Abstract：
BACKGROUND: To evaluate the midterm clinical efficacy of paclitaxel drug-coated balloons (DCBs) in the treatment of femoral artery TransAtlantic Inter-Society Consensus (TASC) grades C/D lesions.
METHODS: The clinical data of 73 cases with TASC grades C/D lesions of femoral artery treated with paclitaxel DCBs at the Department of Vascular Surgery, the First Hospital of Fujian Medical University from August 2016 to January 2020 were retrospectively analyzed. The primary endpoint was the primary patency rate. The secondary endpoints were freedom from reintervention, Rutherford classification, ankle-brachial index (ABI), amputation events, and all-cause death.
RESULTS: A total of 73 cases of limb lesions received endoluminal treatment. The mean age of the patients including 49 males and 24 females was (72.66 ± 11.1) years, with an initial Rutherford classification of 2-5 and an ABI of 0.4 ± 0.1. The mean Rutherford classification was 3.70 ± 0.95. The mean lesion length was (25.75 ± 9.67) cm, including 61.64% chronic occlusive lesions and 27.39% stenotic lesions, the remaining 10.97% were mixed lesions, containing multiple segments of stenosis and chronic total occlusion lesions. 43.8% of the lesions were associated with severe calcification. Stent implantation rate was 8%. Overall mortality at follow-up was 4% at 1 year and 8% at 2 years, and no amputations seen. The ABI was 0.83 ± 0.07 at 1-year follow-up and 0.78 ± 0.05 at 2-year follow-up. The Kaplan-Meier survival curve predicted the 1-year phase I patency rate was 75.3% ± 5% and the 2-year patency rate was 63.3% ± 5.7%. Freedom from target lesion revascularization was 78.4 ± 4.9% at 1 year and 69.2% ± 3.6% at 2 years. Logistic regression analysis showed that diabetes mellitus, severe calcification, chronic renal insufficiency, and restenosis were the significant factors affecting the patency of target lesions.
CONCLUSIONS: Paclitaxel DCBs in the treatment of femoral artery with TASC grades C/D lesions can achieve relatively satisfactory midterm clinical safety and efficacy results, provided there is an acceptable result on completion angiogram.
METHODS: The clinical data of 73 cases with TASC grades C/D lesions of femoral artery treated with paclitaxel DCBs at the Department of Vascular Surgery, the First Hospital of Fujian Medical University from August 2016 to January 2020 were retrospectively analyzed. The primary endpoint was the primary patency rate. The secondary endpoints were freedom from reintervention, Rutherford classification, ankle-brachial index (ABI), amputation events, and all-cause death.
RESULTS: A total of 73 cases of limb lesions received endoluminal treatment. The mean age of the patients including 49 males and 24 females was (72.66 ± 11.1) years, with an initial Rutherford classification of 2-5 and an ABI of 0.4 ± 0.1. The mean Rutherford classification was 3.70 ± 0.95. The mean lesion length was (25.75 ± 9.67) cm, including 61.64% chronic occlusive lesions and 27.39% stenotic lesions, the remaining 10.97% were mixed lesions, containing multiple segments of stenosis and chronic total occlusion lesions. 43.8% of the lesions were associated with severe calcification. Stent implantation rate was 8%. Overall mortality at follow-up was 4% at 1 year and 8% at 2 years, and no amputations seen. The ABI was 0.83 ± 0.07 at 1-year follow-up and 0.78 ± 0.05 at 2-year follow-up. The Kaplan-Meier survival curve predicted the 1-year phase I patency rate was 75.3% ± 5% and the 2-year patency rate was 63.3% ± 5.7%. Freedom from target lesion revascularization was 78.4 ± 4.9% at 1 year and 69.2% ± 3.6% at 2 years. Logistic regression analysis showed that diabetes mellitus, severe calcification, chronic renal insufficiency, and restenosis were the significant factors affecting the patency of target lesions.
CONCLUSIONS: Paclitaxel DCBs in the treatment of femoral artery with TASC grades C/D lesions can achieve relatively satisfactory midterm clinical safety and efficacy results, provided there is an acceptable result on completion angiogram.
摘要：
背景：评估紫杉醇药物涂层球囊（DCB）治疗股动脉跨大西洋学会间共识（TASC）C/D级病变的中期临床疗效。
方法：血管外科73例股动脉TASCC/D级病变患者的临床资料，回顾性分析福建医科大学附属第一医院2016年8月至2020年1月.主要终点是主要通畅率。次要终点是免于再干预，卢瑟福分类,踝肱指数(ABI),截肢事件,和全因死亡。
结果：共有73例肢体病变接受腔内治疗。男性49例,女性24例,平均年龄(72.66±11.1)岁,最初的卢瑟福分类为2-5，ABI为0.4±0.1。平均卢瑟福分类为3.70±0.95。平均病灶长度(25.75±9.67)cm,包括61.64%的慢性闭塞性病变和27.39%的狭窄病变,其余10.97%为混合性病变,包含多个狭窄段和慢性完全闭塞病变。43.8％的病变与严重钙化有关。支架植入率为8%。随访1年时的总死亡率为4%，2年时为8%。也没有看到截肢。1年随访时ABI为0.83±0.07，2年随访时ABI为0.78±0.05。Kaplan-Meier存活曲线预测1年I期通畅率为75.3%±5%，2年通畅率为63.3%±5.7%。无靶病变血运重建1年为78.4±4.9%，2年为69.2%±3.6%。Logistic回归分析显示,糖尿病,严重钙化,慢性肾功能不全，再狭窄是影响靶病变通畅的重要因素。
结论：紫杉醇DCBs治疗TASCC/D级股动脉病变可取得较满意的中期临床安全性和疗效。前提是完成血管造影的结果可以接受。
方法：血管外科73例股动脉TASCC/D级病变患者的临床资料，回顾性分析福建医科大学附属第一医院2016年8月至2020年1月.主要终点是主要通畅率。次要终点是免于再干预，卢瑟福分类,踝肱指数(ABI),截肢事件,和全因死亡。
结果：共有73例肢体病变接受腔内治疗。男性49例,女性24例,平均年龄(72.66±11.1)岁,最初的卢瑟福分类为2-5，ABI为0.4±0.1。平均卢瑟福分类为3.70±0.95。平均病灶长度(25.75±9.67)cm,包括61.64%的慢性闭塞性病变和27.39%的狭窄病变,其余10.97%为混合性病变,包含多个狭窄段和慢性完全闭塞病变。43.8％的病变与严重钙化有关。支架植入率为8%。随访1年时的总死亡率为4%，2年时为8%。也没有看到截肢。1年随访时ABI为0.83±0.07，2年随访时ABI为0.78±0.05。Kaplan-Meier存活曲线预测1年I期通畅率为75.3%±5%，2年通畅率为63.3%±5.7%。无靶病变血运重建1年为78.4±4.9%，2年为69.2%±3.6%。Logistic回归分析显示,糖尿病,严重钙化,慢性肾功能不全，再狭窄是影响靶病变通畅的重要因素。
结论：紫杉醇DCBs治疗TASCC/D级股动脉病变可取得较满意的中期临床安全性和疗效。前提是完成血管造影的结果可以接受。
