Three recent randomized trials have assessed the benefits of endovascular therapy in patients with claudication. Briefly, the CLEVER trial (Claudication: Exercise Versus Endoluminal Revascularization Study), which randomized patients with aortoiliac disease to endovascular therapy, supervised exercise therapy (SET) or optimal medical therapy (OMT), demonstrated that both endovascular therapy and SET increased peak-walking time (PWT) at 18 months follow-up, while OMT did not. While both SET and endovascular therapy improved PWT in comparison to OMT, there was no significant difference in PWT between the SET and endovascular arms. The SET group demonstrated greater claudication onset time than the endovascular group. Conversely, the endovascular arm outperformed the SET arm in a variety of disease-specific quality of life metrics.
The ERASE (Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication) trial is currently the most useful and relevant of this set of trials for two reasons. First, ERASE included femoropopliteal disease in addition to aortoiliac disease. As femoropopliteal disease is the most common anatomic location of PAD in patients with intermittent claudication, the trial’s population more closely matches that of the real-world PAD population. Second, both treatment arms participated in supervised exercise. Given the recent CMS approval of supervised exercise therapy, the use of SET is expected to increase rapidly. Thus, by randomizing claudication patients with aortoiliac disease or femoropopliteal disease to either endovascular therapy plus SET or SET alone, the trial most closely modeled the current claudication population and randomized them to the most relevant treatment options. The combination group demonstrated a greater improvement in walking distance and health-related quality of life than SET alone. These data are useful in quantifying the differences in benefit between supervised exercise therapy alone compared with a combined intervention plus SET strategy (Figure 2).
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The IRONIC (Invasive Revascularization or Not in Intermittent Claudication) trial randomized patients with aortoiliac disease and femoropopliteal disease to either revascularization (both surgical and endovascular strategies were included) plus OMT or OMT alone (31). In this study, the OMT group performed home-based exercise. The revascularization group experienced a significant increase in walking distance compared to the OMT group (124-meter increase vs 50 m increase in the revascularization and OMT group, respectively).