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

Timothy P. Murphy, Donald E. Cutlip, Judith G. Regensteiner, Emile R. Mohler, David J. Cohen, Matthew R. Reynolds, Joseph M. Massaro, Beth A. Lewis, Joselyn Cerezo, Niki C. Oldenburg, Claudia C. Thum, Michael R. Jaff, Anthony J. Comerota, Michael W. Steffes, Ingrid H. Abrahamsen, Suzanne Goldberg, Alan T. Hirsch

Research output: Contribution to journalArticle

89 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)999-1009
Number of pages11
JournalJournal of the American College of Cardiology
Volume65
Issue number10
DOIs
StatePublished - Jan 1 2015

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Peripheral Arterial Disease
Stents
Exercise
Therapeutics
Quality of Life
Walking
Telephone
Counseling

Keywords

  • angioplasty
  • ankle-brachial index
  • cilostazol
  • exercise rehabilitation
  • quality of life
  • walking

Cite this

Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease : The CLEVER study. / Murphy, Timothy P.; Cutlip, Donald E.; Regensteiner, Judith G.; Mohler, Emile R.; Cohen, David J.; Reynolds, Matthew R.; Massaro, Joseph M.; Lewis, Beth A.; Cerezo, Joselyn; Oldenburg, Niki C.; Thum, Claudia C.; Jaff, Michael R.; Comerota, Anthony J.; Steffes, Michael W.; Abrahamsen, Ingrid H.; Goldberg, Suzanne; Hirsch, Alan T.

In: Journal of the American College of Cardiology, Vol. 65, No. 10, 01.01.2015, p. 999-1009.

Research output: Contribution to journalArticle

Murphy, TP, Cutlip, DE, Regensteiner, JG, Mohler, ER, Cohen, DJ, Reynolds, MR, Massaro, JM, Lewis, BA, Cerezo, J, Oldenburg, NC, Thum, CC, Jaff, MR, Comerota, AJ, Steffes, MW, Abrahamsen, IH, Goldberg, S & Hirsch, AT 2015, 'Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: The CLEVER study', Journal of the American College of Cardiology, vol. 65, no. 10, pp. 999-1009. https://doi.org/10.1016/j.jacc.2014.12.043
Murphy, Timothy P. ; Cutlip, Donald E. ; Regensteiner, Judith G. ; Mohler, Emile R. ; Cohen, David J. ; Reynolds, Matthew R. ; Massaro, Joseph M. ; Lewis, Beth A. ; Cerezo, Joselyn ; Oldenburg, Niki C. ; Thum, Claudia C. ; Jaff, Michael R. ; Comerota, Anthony J. ; Steffes, Michael W. ; Abrahamsen, Ingrid H. ; Goldberg, Suzanne ; Hirsch, Alan T. / Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease : The CLEVER study. In: Journal of the American College of Cardiology. 2015 ; Vol. 65, No. 10. pp. 999-1009.
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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.",
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T2 - The CLEVER study

AU - Murphy, Timothy P.

AU - Cutlip, Donald E.

AU - Regensteiner, Judith G.

AU - Mohler, Emile R.

AU - Cohen, David J.

AU - Reynolds, Matthew R.

AU - Massaro, Joseph M.

AU - Lewis, Beth A.

AU - Cerezo, Joselyn

AU - Oldenburg, Niki C.

AU - Thum, Claudia C.

AU - Jaff, Michael R.

AU - Comerota, Anthony J.

AU - Steffes, Michael W.

AU - Abrahamsen, Ingrid H.

AU - Goldberg, Suzanne

AU - Hirsch, Alan T.

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N2 - 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.

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KW - ankle-brachial index

KW - cilostazol

KW - exercise rehabilitation

KW - quality of life

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