XCELL Data Support Infrapopliteal Use of Abbott's Xpert Stent in Patients With CLI

July 24, 2012—Krishna J. Rocha-Singh, MD, et al published findings from the XCELL trial, an evaluation of the safety and effectiveness of the Xpert self-expanding nitinol stent (Abbott Vascular, Santa Clara, CA) in Rutherford class 4 to 6 patients with infrapopliteal lesions that are 4 to 15 cm in length. The investigators noted in the background of the study that percutaneous transluminal angioplasty with stent deployment in infrapopliteal arteries is an accepted but unproven therapy for patients with critical limb ischemia (CLI). The study is available online ahead of print in Catheterization and Cardiovascular Interventions.

In a press release issued by the Society for Cardiovascular Angiography and Interventions (SCAI), Dr. Rocha-Singh commented, “With the obesity epidemic, we expect the incidence of diabetes to rise, and as these patients age, this could sharply increase rates of CLI. It is essential that we identify less-invasive treatment strategies that are safe and effective in improving vascular disease.” He added, “Our XCELL trial findings confirm that infrapopliteal nitinol stenting is safe and effective in treating CLI patients. While there were a few major adverse events, such as death, heart attack, or major amputation that occurred in the first 30 days, at the first year postprocedure, limb preservation, wound healing, and pain relief rates were excellent.”

As summarized in Catheterization and Cardiovascular Interventions, the XCELL study is composed of 120 patients (140 limbs, 212 implanted devices) who underwent primary infrapopliteal nitinol stent implantation as part of this multicenter registry. The primary endpoint was 12-month amputation-free survival (AFS), and secondary endpoints included limb salvage, target lesion revascularization (TLR), 6-month angiographic patency, and 6- and 12-month outcomes of wound healing and pain relief.

The investigators reported that despite a 6-month binary stent restenosis rate of 68.5%, the 12-month AFS rate was 78.3%. Stratified according to baseline Rutherford classes 4, 5, and 6, the 12-month AFS rates were 100%, 77.3%, and 55.2%, respectively, and freedom from major amputation rates were 100%, 90.9%, and 70.1%, respectively. The 12-month freedom from major amputation and clinically driven TLR rates were 89.6% and 70.1%, respectively. The 6- and 12-month complete wound healing rates were 49% and 54.4%, respectively. Rutherford class 4 patients had significant pain relief through 12 months (P < .05).

These data demonstrated that primary infrapopliteal nitinol stenting to treat CLI is safe and effective in improving 6- and 12-month clinical outcomes, concluded the XCELL investigators.