Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Hyogo, Japan.
J Endovasc Ther. 2011 Dec;18(6):753-61. doi: 10.1583/11-3581.1.
To investigate the long-term outcomes of nitinol stenting in femoropopliteal lesions and to determine the factors associated with restenosis.
Between December 2003 and December 2009, 861 patients (603 men; mean age 72 years) underwent nitinol stenting of the femoropopliteal segment in 1017 limbs. A quarter (26%) of the patients had critical limb ischemia. Mean lesion length was 152±93 mm. Stent patency was assessed by either duplex ultrasound or angiography and analyzed by Kaplan-Meier estimation. The determinants of restenosis were explored with Cox proportional hazard regression analyses; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Risk stratification of primary patency was subsequently analyzed using a score based on the significant prognostic factors identified in the multivariate model.
Stent fracture occurred in 10% (104 limbs) of the lesions. At 1, 3, and 6 years, the primary patency rates were 77%, 67%, and 63%; secondary patency rates were 91%, 87%, and 87%; freedom from femoropopliteal bypass grafting was 99%, 97%, and 96%, respectively. Multivariate Cox regression analysis identified female gender (HR 1.899; 95% CI 1.318 to 2.737, p<0.001), ankle-brachial index <0.6 (HR 1.921; 95% CI 1.348 to 2.736, p<0.001), TASC II C/D lesion (HR 2.068; 95% CI 1.346 to 3.177, p = 0.0009), stent fracture (HR 1.937; 95% CI 1.203 to 3.118, p = 0.006), and the absence of cilostazol administration (HR 2.102; 95% CI 1.394 to 3.172, p<0.001) as strong independent factors associated with restenosis. After assigning a risk score based on the outcomes of the multivariate regression analysis (1 each for female gender, ABI <0.6, TASC II C/D, stent fracture, and absence of cilostazol therapy), primary patency was found to be lower in limb groups with a higher cumulative score (12-month primary patency: score 0: 93%, score 1: 80%, score 2: 73%, score 3; 47%, score 4: 0%, respectively; p<0.001).
Endovascular therapy using nitinol stents for FP lesions yielded acceptable outcomes up to 6 years. Risk stratification for patency can play an important role in estimating future occurrence of restenosis after nitinol stent implantation in FP lesions.
探讨镍钛诺支架治疗股腘病变的长期疗效，并确定与再狭窄相关的因素。
2003 年 12 月至 2009 年 12 月，861 例（603 例男性；平均年龄 72 岁）患者的 1017 条肢体接受了股腘段镍钛诺支架置入术。四分之一（26%）的患者患有严重肢体缺血。平均病变长度为 152±93mm。通过双功能超声或血管造影评估支架通畅性，并通过 Kaplan-Meier 估计进行分析。使用 Cox 比例风险回归分析探讨再狭窄的决定因素；结果以风险比（HR）和 95%置信区间（CI）表示。随后使用基于多变量模型中确定的显著预后因素的评分对主要通畅率进行风险分层分析。
10%（104 条肢体）的病变发生支架断裂。1、3 和 6 年时，主要通畅率分别为 77%、67%和 63%；次要通畅率分别为 91%、87%和 87%；免于股腘旁路移植术的比例分别为 99%、97%和 96%。多变量 Cox 回归分析确定女性（HR 1.899；95%CI 1.318 至 2.737，p<0.001）、踝肱指数<0.6（HR 1.921；95%CI 1.348 至 2.736，p<0.001）、TASC II C/D 病变（HR 2.068；95%CI 1.346 至 3.177，p=0.0009）、支架断裂（HR 1.937；95%CI 1.203 至 3.118，p=0.006）和未使用西洛他唑（HR 2.102；95%CI 1.394 至 3.172，p<0.001）是与再狭窄强烈相关的独立因素。根据多变量回归分析的结果（女性、ABI<0.6、TASC II C/D、支架断裂和缺乏西洛他唑治疗各 1 分）分配风险评分后，发现累积评分较高的肢体组主要通畅率较低（12 个月时主要通畅率：评分 0：93%，评分 1：80%，评分 2：73%，评分 3：47%，评分 4：0%，p<0.001）。
用于 FP 病变的镍钛诺支架血管内治疗在 6 年内获得了可接受的结果。通畅率的风险分层对于估计 FP 病变中镍钛诺支架植入后再狭窄的未来发生具有重要作用。
