Additional Supervised Exercise Therapy After a Percutaneous Vascular Intervention for Peripheral Arterial Disease: A Randomized Clinical Trial

Abstract

Purpose To determine whether a percutaneous vascular intervention (PVI) combined with supplemental supervised exercise therapy (SET) is more effective than a PVI alone in improving walking ability in patients with symptomatic peripheral arterial disease (PAD). Materials and Methods In this prospective randomized trial, patients with PAD treated with a PVI were eligible. Exclusion criteria were major amputation or tissue loss, comorbidity preventing physical activity, insufficient knowledge of the Dutch language, no insurance for SET, and prior participation in a SET program. All patients received a PVI and subsequently were randomly assigned to either the PVI alone group (n = 35) or the PVI + SET group (n = 35). The primary outcome parameter was the absolute claudication distance (ACD). This trial was registered at Clinical trials.gov, NCT00497445. Results The study included 70 patients, most of whom were treated for an aortoiliac lesion. The mean difference in ACD at 6 months of follow-up was 271.3 m (95% confidence interval [CI] 64.0–478.6, P = .011) in favor of additional SET. In the PVI alone group, 1 (3.7%) patient finished the complete treadmill test compared with 11 (32.4%) patients in the PVI + SET group ( P = .005). Physical health–related quality-of-life score was 44.1 ± 7.8 in the PVI alone group compared with 41.9 ± 9.5 in the PVI + SET group, which was a nonsignificant difference ( P = .34). Conclusions SET following a PVI is more effective in increasing walking distance compared with a PVI alone. These data indicate that SET is a useful adjunct to a PVI for the treatment of PAD.