Endovascular Revascularization And Supervised Exercise for claudication - ERASE

Nov 18, 2013
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Netherlands Organization for Health Research and Development
Date Presented:
01/01/2013
Date Updated:
11/18/2013
Original Posted Date:
11/18/2013
References

Description:

The goal of the trial was to evaluate a strategy of endovascular revascularization plus supervised exercise training compared with supervised exercise training alone among patients with intermittent claudication.

Hypothesis:

Endovascular revascularization and supervised exercise training will improve maximum walking distance.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients with intermittent claudication of at 3 months’ duration due to aortoiliac or femoropopliteal disease

    Number of enrollees: 212 patients
    Duration of follow-up: 12 months
    Mean patient age: 67 years
    Percentage female: 33%

Primary Endpoints:

  • Maximum walking distance on a graded treadmill test

Secondary Endpoints:

  • Pain-free walking distance
  • Ankle-brachial index at rest and after walking
  • Quality of life
  • Leg amputations and secondary interventions

Drug/Procedures Used:

Patients with intermittent claudication were randomized to endovascular revascularization plus supervised exercise training (n = 106) versus supervised exercise training alone (n = 106).

Principal Findings:

Overall, 212 patients were randomized. The mean age was 66 years, 33% were women, 92% were current/former smokers, 63% had hypertension, 26% had diabetes, and mean body mass index was 26 kg/m2.

Compared with supervised exercise training alone, the maximum walking distance was improved by combination with endovascular revascularization; 566 m at 1 month (p < 0.001 between groups), 409 m at 6 months (p < 0.001 between groups), and 282 m at 12 months (p = 0.001 between groups).

Compared with supervised exercise training alone, the pain-free walking distance was improved by combination with endovascular revascularization; 543 m at 1 month (p < 0.001 between groups), 529 m at 6 months (p < 0.001 between groups), and 408 m at 12 months (p < 0.001 between groups).

Endovascular revascularization plus supervised exercise training was also associated with improvements in quality of life compared with supervised exercise training alone.

Interpretation:

Among patients with intermittent claudication, endovascular revascularization plus supervised exercise training was associated with improvements in maximum walking distance, maximum pain-free walking distance, and quality of life. Endovascular revascularization versus exercise training resulted in an early improvement in maximum walking distance (i.e., at 1 month); however, this benefit, while still present, diminished later in follow-up (i.e., at 6 and 12 months).

References:

Presented by Dr. Farzin Fakhry at the American Heart Association Scientific Sessions, Dallas, TX, November 18, 2013.

Keywords: Intermittent Claudication, Walking, Body Mass Index, Quality of Life, Exercise Therapy, Pain, Hypertension, Diabetes Mellitus


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