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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 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 )

Purpose To describe the experience and results from the roll-in phase of the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study. Materials and Methods The CORAL roll-in database was used to describe the baseline characteristics of the patients in the roll-in cohort, all of whom underwent renal artery stent placement; to evaluate CORAL site performance; to compare estimates of lesion (stenosis) severity made by site interventionalists with the central CORAL angiographic core laboratory readings; and to report outcomes after renal artery stent placement. During the roll-in phase, 239 patients (mean age, 70.2 y ± 9.0; 49% male) underwent renal artery stent procedures. Angiographic core laboratory analysis of renal arteriograms was done, and participants were followed at 1 month and 9 months. Results Major angiographic complications were identified in 28 (13%) subjects. Kidney function remained unchanged at the short (2–4 weeks) follow-up interval. Improvement in systolic blood pressure with use of distal embolic protection devices (n = 161) did not show any clinical benefit over nonuse of such devices (n = 78) in this small series. At 9 months, there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis ( P = .01) and prior history of stroke ( P = .03). Conclusions In the roll-in phase of the CORAL study, a significant number of angiographic complications were identified. No effect was seen on estimated glomerular filtration rate after renal artery stent placement, but systolic blood pressure decreased significantly.

Background— Claudication is a common and disabling symptom of peripheral artery disease that can be treated with medication, supervised exercise (SE), or stent revascularization (ST). Methods and Results— We randomly assigned 111 patients with aortoiliac peripheral artery disease to receive 1 of 3 treatments: optimal medical care (OMC), OMC plus SE, or OMC plus ST. The primary end point was the change in peak walking time on a graded treadmill test at 6 months compared with baseline. Secondary end points included free-living step activity, quality of life with the Walking Impairment Questionnaire, Peripheral Artery Questionnaire, Medical Outcomes Study 12-Item Short Form, and cardiovascular risk factors. At the 6-month follow-up, change in peak walking time (the primary end point) was greatest for SE, intermediate for ST, and least with OMC (mean change versus baseline, 5.8±4.6, 3.7±4.9, and 1.2±2.6 minutes, respectively; P P =0.02 for ST versus OMC, and P =0.04 for SE versus ST). Although disease-specific quality of life as assessed by the Walking Impairment Questionnaire and Peripheral Artery Questionnaire also improved with both SE and ST compared with OMC, for most scales, the extent of improvement was greater with ST than SE. Free-living step activity increased more with ST than with either SE or OMC alone (114±274 versus 73±139 versus −6±109 steps per hour), but these differences were not statistically significant. Conclusions— SE results in superior treadmill walking performance than ST, even for those with aortoiliac peripheral artery disease. The contrast between better walking performance for SE and better patient-reported quality of life for ST warrants further study. Clinical Trial Registration— URL: http://clinicaltrials.gov/ct/show/NCT00132743?order=1 . Unique identifier: NCT00132743.

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.The goal of this study was to report the longer-term (18-month) efficacy of SE compared with ST and optimal medical care (OMC).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.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; p0.001 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.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.

To examine the relationship between objective treadmill test outcomes and subjective symptom outcomes among patients with claudication treated with stent revascularization (ST) compared with supervised exercise (SE).Five scales of the Peripheral Artery Questionnaire and Walking Impairment Questionnaire were correlated with peak walking time and treadmill claudication onset time.The correlation between change in disease-specific quality of life (QOL) and change in peak walking time differed according to treatment group, with statistically significant correlations for all five scales for the ST group and weaker trends for the SE group, only one of which was statistically significant. In contrast, improvements in disease-specific QOL correlated well with increases in claudication onset time, with no significant interaction with treatment group for any of the five scales.Disease-specific QOL results at 6 months in the Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study show that improved maximal treadmill walking in patients with claudication treated with SE correlated poorly with self-reported symptom relief. Conversely, patients treated with ST showed good correlation between improved maximal treadmill walking and self-reported symptom improvement. The correlation between claudication onset time and self-reported symptom relief was good across treatment groups. This finding indicates that traditional objective treadmill test outcomes may not correlate well with symptom relief in patients with claudication. Future studies should investigate these data and improve understanding of patient relevance of traditional objective treadmill-based treatment outcomes.

We thank the readers for the interest in our article1 and for their insightful comments. One such reader, Dr Maylar, comments that the 6-month data from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) study do not justify a firm conclusion in favor of supervised exercise (SE). We note that the study was designed with a peak-walking-time, 6-month primary outcome end point; using this prespecified end point, SE provided a superior outcome to stent revascularization. However, high-quality comparative effectiveness research is always best designed to permit >1 clinical end point over relevant timeframes. In this context, we note that primary care and vascular specialty clinicians will evaluate both 6- and 18-month time points and the full range of outcomes achieved. As Dr Maylar points out, patient-centered outcomes were not as strongly positive for SE as the treadmill outcomes. The finding of more improvement in treadmill walking by SE participants but more symptom improvement in stent revascularization participants needs to be understood. We also agree that SE requires more commitment on the part of patients (but note that exercise would ideally be done …

Purpose The CLEVER Study (Claudication: Exercise Vs. Endoluminal Revascularization) previously reported superior treadmill peak walking time at 6 months when claudicants are treated with supervised exercise compared with stent revascularization. Conversely, it also showed better symptom improvement at 6 months for stent than supervised exercise. The purpose of this post-hoc analysis is to examine the relationship of disease-specific QOL (i.e., symptom) improvement with treadmill test outcomes, using data from CLEVER Study participants. Materials and Methods Multivariable regression analyses were done on treadmill test walking performance (peak walking performance and claudication onset time) using the 5 scales of the Peripheral Artery Questionnaire (PAQ) and Walking Impairment Questionnaire (WIQ), to examine the correlation and treatment group interaction effects. Results The correlation between change in symptoms and change in peak treadmill test walking performance showed a significant interaction effect with treatment group. Symptom improvement correlated with peak treadmill walking performance for those treated with stents but not for those treated with supervised exercise. There was a much larger improvement in symptoms for each minute of improvement in peak treadmill walking for stent compared with supervised exercise. In contrast, there was no significant treatment group interaction for claudication onset time on the treadmill, and improvements in symptoms correlated well with increases in claudication onset time, with no significant interaction with treatment group for any of the 5 scales. Conclusion Six month results from the CLEVER study show that although supervised exercise resulted in superior peak treadmill walking than stent revascularization, peak treadmill walking did not correlate with improved symptoms in that treatment group, whereas it did for the stent group. Treadmill claudication onset time may be a better endpoint for claudication treatment strategy trials, because symptom improvement and walking performance are both measured by it, independent of treatment group.