Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years

Abstract

ObjectivePrimary stenting is a well-established treatment option for femoropopliteal arterial disease. However, there is a paucity of data concerning the performance of this modality at ≥5 years. This study evaluated the long-term clinical and radiologic outcomes of primary stent therapy in patients with femoropopliteal arterial disease. MethodsA prospective data collection and analysis was conducted in patients undergoing primary stent placement in femoropopliteal lesions between September 2006 and September 2007. The EverFlex (Medtronic/Covidien, Plymouth, Minn) bare-metal stent was used. The primary outcome of this study was the primary patency rate. Secondary outcomes were secondary patency rate, amputation-free-survival (AFS), and freedom from target lesion revascularization (TLR). A Cox regression analysis identified risk factors for the primary and the secondary measure outcomes. ResultsIncluded were 89 patients (102 stents). The prevalence of critical limb ischemia was 34% (n = 30). The initial angiography revealed a TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D lesion in 31 patients (35%). Occlusions were present in 49 patients (55%), and the mean lesion length was 116 ± 33 mm. Popliteal artery disease was present in 39 treated limbs (35%). The primary patency rate at 1, 3, 5, and 7 years was 73%, 64%, 47%, and 33% respectively. At 7 years, secondary patency rate was 67%, freedom from TLR was 47%, and the AFS was 73%. Cox regression analysis revealed a decreased AFS among diabetic patients (hazard ratio [HR], 2.6; 95% confidence interval [CI], 1.08-6.28; P = .03), whereas secondary endovascular interventions showed a protective effect for AFS (HR, 0.14; 95% CI, 0.03-0.65; P = .01). Popliteal artery disease was identified as independent risk factor for secondary interventions (HR, 2.07; 95% CI, 1.05-4.06; P = .04) and TLR (HR, 1.99; 95% CI, 1.03-3.83; P = .04). Critical limb ischemia was associated with an increased incidence of surgical conversion owing to endovascular treatment failure (HR, 5.46; 95% CI, 2.44-12.17; P < .001). ConclusionsThis study found primary stenting was associated with acceptable clinical and radiologic long-term outcomes. Diabetes was associated with poor AFS, and popliteal artery involvement correlated with an increased need for reinterventions. AFS was better among patients undergoing secondary procedures.