Vascular and Interventional Radiology Unit, Department of Radiological Sciences, Sapienza University of Rome, 324 Viale Regina Elena, 00161, Rome, Italy,
Cardiovasc Intervent Radiol. 2013 Oct;36(5):1232-40. doi: 10.1007/s00270-012-0543-5. Epub 2013 Jan 9.
To describe the 1-year results of drug-eluting nitinol stent placement in the femoropopliteal artery of diabetic and nondiabetic patients.
All patients enrolled in this prospective, multicenter study underwent paclitaxel-eluting stent placement for de novo or restenotic lesions of the superficial femoral and/or popliteal artery. Baseline and follow-up walking impairment questionnaire (WIQ) scores, Rutherford classifications, and ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 1, 6, and 12 months.
There were 285 diabetic patients and 502 nondiabetic patients treated. There were no significant differences in mean lesion length or lesion calcification between patient groups. Procedural success in both treatment groups was >97 %. There were no significant differences between diabetic and nondiabetic groups in Kaplan-Meier estimates of patency, event-free survival (EFS), or freedom from target lesion revascularization (TLR) at 6 and 12 months. Both groups experienced a significant increase in ABI and WIQ values after treatment, and these improvements were sustained to 12-month follow-up; however, nondiabetic patients had significantly greater 6- and 12-month WIQ scores compared with diabetic patients. Based on covariate analysis, the only factors shown to be significant and to negatively influence patency were longer lesion length (p = 0.009), higher Rutherford classification (p = 0.02), and lack of hypertension (p = 0.02); diabetic status was not found to be a significant factor.
Diabetic and nondiabetic patients had similar estimates of primary patency, EFS, and freedom from TLR; however, diabetic patients showed less improvement in WIQ scores compared with nondiabetic patients.
描述药物洗脱镍钛诺支架在糖尿病和非糖尿病患者股腘动脉中的 1 年结果。
所有纳入本前瞻性、多中心研究的患者均因股浅动脉和/或腘动脉的初发或再狭窄病变而行紫杉醇洗脱支架置入术。在基线和随访时均进行步行障碍问卷（WIQ）评分、Rutherford 分级和踝肱指数（ABI）测量。随访在 1、6 和 12 个月完成。
共治疗 285 例糖尿病患者和 502 例非糖尿病患者。两组患者的平均病变长度或病变钙化程度均无显著差异。两组患者的手术成功率均>97%。两组患者的通畅率、无事件生存率（EFS）或免于靶病变血运重建（TLR）的Kaplan-Meier 估计值在 6 个月和 12 个月时均无显著差异。两组患者的 ABI 和 WIQ 值在治疗后均显著升高，且这种改善持续到 12 个月随访；然而，与糖尿病患者相比，非糖尿病患者在 6 个月和 12 个月时的 WIQ 评分显著更高。基于协变量分析，唯一显示与通畅率显著负相关的因素是病变长度较长（p=0.009）、Rutherford 分级较高（p=0.02）和无高血压（p=0.02）；而糖尿病状态并非显著因素。
糖尿病和非糖尿病患者的主要通畅率、EFS 和免于 TLR 的估计值相似；然而，与非糖尿病患者相比，糖尿病患者的 WIQ 评分改善程度较低。
