PAD Patients Do Better When Endovascular Therapy Added to Exercise Program
Patients with PAD and intermittent claudication who receive endovascular therapy before embarking on a 12-month supervised exercise program have better function and QoL compared with those who skip that step and receive exercise alone, reports a Dutch RCT. Just how those results should be interpreted and applied in the US remains open, however, since PAD exercise programs are typically unavailable or not reimbursed.
The findings were published in the November 10, 2015, issue of JAMA.
For the Endovascular Revascularization And Supervised Exercise (ERASE) trial, M.G. Myriam Hunink, MD, PhD, of Erasmus University Medical Center (Rotterdam, the Netherlands), and colleagues allocated 212 patients (mean age 65 years; 62% men) to supervised exercise alone or with the addition of endovascular revascularization (with selective stenting).
Within the combination therapy group, the index revascularization was successful in 96% of cases, with balloon angioplasty accompanied by selective stenting in 62%. Procedure-related minor complications included groin hematoma (5 cases) and localized arterial dissection (2 cases) but there were no major complications reported. Patients in whom the revascularization failed either received open surgery (n = 3) or supervised exercise (n = 1).
On average, patients assigned to endovascular therapy completed 30 exercise sessions during 1-year follow-up, compared with 43 sessions in the exercise-alone group. The recommended number of sessions was 46 to 59.
Both the combination therapy group and the exercise-alone group saw gains in functional performance. The primary endpoint of mean difference in maximum walking distance at 12 months favored the combined strategy. However, the greatest between-group difference was observed at 1 month, with the initial disparity diminishing over time (table 1).
Other performance measures including mean values for pain-free walking distance, ankle brachial index (ABI) at rest, and ABI after exercise each showed superiority for endovascular revascularization. Patients receiving the combo therapy also had better improvement in the disease-specific VascuQol score (mean difference 0.62) and the SF-36 physical functioning score than did those assigned to supervised exercise (mean difference 9.8; P < .001 for both). There were no between-group difference seen for the SF-36 domains of physical role functioning, bodily pain, and general health perceptions.
Among the 70 endovascular therapy patients with duplex ultrasonography follow-up at 1 year, 32% had significant restenosis (74% femoropopliteal and 26% aortoiliac). Secondary revascularization due to deterioration of claudication was needed in 17% of those with restenosis.
According to the study authors, ERASE is the first adequately powered RCT to answer the question of whether endovascular therapy can augment the benefit of supervised exercise in this population. The CLEVER trial, they note, prematurely stopped enrolling patients in its endovascular plus exercise arm due to slow recruitment, as did the MIMIC trial.
“The present study reopens the debate for revascularization in patients with claudication,” particularly regarding an endovascular-first approach, Hunink et al write. Forthcoming data will “address the question of whether the incremental benefit of the combination therapy as demonstrated in this study will also be cost-effective given the substantially higher costs of endovascular revascularization compared with supervised exercise.”
Reimbursement, Availability Issues
MIMIC investigator Timothy P. Murphy, MD, of Rhode Island Hospital (Providence, RI), said that due to lack of reimbursement and unavailability of exercise programs in the United States, the default mode for treating patients with claudication here is endovascular therapy.
“The people getting managed with the extensive invasive therapy, however, actually aren’t getting everything that they could,” he told TCTMD in an interview. “With just a little bit more investment in an exercise rehab program, they would get a substantial boost to their performance.”
Some centers use “workarounds” such as having patients pay out of pocket or coding the condition under coronary or pulmonary rehab, Murphy noted. “But in general, you couldn’t get the supervised exercise component if you wanted it, whereas you can get the angioplasty or stenting component.”
JAMA Senior Editor Mary McGrae McDermott, MD, of Northwestern University Feinberg School of Medicine (Chicago Illinois), points out that pentoxifylline and cilostazol are the only FDA-approved drugs for treating walking difficulties related to PAD. Beyond barriers related to insurance, “traveling to a center 3 times weekly for supervised exercise can be burdensome,” she notes in an accompanying editorial.
As a result, she reports, the number of endovascular procedures done in the United States for intermittent claudication quadrupled between 1999 and 2007.
“Results of the ERASE trial should not be construed as evidence supporting further increases in rates of lower extremity revascularization,” she cautions, citing the limited durability of endovascular procedures and “potential adverse downstream consequences” associated with the risks of repeat treatment.
While underscoring the known benefits of supervised exercise for PAD, the study “newly demonstrates that supervised exercise also improves lower extremity outcomes after endovascular revascularization,” McDermott concludes.
Indeed, Murphy said, “Since exercise is not that expensive compared to invasive procedures and it entails little risk, I think it’s kind of a no brainer” that exercise should be available to these patients.
1. Fakhry F, Spronk S, van der Laan L, et al. Endovascular revascularization and supervised exercise for peripheral artery disease and intermittent claudication: a randomized clinical trial. JAMA. 2015;314:1936-1944.
2. McDermott MM. Erasing disability in peripheral artery disease: the role of endovascular procedures and supervised exercise [editorial]. JAMA. 2015;314:1921-1923.
- The study was funded by the Netherlands Organisation for Health Research and Development. Hunink reports receiving personal fees from Cambridge University Press, grants and nonfinancial support from the European Society of Radiology, and nonfinancial support from the European Institute for Biomedical Imaging Research.
- McDermott reports that until 2014 she was a medical editor for the Foundation for Informed Medical Decision Making and received an honorarium from Healthwise. She also has received grant funding from the NIH, Novartis, and the Patient-Centered Outcomes Research Institute.
- Murphy reports no relevant conflicts of interest.