Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
J Endovasc Ther. 2011 Feb;18(1):1-12. doi: 10.1583/10-3242.1.
To report the long-term outcomes of a single-center prospective study investigating primary placement of everolimus-eluting metal stents for recanalization of long infrapopliteal lesions compared to a matched historical control group treated with plain balloon angioplasty and provisional placement of bare metal stents in a bailout manner.
The study included 81 patients (63 men; mean age 71 years, range 45-85) suffering from critical limb ischemia (CLI) and angiographically proven long-segment (at least 1 lesion >4.5 cm) de novo infrapopliteal artery disease who underwent below-the-knee revascularization with either primary placement of everolimus-eluting stents (n = 47, 51 limbs, 102 lesions) or angioplasty and bailout bare metal stenting (n = 34, 36 limbs, 72 lesions). Clinical and angiographic follow-up was collected at regular time intervals. Primary clinical and angiographic endpoints included patient survival, major amputation-free survival, angiographic primary patency, angiographic binary restenosis (>50%), and overall event-free survival. Results were stratified according to endovascular treatment received. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity.
Baseline demographics were well matched. No significant differences were identified between the 2 groups with regard to overall 3-year patient survival (82.2% versus 65.7%; p = 0.90) and amputation-free survival (77.1% versus 86.9%; p = 0.20). Up to 3 years, lesions fully covered with everolimus-eluting stents were associated with significantly higher primary patency [hazard ratio (HR) 7.98, 95% CI 3.69 to 17.25, p < 0.0001], reduced binary restenosis (HR 2.94, 95% CI 1.74 to 4.99, p < 0.0001), and improved overall event-free survival (HR 2.19, 95% CI 1.16 to 4.13, p = 0.015) versus the matched historical control group.
Primary infrapopliteal everolimus-eluting stenting for CLI treatment significantly inhibits restenosis and improves long-term angiographic patency and overall patient event-free survival compared to balloon angioplasty and bailout bare metal stenting.
报告一项单中心前瞻性研究的长期结果，该研究调查了初次放置依维莫司洗脱金属支架治疗长段（至少 1 个病变＞4.5cm）下肢动脉再通与匹配的历史对照组中单纯球囊血管成形术和临时放置裸金属支架治疗的效果。
该研究纳入了 81 名（63 名男性；平均年龄 71 岁，范围 45-85 岁）患有严重肢体缺血（CLI）和经血管造影证实的长段（至少 1 个病变＞4.5cm）新发生的下肢动脉疾病的患者，他们接受了膝下血运重建，初次放置依维莫司洗脱支架（n=47，51 条肢体，102 个病变）或单纯球囊血管成形术和临时放置裸金属支架（n=34，36 条肢体，72 个病变）。以定期时间间隔收集临床和血管造影随访。主要临床和血管造影终点包括患者生存率、免于主要截肢的生存率、血管造影初始通畅率、血管造影二进制再狭窄（＞50%）和总体无事件生存率。结果根据接受的血管内治疗进行分层。应用多变量 Cox 比例风险回归分析调整混杂因素的异质性。
基线人口统计学特征匹配良好。2 组之间在 3 年总体患者生存率（82.2%与 65.7%；p=0.90）和免于截肢的生存率（77.1%与 86.9%；p=0.20）方面无显著差异。在 3 年期间，完全覆盖依维莫司洗脱支架的病变与显著更高的初始通畅率相关[风险比（HR）7.98，95%置信区间（CI）3.69 至 17.25，p＜0.0001]、降低的二进制再狭窄（HR 2.94，95% CI 1.74 至 4.99，p＜0.0001）和改善的总体无事件生存率（HR 2.19，95% CI 1.16 至 4.13，p=0.015）与匹配的历史对照组相比。
与单纯球囊血管成形术和临时放置裸金属支架相比，初次下肢动脉依维莫司洗脱支架治疗严重肢体缺血可显著抑制再狭窄，并改善长期血管造影通畅率和总体患者无事件生存率。
