Long-term clinical effectiveness of supervised exercise therapy versus endovascular revascularization for intermittent claudication from a randomized clinical trial

Background: Long-term comparisons of supervised exercise therapy (SET) and endovascular revascularization (ER) for patients with intermittent claudication are scarce. The long-term clinical effectiveness of SET and ER was assessed in patients from a randomized trial. Methods: Consenting patients with intermittent claudication were assigned randomly to either SET or ER. Outcome measures on functional performance (pain-free and maximum walking distance, ankle : brachial pressure index), quality of life (QoL) and number of secondary interventions were measured at baseline and after approximately 7 years of follow-up. Repeated-measurement and Kaplan-Meier methods were used to analyse the data on an intention-to treat-basis. Results: A total of 151 patients were randomized initially to either SET or ER. After 7 years, functional performance (P < 0.001) and QoL (P <= 0.005) had improved after both SET and ER. Long-term comparison showed no differences between the two treatments, except in the secondary intervention rate, which was significantly higher after SET (P = 0.001). Nevertheless, the total number of endovascular and surgical interventions (primary and secondary) remained higher after ER (P < 0.001). Conclusion: In the longer term, SET-first or ER-first treatment strategies were equally effective in improving functional performance and QoL in patients with intermittent claudication. The substantially higher number of invasive interventions in the ER-first group supports a SET-first treatment strategy for intermittent claudication. Registration number: NTR199 (http://www.trialregister.nl).