Stents In Trial For Superficial Femoral Artery Disease

The Journal of Endovascular Therapy has established that the use of stents has improved management and outcomes of coronary artery disease, and clinical trials are now attempting to prove the same will be true for superficial femoral artery disease.
Randomized trials have shown favorable results for self-expanding nitinol stents compared with balloon angioplasty. A new report is seeking to test this treatment in a real-world population of patients enrolled in an observational registry.
The Journal of Endovascular Therapy offers a prospective multicentre observational study of patients with symptomatic superficial femoral artery stenosis. A total of 998 patients suffering from chronic limb ischemia were enrolled at 13 German medical centres. Twelve-month outcomes of the participants were assessed.
The median lesion length was 8 cm, but there was no restriction on the length of lesion to be treated. The authors cite this criterion as supporting the real-world aspect of the study population. Rather than including primarily high-risk patients, a general mix of patients participated in the study. However, a third of the patients had diabetes, and 43 percent were current smokers.
In all, 1,050 lesions were treated. Twelve months after surgery, target lesion revascularization—the primary endpoint of the study—was achieved in 136, or 17 percent, of the patients. Restenosis occurred in 24 percent of the patients and reocclusion in 10 percent. These results indicate that stent use is safe and is delivering favorable outcomes at the 1-year mark.
A commentary in the same issue asserts that the “real-world” study group is actually representative of a narrower set of patients, largely because the median lesion length was less than 10 cm—a length that has previously shown good success with intervention.
The author notes that, although the study validates that superficial femoral artery stenting is producing satisfactory patency results, patient quality of life and functionality measures might better represent success.
Full text of the article, “German Multicenter Real-World Registry of Stenting for Superficial Femoral Artery Disease: Clinical Results and Predictive Factors for Revascularization” from the Journal of Endovascular Therapy, Vol. 21, No. 4, 2014, are available online