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

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, 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 journal › Article › peer-review

171 Scopus citations

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 language	English (US)
Pages (from-to)	999-1009
Number of pages	11
Journal	Journal of the American College of Cardiology
Volume	65
Issue number	10
DOIs	https://doi.org/10.1016/j.jacc.2014.12.043
State	Published - Mar 17 2015

Bibliographical note

Funding Information:
The CLEVER study was a randomized, multicenter clinical trial conducted at 29 centers in the United States and Canada. The study was designed to test the hypothesis that ST plus optimal medical care (OMC) and SE plus OMT would be associated with a greater improvement in peak walking time (PWT) on a graded treadmill test than with OMT alone. The CLEVER study secondarily tested whether ST plus OMT resulted in more improvement in PWT than SE plus OMC. The study was approved by the U.S. Food and Drug Administration, the Canadian Therapeutic Products Directorate, and institutional review boards at all participating centers, and was supported by the National Institutes of Health National Heart, Lung, and Blood Institute. The study has been registered as NCT00132743 since August 19, 2005, and was overseen by an independent data safety and monitoring committee. Details of the study design, methods, and early results were published previously (16,17) . The lead author wrote the first draft of the manuscript, and all coauthors participated in and approved subsequent revisions.

Keywords

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

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Murphy, T. P., Cutlip, D. E., Regensteiner, J. G., Mohler, E. R., Cohen, D. J., Reynolds, M. R., Massaro, J. M., Lewis, B. A., Cerezo, J., Oldenburg, N. C., Thum, C. C., Jaff, M. R., Comerota, A. J., Steffes, M. W., Abrahamsen, I. H., Goldberg, S., & Hirsch, A. T. (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, 65(10), 999-1009. https://doi.org/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. / Murphy, Timothy P.; Cutlip, Donald E.; Regensteiner, Judith G. et al.
In: Journal of the American College of Cardiology, Vol. 65, No. 10, 17.03.2015, p. 999-1009.

Research output: Contribution to journal › Article › peer-review

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

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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. 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",

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

note = "Funding Information: The CLEVER study was a randomized, multicenter clinical trial conducted at 29 centers in the United States and Canada. The study was designed to test the hypothesis that ST plus optimal medical care (OMC) and SE plus OMT would be associated with a greater improvement in peak walking time (PWT) on a graded treadmill test than with OMT alone. The CLEVER study secondarily tested whether ST plus OMT resulted in more improvement in PWT than SE plus OMC. The study was approved by the U.S. Food and Drug Administration, the Canadian Therapeutic Products Directorate, and institutional review boards at all participating centers, and was supported by the National Institutes of Health National Heart, Lung, and Blood Institute. The study has been registered as NCT00132743 since August 19, 2005, and was overseen by an independent data safety and monitoring committee. Details of the study design, methods, and early results were published previously (16,17) . The lead author wrote the first draft of the manuscript, and all coauthors participated in and approved subsequent revisions. ",

year = "2015",

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day = "17",

doi = "10.1016/j.jacc.2014.12.043",

language = "English (US)",

volume = "65",

pages = "999--1009",

journal = "Journal of the American College of Cardiology",

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TY - JOUR

T1 - Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease

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.

N1 - Funding Information: The CLEVER study was a randomized, multicenter clinical trial conducted at 29 centers in the United States and Canada. The study was designed to test the hypothesis that ST plus optimal medical care (OMC) and SE plus OMT would be associated with a greater improvement in peak walking time (PWT) on a graded treadmill test than with OMT alone. The CLEVER study secondarily tested whether ST plus OMT resulted in more improvement in PWT than SE plus OMC. The study was approved by the U.S. Food and Drug Administration, the Canadian Therapeutic Products Directorate, and institutional review boards at all participating centers, and was supported by the National Institutes of Health National Heart, Lung, and Blood Institute. The study has been registered as NCT00132743 since August 19, 2005, and was overseen by an independent data safety and monitoring committee. Details of the study design, methods, and early results were published previously (16,17) . The lead author wrote the first draft of the manuscript, and all coauthors participated in and approved subsequent revisions.

PY - 2015/3/17

Y1 - 2015/3/17

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.

AB - 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.

KW - angioplasty

KW - ankle-brachial index

KW - cilostazol

KW - exercise rehabilitation

KW - quality of life

KW - walking

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

Abstract

Bibliographical note

Keywords

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