Combination of Treatment for PAD Yielded Better Results

Dallas—Patients with peripheral arterial disease (PAD) and intermittent claudication who underwent endovascular revascularization and supervised exercise therapy had a significant improvement in walking distance and quality of life compared with a group that had the standard treatment of supervised exercise alone, according to a randomized trial.

Farzin Fakhry, MSc, lead author of the study, presented the results at the AHA Scientific Sessions during a late-breaking abstract session. He noted that the researchers are also analyzing the cost-effectiveness of endovascular revascularization and supervised exercise therapy, although they did not have preliminary or final results to present at the meeting.

After 12 months, patients in the combination group could walk a mean of 282 meters longer than the exercise alone group (P=.001). The difference was also found at 1 month (566 meters longer in the combination group; P<.001) and at 6 months (409 meters longer in the combination group; P<.001). The difference in the mean pain-free walking distance also favored the combination group at 1 month (543 meters difference; P<.001), at 6 months (529 meters difference; P<.001), and at 12 months (408 meters difference; P<.001).

The combination group also had a significant improvement in disease-specific vascular quality of life at 1-, 6-, and 12-months as well as in the Short Form-36 (SF-36) physical functioning measure. However, at 12 months, there was no difference in the groups on the SF-36 physical role functioning, bodily pain, and general health measures.

Dr. Fakhry said PAD causes “significant morbidity and mortality worldwide” and affects more than 8 million people in the United States. Patients with intermittent claudication, a symptomatic form of PAD, have severe functional and quality of life limitations because of their impaired walking distance, according to Dr. Fakhry. He added that previous trials found that supervised exercise and endovascular revascularization alone were equally effective in these patients but have different working mechanisms.

The authors of the ERASE (Endovascular Revascularization and Supervised Exercise) trial wanted to examine the combination of the 2 treatment options. They enrolled 212 patients enrolled at 10 sites in the Netherlands were randomized to receive endovascular revascularization plus supervised exercise therapy or exercise alone. The groups were well balanced with an average age of approximately 65 years. More than 90% of patients were a current or former smoker.

Patients were included if they had stable intermittent claudication for at least 3 months, had an aortoiliac and/or femoropopliteal stenosis or occlusion, had a target lesion suitable for endovascular revascularization, had no prior treatment, and could follow exercise therapy.

The endovascular revascularization consisted of balloon angioplasty with selective stenting, while trained physical therapists supervised exercise sessions that lasted approximately 1 hour apiece and consisted of mainly walking on a treadmill. Patients had 2 to 3 sessions per week in the first 3 months, 1 to 2 sessions per week from months 3 to 6, and 1 session per week from months 6 to 12. The schedule depended on patients’ progress and preference.

After a year, 94% of patients in the combination group and 92% of patients in the exercise alone group completed the study. There were 3 deaths in the exercise group and 1 death in the combination group. Of the patients in the combination group, 96% had a successful endovascular procedure and 62% of them were stented.

Further, following a year of treatment, 92% of patients in the combination group and 77% of patients in the exercise alone group did not need a secondary intervention such as an endovascular or open revascularization.