Kawamura Yoshihiro, Ishii Hideki, Aoyama Toru, Tanaka Miho, Takahashi Hiroshi, Kumada Yoshitaka, Toriyama Takanobu, Murohara Toyoaki
Cardiovascular Center, Nagoya Kyoritsu Hospital, Nagoya, Japan.
J Vasc Surg. 2009 Nov;50(5):1057-62. doi: 10.1016/j.jvs.2009.07.017. Epub 2009 Sep 26.
Although percutaneous transluminal angioplasty (PTA) has become a common therapeutic standard for peripheral artery disease (PAD), high restenosis rates in the superficial femoral artery (SFA) remain a major problem. Nitinol stent implantation is reported to reduce restenosis in SFA after PTA in the general population; however, little is known about whether the nitinol stent improves primary patency after PTA in hemodialysis patients who are at higher risk of revascularization failure. The aim of this study was to clarify the effects of nitinol stent implantation for primary patency in SFA after PTA in hemodialysis patients with PAD.
Eighty consecutive hemodialysis patients (167 SFA lesions) who underwent PTA with nitinol stents from January 2006 to January 2008 were compared with 64 hemodialysis patients (128 SFA lesions) who received stainless steel stents in the preceding 2 years. In the follow-up study to 2 years, incidence of restenosis, amputation, and all-cause mortality were analyzed. End points between the groups were examined with the Kaplan-Meier and log-rank methods. Prognostic values for end points were calculated by a Cox univariate analysis and Cox multivariable regression models. To statistically minimize the differences in each stent group, a propensity-matched analysis was also performed using the model including male gender, age, diabetes, hypertension, hyperlipidemia, smoking, incidence of ulcer/gangrene, and TransAtlantic Inter-Society Consensus (TASC) type C+D.
The 2-year primary patency rate was 58% in the nitinol group vs 42% in the stainless steel group (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.39-0.84; P = .0045), despite a higher prevalence of TASC C+D lesion in the nitinol group (68% vs 49%, P = .0014). In 108 lesions matched after propensity score analysis, the primary patency for 2 years was 64% in the nitinol group vs 42% in the stainless steel group (HR, 0.39; 95% CI, 0.24-0.65; P = .0003). Cox multivariate models showed nitinol stent (HR, 0.42; 95% CI, 0.25-0.73; P = .002), age (HR, 1.04; 95% CI, 1.01-1.08; P = .031), and incidence of ulcer/gangrene (HR, 2.35; 95% CI, 1.17-4.75; P = .017) were independent predictors of restenosis.
These data suggest that nitinol stent implantation improves primary patency in SFA after PTA compared with the stainless steel stent, even in hemodialysis patients with PAD.
尽管经皮腔内血管成形术（PTA）已成为外周动脉疾病（PAD）的常见治疗标准，但股浅动脉（SFA）的高再狭窄率仍然是一个主要问题。据报道，镍钛诺支架植入可降低普通人群PTA术后SFA的再狭窄率；然而，对于镍钛诺支架能否改善血管再通失败风险较高的血液透析患者PTA术后的初始通畅率，人们知之甚少。本研究的目的是阐明镍钛诺支架植入对PAD血液透析患者PTA术后SFA初始通畅率的影响。
将2006年1月至2008年1月连续80例接受镍钛诺支架PTA的血液透析患者（167个SFA病变）与前两年接受不锈钢支架的64例血液透析患者（128个SFA病变）进行比较。在为期2年的随访研究中，分析再狭窄、截肢和全因死亡率的发生率。采用Kaplan-Meier法和对数秩检验法检查两组之间的终点。通过Cox单变量分析和Cox多变量回归模型计算终点的预后值。为了在统计学上尽量减少每个支架组之间的差异，还使用包括男性、年龄、糖尿病、高血压、高脂血症、吸烟、溃疡/坏疽发生率和跨大西洋两岸社会共识（TASC）C+D型在内的模型进行了倾向匹配分析。
镍钛诺组2年初始通畅率为58%，不锈钢组为42%（风险比[HR]，0.58；95%置信区间[CI]，0.39 - 0.84；P = 0.0045），尽管镍钛诺组TASC C+D病变的患病率更高（68%对49%，P = 0.0014）。在倾向得分分析后匹配的108个病变中，镍钛诺组2年初始通畅率为64%，不锈钢组为42%（HR，0.39；95% CI，0.24 - 0.65；P = 0.0003）。Cox多变量模型显示，镍钛诺支架（HR，0.42；95% CI，0.25 - 0.73；P = 0.002）、年龄（HR，1.04；95% CI，1.01 - 1.08；P = 0.031）和溃疡/坏疽发生率（HR，2.35；95% CI，1.17 - 4.75；P = 0.017）是再狭窄的独立预测因素。
这些数据表明，即使在PAD血液透析患者中，与不锈钢支架相比，镍钛诺支架植入也能提高PTA术后SFA的初始通畅率。
