OMC. The reasons for 9 ST participants missing PWT were: could not be contacted (1), comorbid condition (recent laminectomy in 1); out of 2-week window (2), and refused (5, 3 of whom had crossed over to structured exercise). The reasons for 3 OMC participants missing PWT were: comorbid condition (unknown, 1); no show (2). The reasons for 2 SE participants missing PWT were: refused (1) and unknown (1). Of the 14 patients who did not have the 18-month PWT, 7 had other 18-month endpoints collected, and 13 had QOL data collected by telephone. All study participants were confirmed to be alive at the 18-month follow-up interval, except for 1 person in SE who expired before the 6-month follow-up.
Figure 2
Figure 2. Mean (+1 Standard Error) Quality of Life by Treatment Group
Patients with 18-month follow-up visit only. PAQ = Peripheral Artery Questionnaire; WIQ = Walking Impairment Questionnaire.
Figure 2
Figure 2. Mean (+1 Standard Error) Quality of Life by Treatment Group
Patients with 18-month follow-up visit only. PAQ = Peripheral Artery Questionnaire; WIQ = Walking Impairment Questionnaire.
Figure 2
Figure 2. Mean (+1 Standard Error) Quality of Life by Treatment Group
Patients with 18-month follow-up visit only. PAQ = Peripheral Artery Questionnaire; WIQ = Walking Impairment Questionnaire.
Figure 2
Figure 2. Mean (+1 Standard Error) Quality of Life by Treatment Group
Patients with 18-month follow-up visit only. PAQ = Peripheral Artery Questionnaire; WIQ = Walking Impairment Questionnaire.
Figure 2
Figure 2. Mean (+1 Standard Error) Quality of Life by Treatment Group
Patients with 18-month follow-up visit only. PAQ = Peripheral Artery Questionnaire; WIQ = Walking Impairment Questionnaire.
Figure 2
Figure 2. Mean (+1 Standard Error) Quality of Life by Treatment Group
Patients with 18-month follow-up visit only. PAQ = Peripheral Artery Questionnaire; WIQ = Walking Impairment Questionnaire.
Figure 2
Figure 2. Mean (+1 Standard Error) Quality of Life by Treatment Group
Patients with 18-month follow-up visit only. PAQ = Peripheral Artery Questionnaire; WIQ = Walking Impairment Questionnaire.
See this image and copyright information in PMC

Comment in

  • Intervention or exercise?: the answer is yes!
    Sobieszczyk PS, Beckman JA. Sobieszczyk PS, et al. J Am Coll Cardiol. 2015 Mar 17;65(10):1010-2. doi: 10.1016/j.jacc.2015.01.006. J Am Coll Cardiol. 2015. PMID: 25766948 No abstract available.

References

    1. Criqui MH, Denenberg JO, Langer RD, et al. The epidemiology of peripheral arterial disease: importance of identifying the population at risk. Vasc Med. 1997;2:221–6. - PubMed
    1. Fowkes FG, Housley E, Cawood EH, et al. Edinburgh Artery Study: prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population. Int J Epidemiol. 1991;20:384–92. - PubMed
    1. Murabito JM, Evans JC, Nieto K, et al. Prevalence and clinical correlates of peripheral arterial disease in the Framingham Offspring Study. Am Heart J. 2002;143:961–5. - PubMed
    1. Meijer WT, Hoes AW, Rutgers D, et al. Peripheral arterial disease in the elderly: The Rotterdam Study. Arterioscler Thromb Vasc Biol. 1998;18:185–92. - PubMed
    1. Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004;110:738–43. - PubMed

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