Department of Diagnostic and Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece.
J Endovasc Ther. 2012 Dec;19(6):788-96. doi: 10.1583/JEVT-12-3993R.1.
To investigate the outcomes following primary deployment of drug-eluting stents (DES) for the treatment of infrapopliteal bifurcation lesions in patients suffering from critical limb ischemia (CLI).
This was a retrospective study of a registry enrolling all patients suffering from chronic infrapopliteal artery disease and undergoing treatment of tibial bifurcation lesions with DES using 3 techniques: balloon and stent (single stent), T-shape double-stent, and culotte double-stent. The analysis included 39 CLI patients (32 men; mean age 69 ± 10 years) who underwent primary stenting of 41 infrapopliteal bifurcations. Most patients (29, 70.7%) were classified as Rutherford category 4. The mean lesion length was 31.3 ± 13.1 mm. The primary endpoints were amputation-free survival, target lesion revascularization (TLR)-free survival, angiographic 2-vessel primary patency (2VPP), and 1-vessel primary patency (1VPP). Secondary endpoints included survival and angiographic binary restenosis. A Cox regression analysis was performed to identify independent predictors influencing outcomes
Technical success was achieved in all cases. The mean clinical and angiographic follow-up intervals were 47.5 ± 14.8 and 17.5 ± 12.5 months, respectively. According to the Kaplan-Meier analysis, overall survival, amputation-free survival, and TLR-free survival estimates were 79.5%, 84.3%, and 58.0%, respectively, at 5 years. At 12, 24, and 36 months, the 2VPP rates were 77.2%, 47.5%, and 33.9%, and the 1VPP rates were 84.0%, 65.5%, and 54.5%, respectively. Binary restenosis rates were 26.4%, 57.3%, and 82.2% at 12, 24, and 36 months; restenotic lesions were mainly detected at the origin of the bifurcations. The regression model did not identify any independent predictors influencing outcome.
DES application for below-the-knee bifurcation lesions was safe and resulted in satisfactory long-term angiographic and clinical outcomes comparable to those reported following infrapopliteal endovascular treatment.
研究药物洗脱支架（DES）治疗伴有严重肢体缺血（CLI）的患者的膝下分叉病变的主要治疗结果。
这是一项回顾性研究，对所有患有慢性膝下动脉疾病并接受DES 治疗的胫骨分叉病变患者进行登记，使用 3 种技术：球囊和支架（单支架）、T 型双支架和 Culotte 双支架。分析包括 39 名 CLI 患者（32 名男性；平均年龄 69 ± 10 岁），对 41 个膝下分叉病变进行了初次支架置入。大多数患者（29 名，70.7%）被分类为 Rutherford 4 级。平均病变长度为 31.3 ± 13.1mm。主要终点为免于截肢的生存、免于靶病变血运重建（TLR）的生存、血管造影 2 支血管通畅率（2VPP）和 1 支血管通畅率（1VPP）。次要终点包括生存和血管造影二元再狭窄。进行 Cox 回归分析以确定影响结果的独立预测因素。
所有病例均获得技术成功。平均临床和血管造影随访时间分别为 47.5 ± 14.8 和 17.5 ± 12.5 个月。根据 Kaplan-Meier 分析，5 年时总体生存率、免于截肢的生存率和 TLR 无事件生存率估计分别为 79.5%、84.3%和 58.0%。在 12、24 和 36 个月时，2VPP 率分别为 77.2%、47.5%和 33.9%，1VPP 率分别为 84.0%、65.5%和 54.5%。12、24 和 36 个月时二元再狭窄率分别为 26.4%、57.3%和 82.2%；再狭窄病变主要发生在分叉处的起源处。回归模型未确定任何影响结果的独立预测因素。
DES 应用于膝下分叉病变是安全的，并且可获得令人满意的长期血管造影和临床结果，与膝下血管内治疗后报道的结果相当。
