Background
Treatment for claudication due to aortoiliac peripheral artery disease (PAD) often relies on stent revascularization. However, supervised exercise 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 supervised exercise compared with stenting and optimal medical care.
Methods
Of 111 patients with aortoiliac PAD randomly assigned to receive optimal medical care (OMC), OMC plus supervised exercise (SE), or OMC plus stent revascularization (ST), 79 completed the 18-month clinical and treadmill follow-up assessment. SE consisted of 6 months of supervised exercise 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; p < 0.001) compared with OMC (0.2 ± 2.1 min, p = 0.04). The difference between SE and ST was not significant (p = 0.16). Improvement in claudication onset time (COT) 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.
Claudication: Exercise Versus Endoluminal Revascularization [CLEVER]: NCT00132743