Long-term outcomes of a randomized clinical trial of supervised exercise, percutaneous transluminal angioplasty or combined treatment for patients with intermittent claudication due to femoropopliteal disease

Background: To compare the long-term outcomes of angioplasty (PTA), supervised exercise (SEP) and combined treatment (PTA+SEP) in patients with intermittent claudication (IC) due to femoropopliteal disease. Methods: Patients recruited to PTA, SEP and PTA+SEP arms of RCT were invited for long-term follow-up from 2010 to 2011.Indicators of limb ischaemia were recorded (ankle-brachial pressure indices, treadmill walking distances (ICD, MWD, PRWD). Duplex ultrasound was also performed. Patients completed SF36 and Vascuqol quality of life(QOL) questionnaires. Results: Of the 178 patients recruited in the trial, 139 were alive at the time of follow-up (PTA=46, SEP=47, PTA+SEP=46). Assessments were completed for 111 patients. Median time to follow-up was 5.2years (IQR 3.8-7.4years). Median age of patients at follow up was 75years. 62.2%(N=69) of patients were symptomatic.16.2%(N= 18) had experienced major cardiovascular event since their last follow-up visit. Intra-group analysis: Improvement was observed in ankle brachial pressure index (ABPI) in all groups. QOL outcomes were inconsistent across individual groups. Inter-group analysis: PTA and PTA+SEP groups demonstrated a significantly higher ABPI as compared to SEP group. No significant difference was observed in walking distances, QOL outcomes, restenosis rates, and new ipsilateral and contralateral lesions on duplex scan. Patients required re-interventions in all group (PTA=14, SEP=10, PTA+SEP=6). Number of re-interventions was higher in PTA group(N=29) as compared to SEP(N=17) and PTA+SEP(N=9) but failed to reach statistical significance. Conclusion: PTA, SEP and combined treatment are equally effective long-term treatment options for patients with femoropopliteal claudication. Addition of SEP to PTA can reduce the symptomatic restenosis and re-intervention rates