This study evaluated distinct strategies of care in three treatment groups: (i) optimal medical care (OMC), (ii) supervised exercise rehabilitation (SE), and (iii) stent revascularization (ST). A fourth treatment group that combined ST and SE was dropped after enrolling 8 participants upon the recommendation of the Data Safety and Monitoring Board (DSMB) in order to enhance enrollment in treatment groups that were part of the primary endpoint. Randomization was performed using a real-time web-based randomization system in a 2:2:1 ratio (ST:SE:OMC) (half as many enrolled in OMC because the treatment effect between the other groups and OMC was assumed to be much larger than between SE and ST). Randomization was stratified by geographic region and cilostazol use at baseline.
Optimal medical care was established via active promotion of the standards established by the intersocietal 2005 ACC-AHA Guidelines for the Management of Patients with Peripheral Artery Disease in order to promote best practices for risk factor management; use of antiplatelet therapy; and use of claudication pharmacotherapy. All study participants received cilostazol (Pletal™, Otsuka America, Inc., San Francisco, CA) 100 mg by mouth twice daily as tolerated. In addition, OMC included advice about the use of home exercise and diet in the form of standardized verbal instructions as well as printed material (Krames Staywell, San Bruno, CA). Cardiovascular risk factor data were collected and feedback provided to the sites by a central risk factor committee. Risk factors were then managed directly by the local study site.
Supervised exercise consisted of 26 weeks of exercise, three times a week, for an hour at a time. Sites were trained to provide SE using a common protocol and progress of each participant was monitored by an oversight committee (23 (link)).
Stent revascularization was done to relieve all hemodynamically significant stenoses (>50% by diameter) in the aorta and iliac arteries using FDA-approved self-expanding or balloon-expandable stents. The protocol allowed for femoropopliteal endovascular revascularization to treat any additional focal lesions, but this was not done for any study participant. Intra- or post-procedure oral antiplatelet medication use was at the discretion of the operator.
Optimal medical care was established via active promotion of the standards established by the intersocietal 2005 ACC-AHA Guidelines for the Management of Patients with Peripheral Artery Disease in order to promote best practices for risk factor management; use of antiplatelet therapy; and use of claudication pharmacotherapy. All study participants received cilostazol (Pletal™, Otsuka America, Inc., San Francisco, CA) 100 mg by mouth twice daily as tolerated. In addition, OMC included advice about the use of home exercise and diet in the form of standardized verbal instructions as well as printed material (Krames Staywell, San Bruno, CA). Cardiovascular risk factor data were collected and feedback provided to the sites by a central risk factor committee. Risk factors were then managed directly by the local study site.
Supervised exercise consisted of 26 weeks of exercise, three times a week, for an hour at a time. Sites were trained to provide SE using a common protocol and progress of each participant was monitored by an oversight committee (23 (link)).
Stent revascularization was done to relieve all hemodynamically significant stenoses (>50% by diameter) in the aorta and iliac arteries using FDA-approved self-expanding or balloon-expandable stents. The protocol allowed for femoropopliteal endovascular revascularization to treat any additional focal lesions, but this was not done for any study participant. Intra- or post-procedure oral antiplatelet medication use was at the discretion of the operator.
