(HealthDay News) – For patients with critical limb ischemia (CLI), use of infrapopliteal nitinol stenting (Xpert self-expanding nitinol stent) is safe and improves clinical outcomes at six and 12 months, according to a study published online July 24 in Catheterization & Cardiovascular Interventions.
Krishna J Rocha-Singh, MD, from St John’s Hospital in Springfield, IL, and colleagues examined the safety and effectiveness of the Xpert self-expanding nitinol stent using data from 120 Rutherford Class 4–6 patients (140 limbs; 212 implanted devices), who underwent primary infrapopliteal nitinol stent deployment.
The researchers found that the 12-month amputation-free survival (AFS) rate was 78.3%, despite a six-month binary stent restenosis rate of 68.5%. The 12-month AFS rates were 100%, 77.3%, and 55.2%, respectively, for Rutherford classes 4, 5, and 6, and the corresponding freedom from major amputation rates were 100%, 90.9%, and 70.1%. The 12-month freedom from major amputation rate was 89.6% and the rate of clinically driven target lesion revascularization was 70.1%. The complete wound-healing rates were 49% at six months and 54.4% at 12 months. There was significant pain relief through 12 months for Rutherford class 4 patients.
“Primary infrapopliteal nitinol stenting to treat CLI is safe and effective in improving six-and 12-month clinical outcomes,” the authors conclude.
Several authors disclosed financial ties to Abbott Vascular, which funded the study and manufactures the Xpert self-expanding nitinol stent.