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

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 languge, 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.