Timothy P Murphy1, Donald E Cutlip2, Judith G Regensteiner3, Emile R Mohler4, David J Cohen5, Matthew R Reynolds6, Joseph M Massaro7, Beth A Lewis8, Joselyn Cerezo9, Niki C Oldenburg10, Claudia C Thum6, Michael R Jaff11, Anthony J Comerota12, Michael W Steffes10, Ingrid H Abrahamsen6, Suzanne Goldberg13, Alan T Hirsch10. 1. Department of Diagnostic Imaging, Vascular Disease Research Center, Rhode Island Hospital, Providence, Rhode Island. Electronic address: tmurphy@lifespan.org. 2. Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts. 3. University of Colorado School of Medicine-Aurora, Center for Women's Health Research, Aurora, Colorado. 4. Section of Vascular Medicine, Cardiovascular Division at Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania. 5. Division of Cardiology, University of Missouri-Kansas City, Kansas City, Missouri. 6. Harvard Clinical Research Institute, Boston, Massachusetts. 7. Harvard Clinical Research Institute, Boston, Massachusetts; Department of Biostatistics, Boston University, Boston, Massachusetts. 8. School of Kinesiology, University of Minnesota, Minneapolis, Minnesota. 9. Department of Diagnostic Imaging, Vascular Disease Research Center, Rhode Island Hospital, Providence, Rhode Island. 10. Lillehei Heart Institute, Cardiovascular Division, University of Minnesota Medical School, Minneapolis, Minnesota. 11. Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts. 12. Jobst Vascular Institute, Toledo Hospital, Toledo, Ohio. 13. National Heart Lung and Blood Institute, Bethesda, Maryland.
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.
RCT Entities:
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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