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Endoluminal bypass shows promise for PAD
In a small randomized controlled study, endoluminal bypass with heparin-bonded covered stents demonstrated several advantages over conventional femoropopliteal surgery in patients with long occlusive lesions in the superficial femoral artery.
At 30 days after the procedure, patients who underwent endoluminal bypass vs. surgery had fewer complications (25 vs. 61; P = .048) and shorter hospital stay (3.7 days vs. 6 days; P = .002), as well as no significant differences between groups in the number of serious adverse events.
Although quality of life, as measured by SF-36, was better with endoluminal bypass vs. surgery at 1 week (50.2 vs. 37.1; P = .011), the difference was no longer significant by 1 year. Walking Impairment Questionnaire scores, which were used to assess disease-specific health status in patients with intermittent claudication, were also improved in both groups at 1 year, but those in the endoluminal bypass group experienced earlier improvements.
Additionally, at 1 year, the researchers found no differences between the endoluminal bypass and surgery groups in primary patency (64.8% vs. 63.6%), assisted primary patency (78.1% vs. 79.8%), secondary patency (85.9% vs. 83.3%) and target vessel revascularization (72.1% vs. 71%). Both groups achieved a limb salvage rate of 100%, according to the data.
Rutherford category did not differ significantly between groups at any time point, with both groups experiencing significant improvement from baseline to 1 year.
The trial included 129 patients recruited from six centers in the Netherlands. Of these patients, 125 were randomly assigned to endoluminal bypass or surgery. A low enrollment rate prompted the researchers to stop enrollment before reaching the target number for patency, deeming that the inclusion period would become too long.
In an accompanying editorial published in JACC: Cardiovascular Interventions, Michael R. Jaff, DO, president of Newton-Wellesley Hospital in Newton, Massachusetts, professor of medicine at Harvard Medical School and a Cardiology Today’s Intervention Editorial Board Member, noted certain aspects of the study, particularly the “randomization fatigue” that plagues most randomized peripheral artery disease trials, preclude wider applicability of these results.
“As clinician investigators who struggle with optimal therapy for patients with PAD, and specifically for those with the most advanced manifestations of the disease (limb-threatening ischemia), we must recommit to forestalling randomization fatigue and finish the battle on behalf of our patients,” he wrote. – by Melissa Foster
Disclosures: The study was partly supported by W.L. Gore and Associates. Four researchers report they have received speaker fees from W.L. Gore and Associates. Jaff reports he has served as a noncompensated adviser to Abbott Vascular, Boston Scientific, Medtronic Vascular and Cordis; he has served as a consultant for Micell, Philips-Volcano, Vactronix, Venarum and the American Orthotics and Prosthetics Association; he owns equity in Embolitech, PQ Bypass and Vascular Therapies; and he has served as a member of the Executive Committee for the NIH BEST-CLI trial.