Zhang Bihui, Niu Guochen, Yan Ziguang, Zou Yinghua, Tong Xiaoqiang, Yang Min
Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China.
Front Surg. 2021 Jan 13;7:616414. doi: 10.3389/fsurg.2020.616414. eCollection 2020.
To date, there have been few studies examining the efficacy and safety of drug-coated balloon (DCB) angioplasty in the treatment of Tosaka class III in-stent restenosis (ISR) lesions in the clinical setting. Therefore, this study aimed to investigate the clinical efficacy and safety of DCBs in patients with Tosaka class III ISR femoropopliteal lesions. This single-center study enrolled 28 femoropopliteal ISR Tosaka III patients who were treated by DCB angioplasty from September 2016 to September 2018. The patency, the freedom from target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints were analyzed during a 14-month follow-up period. Out of the 28 patients, 32.1% presented with critical limb ischemia. The mean lesion length was 250.4 ± 93.9 mm. Technical success was achieved in all lesions (100%). Debulking devices were used in 50% of lesions, and bailout stents were performed in 3.6% of patients. Kaplan Meier estimates that the 14-month primary patency was 79.2% (95% CI 60.6-97.8%), whereas the freedom from TLR rate was 91.5% (95% CI 80.1-100%). Clinical symptoms improved by at least 1 Rutherford category in 82.1% of limbs. The ankle-brachial index (ABI) values improved from 0.51 ± 0.30 to 1.05 ± 0.22 at the final follow-up ( < 0.001). The rate of freedom from 30-day major adverse limb events (MALEs) was 100%. The mortality rate was 7.1%. These results suggested that the use of DCBs is safe and effective in treating femoropopliteal Tosaka class III ISR lesions.
迄今为止，在临床环境中，很少有研究考察药物涂层球囊（DCB）血管成形术治疗托萨卡III级支架内再狭窄（ISR）病变的疗效和安全性。因此，本研究旨在探讨DCB治疗托萨卡III级ISR股腘病变患者的临床疗效和安全性。这项单中心研究纳入了2016年9月至2018年9月期间接受DCB血管成形术治疗的28例股腘ISR托萨卡III级患者。在14个月的随访期内分析通畅率、靶病变血运重建（TLR）率、临床改善情况和安全性终点。28例患者中，32.1%出现严重肢体缺血。平均病变长度为250.4±93.9毫米。所有病变均取得技术成功（100%）。50%的病变使用了减容装置，3.6%的患者进行了补救性支架置入。Kaplan Meier估计14个月的主要通畅率为79.2%（95%CI 60.6-97.8%），而无TLR率为91.5%（95%CI 80.1-100%）。82.1%的肢体临床症状至少改善1个卢瑟福分级。末次随访时踝肱指数（ABI）值从0.51±0.30提高到1.05±0.22（<0.001）。30天主要肢体不良事件（MALE）发生率为100%。死亡率为7.1%。这些结果表明，使用DCB治疗股腘托萨卡III级ISR病变是安全有效的。
