The optimal diameter of a self-expandable stent for femoropopliteal (FP) artery disease remains unclear. The aim of this study is to investigate the influence of stent diameter on the clinical outcome after FP stenting and to identify optimal stent diameter of self-expandable stent implantation. This study was a prospective observational study. Eighty patients who underwent successful self-expandable stent implantation for FP disease were enrolled in this study. A commercially available self-expandable stent was used. The operator determined the type, diameter and length of the stent based on a visual estimate in angiography. A peak systolic velocity ratio >2.0 was defined as restenosis. Primary patency was defined as treated vessel without restenosis and repeat revascularization. Secondary patency was defined as target vessel which subsequently become totally occluded and is reopened by repeat revascularization. As a result, restenosis was found in 34 patients (42.5%) during the follow-up of 24 months. In-stent restenosis was independently predicted by stent fracture [hazard ratio (HR) 2.6, p = 0.01], chronic total occlusion (HR 2.4, p = 0.02) and stent diameter ×10/vessel diameter (S/V) ratio (HR 1.7, p = 0.04). Using receiver-operator characteristic analysis, S/V ratio >1.30 best separated patients with and without in-stent restenosis. Primary and secondary patency was significantly lower in patients with S/V ratio >1.30 (85 vs. 44%, p = 0.002 and 90 vs. 65%, p = 0.009, respectively). In conclusion, an S/V ratio was an independent predictor of in-stent restenosis after FP stenting, and it was also associated with the clinical outcome.
Background Factors associated with patency of self-expandable stents placed in the superficial femoral artery (SFA) have not been clarified. In this study, we investigated the impact of stent diameter in patients who implanted self-expandable stents in the SFA. Methods Self-expandable stents were placed in SFA lesions in 80 patients (84 limbs) at our hospital between January 2003 and December 2005 and we investigated prospectively for 18 months. A total of 144 stents were used: The mean vascular diameter at sites proximal and distal to the stent-placement region on angiography was defined as the vessel diameter, and the stent diameter/vessel diameter (S/V) ratio was calculated. Results The age of the patients ranged from 44 to 88 years old (mean: 70.3 ± 6.8 years old), and 68 patients were male (85%). The mean diameter of the treated vessels was 5.1 ± 0.7 mm, the mean lesion length was 93.8 ± 43.8 mm, and 1.7 ± 0.6 stents were used per lesion. Chronic total occlusion was noted in 24 cases (30%). The primary (secondary) patency rates at 6, 12, and 18 months were 91.2% (97.5%), 74.5% (87.2%), and 63.6% (79.1%), respectively as estimated by the Kaplan-Meier method. An S/V ratio >1.3 was noted in 16 of the 80 patients (20%). There was a high percentage of patients with renal dysfunction and a smoking habit in this group, and the length of the treated lesion was long. In contrast, there were fewer patients with a high cholesterol level in this group. Other baseline parameters were similar between the two groups. A Kaplan-Meier estimate showed that the restenosis rate after 18 months was significantly higher in the S/V >1.3 group (87.5% vs. 35.5%, p<0.0001), whereas the primary patency was lower (31.3% vs. 73.4%, p<0.0001). Multivariate analysis indicated that lesion length >100 mm (Hazard ratio (HR) 6.6, p=0.015), chronic total occlusion (HR 6.0, p=0.035), stent fracture(HR 17.5, p=0.022), and S/V >1.3(HR 29.0, p=0.0014) were independent predictors of primary patency at 18 months. conclusion The stent diameter of self-expandable stent was strongest predictor in primary patency at 18 months. The stent diameter of self-expandable stent can affect patency in the chronic phase.
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