Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery

Abstract

Background: The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable nitinol stent in the superficial femoral artery (SFA).

Methods: This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful nitinol stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group.

Results: The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P < .0001 and P < .0001, respectively). Overall survival rates were 96.8%, 89.5%, and 81.8% in the low-risk group; 91.5%, 74.4%, and 68.7% in the moderate-risk group; and 78.2%, 63.2%, and 48.7% in the high-risk group at 1, 3, and 5 years, respectively. There were also significant differences in mortality (P < .0001).

Conclusions: New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable nitinol stenting for SFA disease.