Liao Chuan-Jun, Song Sheng-Han, Li Tan, Zhang Yang, Zhang Wang-de
Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Department of Vascular Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Ann Vasc Surg. 2019 Oct;60:301-307. doi: 10.1016/j.avsg.2019.02.018. Epub 2019 May 8.
The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR.
From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio <2.4 documented by duplex ultrasound at 12 months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ).
Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45 ± 0.14 at baseline and 0.84 ± 0.12 at 12 months (P < 0.05). The WIQ score was 30.45 ± 21.14 at baseline and 52.68 ± 29.75 at 12 months (P < 0.05). The Kaplan-Meier estimate of the primary patency rate at 12 months was 86.2% (25/29), and freedom from CD-TLR rate at 12 months was 89.7% (26/29).
The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.
股腘（FP）动脉支架内再狭窄（ISR）的最佳治疗方法仍存在争议。我们评估了Rotarex血栓切除术联合药物涂层球囊（DCB）治疗FP ISR的有效性和安全性。
2016年6月至2017年7月，32例行Rotarex血栓切除术联合DCB血管成形术的FP ISR患者被纳入一项前瞻性登记研究。主要终点是目标病变的初始通畅率，定义为12个月时经双功超声记录的收缩期峰值速度比<2.4，且无临床驱动的目标病变血运重建（CD-TLR）。次要结局指标是主要肢体不良事件发生率。主要功能终点采用步行障碍问卷（WIQ）进行评估。
29例（90.6%）患者完成了12个月的随访。基线时平均踝肱指数为0.45±0.14，12个月时为0.84±0.12（P<0.05）。WIQ评分基线时为30.45±21.14，12个月时为52.68±29.75（P<0.05）。12个月时初始通畅率的Kaplan-Meier估计值为86.2%（25/29），12个月时无CD-TLR率为89.7%（26/29）。
数据表明，Rotarex血栓切除术联合DCB治疗FP ISR是安全有效的，在12个月随访时初始通畅率和无CD-TLR率令人满意。
