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Are you treating patients in your emergency department (ED) with peripheral artery disease (PAD) or critical limb ischemia (CLI)? With nearly 30 million people affected each year by these conditions, EDs are being inundated with patients presenting with blocked arteries to their extremities, with the most common presentation being pain and ulcers, with or without gangrene in the legs.
Previous research has shown amputation rates in these patients to be as high as 40% in the year following their diagnosis, with mortality rates approaching 20%. In response to these numbers, a multi-center XpertTM nitinol stenting for Critically IschEmic Lower Limbs (XCELL) trial set out to evaluate the safety and effectiveness of a new procedure, percutaneous transluminal angioplasty, for improving CLI outcomes with stenting of the infrapopliteal arteries.
The self-expanding stent was evaluated in 120 CLI patients with infrapopliteal lesions of 4-15 cm in length. A total of 140 limbs and 212 implanted devices were included in the study, with the primary endpoint being 12-month amputation-free survival (AFS) and secondary endpoints being limb salvage, wound healing, and pain relief.
The trial results, which were published in a recent issue of Catheterization and Cardiovascular Interventions, revealed that 12-month AFS was 78%. Further analysis confirmed that according to baseline Rutherford classes 4, 5, and 6, the 12-month AFS rates were 100%, 77%, 55%, respectively; freedom from major amputation were 100%, 91% and 70%, respectively. The investigators also determined that the 12-month freedom from major amputation rate and clinically driven target lesion revascularization were 90% and 70%, respectively. Six-month and 12-month wound-healing rates were 49% and 54%, respectively.
“With the obesity epidemic, we expect the incidence of diabetes to rise as well, and as these patients age, this could sharply increase rates of CLI,” explains Dr. Krishna J. Rocha-Singh, MD, FSCAI, Prairie Education & Research Cooperative in Springfield, Ill, and lead researcher in the XCELL trial. “It is essential that we identify less invasive treatment strategies that are safe and effective in improving vascular disease.” Moreover, studies show that a 25% reduction in amputations could save $29 billion in health care costs, according to the Sage Group.