ERASE: EVR plus exercise bests exercise alone in patients with intermittent claudication

Issue: January 2014

DALLAS — Patients with peripheral artery disease and intermittent claudication who were treated with endovascular revascularization plus exercise had greater improvements in quality of life and pain-free and maximum walking distance at 12 months when compared with the standard therapy of exercise alone.

Perspective from Mark A. Creager, MD, FACC

According to ERASE investigator Farzin Fakhry, MSc, with Erasmus Medical Center, Rotterdam, The Netherlands, intermittent claudication is the most common symptomatic form of PAD.

“About 10% to 20% of patients with PAD experience intermittent claudication. They have limited functional performance and quality of life which is comparable to other CVDs,” Fakhry said at a press conference at AHA 2013.

This led Fakrhy and fellow investigators to initiate the multicenter, randomized controlled trial, which was conducted at 10 sites in The Netherlands. According to Fakhry, the study aimed to compare the clinical effectiveness of endovascular revascularization (EVR) plus supervised exercise therapy (SET) vs. the standard care of SET only in patients with intermittent claudication.

The investigators randomly assigned 212 patients with stable intermittent claudication for more than 3 months to receive either a combination therapy of endovascular revascularization (EVR) plus standard exercise therapy (SET; n=106) or SET only (n=106).

Researchers recorded functional performance measures, including pain-free and maximum walking distance, during a graded treadmill test, and assessed patient reported health-related quality of life with the VascuQol questionnaire and Short-Form 36 Health Survey (SF-36).

At 12 months, follow-up was complete in 94% of patients in the combination therapy group and 92% in the SET group. Compared with SET alone, the combination therapy group experienced a greater improvement in maximum walking distance (+282 meters; 99% CI, 60-505; P=.001) and pain-free walking distance (+408 meters; 99% CI, 195- 622; P<.001).

Results from the disease-specific VascuQol questionnaire indicated greater improvement in the combination therapy group (+0.62; 99% CI, 0.20-1.03; P<.001) compared with SET. Similarly, patients had a greater improvement with physical functioning, as assessed by the SF-36 scale, in the combination therapy group (P=.002).

“In patients with intermittent claudication, a combination therapy of endovascular revascularization followed by supervised exercise therapy resulted in significant greater improvements in functional performance and quality of life compared to the standard care of supervised exercise therapy only,” Fakhry concluded. – by Brian Ellis

For more information:

Fakhry F. LBCT.04. Therapeutic advances in coronary and peripheral vascular disease. Presented at: the American Heart Association Scientific Sessions; Nov. 16-20, 2013; Dallas.

Disclosure: Fakhry reports no relevant financial disclosures.

Perspective

Mark A. Creager, MD, FACC

ERASE was a well-conducted trial. It extends observations made in other recent trials, including CLEVER, which compared supervised exercise training to endovascular intervention in patients with PAD, intermittent claudication and iliac artery stenosis. In CLEVER, both treatments were better than optimal medical therapy after 6 months. The supervised exercise training group did somewhat better in terms of patients’ walking time than endovascular intervention. The strategy of the ERASE trial was to combine those two treatments and compare the efficacy of both vs. supervised exercise training alone. Patients in the combination therapy group did substantially better and their quality of life improved compared with the patients treated just with exercise training. This is an important and novel finding, which may impact physician’s treatment of patients with intermittent claudication. Encouraging findings such as these, however, need to be reproduced before they enter into standard clinical practice. Importantly, they reinforce the need to offer exercise training on top of any interventions we may undertake to improve symptoms in patients with PAD. We need to stress to our patients that they be committed to exercise, and third party payers, such as CMS, should modify their reimbursement policies to enourage the appropriate use of exercise training for patients with symptomatic PAD.

Mark A. Creager, MD, FACC

Professor of Medicine and Director, Vascular Center

Brigham and Women’s Hospital, Boston

Disclosures: Creager reports consulting for companies that are doing research in PAD, including AstraZeneca, but none that are doing exercise training or implanting a stent.