Transluminal Angioplasty Stenting Improves Blood Flow in Extremities

A new study suggests that patients with critical limb ischemia (CLI) may find relief through a previously unproven therapy, infrapopliteal artery stent implantation.

Researchers at the Prairie Education & Research Cooperative (Springfield, IL, USA) conducted a study that followed 120 patients who underwent primary infrapopliteal nickel-titanium (nitinol) stent deployment via percutaneous transluminal angioplasty (PTA) as part of the multicenter Xpert Nitinol Stenting for Critically IschEmic Lower Limbs (XCELL) trial. The trial evaluated the safety and effectiveness of the Xpert self-expanding nitinol stent, a product of Abbott Vascular (Redwood City, CA, USA).


In all, 140 limbs in the 120 Rutherford Class 4-6 subjects with infrapopliteal lesions of 4-15 cm in length were treated with 212 implanted devices. The primary endpoint was 12-month amputation-free survival (AFS); 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 results showed that despite a 6-month binary stent restenosis rate of 68.5%, the average 12-month AFS rate was 78.3%. The 12-month freedom from major amputation rate and clinically driven TLR were 89.6% and 70.1%, respectively, and the 6- and 12-month complete wound-healing rates were 49.0% and 54.4%, respectively. Rutherford class 4 patients had significant pain relief through 12-months. The study was published ahead of print on May 17, 2012, in Catheterization and Cardiovascular Interventions.

“Our XCELL trial findings confirm that infrapopliteal nitinol stenting is safe and effective in treating CLI patients,” concluded lead author Krishna Rocha-Singh, MD, and colleagues. “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.”

CLI affects close to 30 million people in Europe and North America, with most experiencing pain and ulcers with or without gangrene in the legs. Previous research shows amputation rates are as high as 40% in CLI patients in the first year following their diagnosis, with mortality rates approaching 20%. Moreover, an estimated 160,000 amputations due to peripheral artery disease (PAD) are performed each year in the United States alone, of which a 25% reduction could save almost USD 30 billion in health care costs.

Related Links:
Prairie Education & Research Cooperative
Abbott Vascular