Abstract 10576: Long-term Outcomes and Risk Stratification of Patency and Overall Survival Following Nitinol Stenting in the Femoropopliteal Disease With Critical Limb Ischemia
Background: The purpose is to investigate the long-term outcomes of nitinol stenting in femoropopliteal (FP) lesions with critical limb ischemia (CLI) and to determine the factors associated with primary patency and overall survival.
Methods: This study was a multicenter retrospective study. From January 2004 to December 2011, 598 consecutive patients (865 limbs; 74.4 ± 10.3 years; 61.5% male) who underwent successful FP stenting with self-expandable nitinol stents for de novo lesions, CLI were retrospectively selected and analyzed. Stent patency was assessed by either duplex or angiography and analyzed by Kaplan-Meier estimation. The determinants of restenosis were explored with Cox proportional hazard regression analyses. Risk stratification of primary patency (PP) and overall survival (OS) were subsequently analyzed using a score based on the significant prognostic factors identified in the multivariate model.
Results: 39% were on hemodialysis (HD). The mean follow-up period was 19.1 ± 17.2 months. At 1, 3, and 5 years the PP rates were 77.0%, 59%, and 46.7%; secondary patency (SP) were 93.9%, 87.9%, and 80.3%; OS were 83.4%, 63.1%, and 49.6%; amputation free survival (AFS) were 78.5%, 59.9%, 46.7%; limb salvage (LS) were 93.3%, 90.8%, 90.8%, respectively. Multivariate Cox regression analysis identified female gender (HR 1.4; P = .048), BMI (HR, 1.05; P = .04), cilostazol administration (HR, 0.63; P =.005), and TASC II class C/D (HR, 1.67; P = .007) as strong independent factors associated with PP. Besides, age (HR 1.05; P = .0002), HD (HR, 1.98; P = .019), hemoglobin (HR,0.85; P = .028), ambulatory status (HR, 0.46; P = .003) as strong independent factors associated with overall survival.
After assigning a risk score based on the outcomes of the multivariate regression analysis (overall survival 1 each for age > 75, HD, hemoglobin < 10, non-ambulatory status), OS was found to be lower in patients with a higher cumulative score (5 years overall survival rate: score 0: 91%, score 1: 45%, score 2: 39%, score 3: 28%, respectively; P < 0.05)
Conclusions: Endovascular therapy using nitinol stents for FP lesions with CLI yielded acceptable outcomes. Risk stratification for overall survival may play an important role for strategy in FP lesions with CLI.
- © 2013 by American Heart Association, Inc.