Abstract 13102: Long-term Clinical Effectiveness of Supervised Exercise Therapy versus Endovascular Revascularization for Intermittent Claudication: Results from a Randomized Controlled Trial
Background: Intermittent claudication (IC) is the most common presentation of peripheral arterial disease and is associated with significant functional disability and reduced quality-of-life (QoL). Supervised exercise therapy (SET) and endovascular revascularization (ER) are being recommended as first-line treatment for IC. However, to date only limited long-term studies comparing the two treatments have been reported. The objective of this study was to compare the long-term clinical effectiveness of SET versus ER as initial treatment for IC.
Methods: In a single center randomized controlled trial patients with IC were randomly assigned to receive either SET or ER. Outcome measures on functional capacity (pain-free and maximum walking distance, ankle brachial index) and QoL (rating score, short form-36, vascuQol) were measured at baseline, after 12 months and after a median long-term follow up of 78 months. Furthermore, the number of secondary interventions (ER or surgical) and overall survival were recorded. Repeated measurement techniques and Kaplan-Meier methods were used to analyze the data on an intention to treat basis.
Results: Between September 2002 and September 2005, 75 patients followed a 24-week SET program and 75 patients underwent an ER procedure. After 12 months the completeness of follow up was 100% in the SET group and 97% in the ER group, whereas after 78 months it decreased to 71% and 83%, respectively. After 12 and 78 months, functional capacity and QoL increased significantly compared to baseline in both the SET and the ER group. Moreover, no significant differences were found between the groups in the long term. The secondary intervention rate was significantly higher in the SET group compared to the ER group (hazard ratio: 2.0 (95% CI: 1.1 to 3.6); P=0.01). The overall survival was 77% in the SET group and 80% in the ER group (hazard ratio: 1.3 (95% CI: 0.7 to 2.7); P=0.40).
Conclusions: In the long term SET and ER are equally effective in improving functional capacity and QoL in patients with IC. In spite of a higher secondary intervention rate after SET, these data support the use of SET as a first-line treatment in the care of patients with IC.
- © 2012 by American Heart Association, Inc.