Department of Vascular and Endovascular Surgery, Assiut University Hospital, Assiut, Egypt.
Qena Vascular Surgery Department, South Valley University, Qena, Egypt.
Vascular. 2024 Aug;32(4):834-841. doi: 10.1177/17085381231162123. Epub 2023 Mar 10.
Paclitaxel drug-coated balloon (PDCB) angioplasty has been shown to be an effective treatment of in-stent restenosis (ISR) at the femoropopliteal (FP) arteries. Long-term studies, however, have shown a progressive decrease in the patency rates following PDCB. The aim of this study was to determine the predictors of stenosis recurrence after PDCB treatment of FP-ISR, and its immediate and mid-term outcomes.
This prospective, non-randomized study included all chronic lower extremity ischemia patients of Rutherford class 3-6 who underwent PDCB angioplasty to treat >50% FP-ISR between June 2017 and December 2019. The primary endpoint was primary patency, defined as freedom from binary restenosis and freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months. Secondary endpoints included 12-months freedom from CD-TLR and major adverse events (MAEs).
A total of 73 symptomatic chronic limb ischemia patients (73 limbs including 63 with limb threatening ischemia) underwent PDCB angioplasty of FP-ISR lesions (13.7% Tosaka class I, 54.8% class II, and 31.5% class III). The mean ISR lesion length was 121.8 ± 52.7 mm. Technical success was achieved in 70 (95.9%) patients. Kaplan-Meier estimate of the 12-months rates of primary patency and freedom from CD-TLR was 76.1% and 87.4%, respectively. At one year, MAEs occurred in eight patients (11.0%) including two deaths (2.7%), one major amputation (1.4%), and six (8.2%) surgical revascularizations. Multivariable analysis showed that Tosaka class III ISR (HR 4.51, CI: 1.31-15.53, < 0.001) and reference vessel diameter (HR 0.38, 95% CI: 0.18-080, = 0.01) were independently associated with recurrent ISR.
PDCB is safe and effective treatment of FP-ISR lesions. Occlusive ISR lesions and reference vessel diameter were independently associated with recurrent ISR stenosis after PDCB treatment.
紫杉醇药物涂层球囊（PDCB）血管成形术已被证明是治疗股腘（FP）动脉内支架再狭窄（ISR）的有效方法。然而，长期研究表明，PDCB 治疗后通畅率逐渐下降。本研究旨在确定 PDCB 治疗 FP-ISR 后再狭窄的预测因素及其即刻和中期结果。
这项前瞻性、非随机研究纳入了 2017 年 6 月至 2019 年 12 月期间因 >50% FP-ISR 接受 PDCB 血管成形术治疗的所有 Rutherford 分级 3-6 级慢性下肢缺血患者。主要终点是 12 个月时无二元再狭窄和无临床驱动的靶病变血运重建（CD-TLR）的通畅率。次要终点包括 12 个月时无 CD-TLR 和主要不良事件（MAE）。
共有 73 例有症状的慢性肢体缺血患者（73 条肢体，其中 63 条肢体伴有肢体威胁性缺血）接受了 PDCB 血管成形术治疗 FP-ISR 病变（13.7% Tosaka Ⅰ级，54.8%Ⅱ级，31.5%Ⅲ级）。ISR 病变长度平均为 121.8±52.7mm。70 例（95.9%）患者获得技术成功。Kaplan-Meier 估计的 12 个月通畅率和无 CD-TLR 率分别为 76.1%和 87.4%。一年时，8 例患者（11.0%）发生 MAE，包括 2 例死亡（2.7%）、1 例大截肢（1.4%）和 6 例（8.2%）手术血运重建。多变量分析显示，Tosaka Ⅲ级 ISR（HR 4.51，95%CI：1.31-15.53， < 0.001）和参考血管直径（HR 0.38，95%CI：0.18-0.80， = 0.01）与复发性 ISR 独立相关。
PDCB 是治疗 FP-ISR 病变的安全有效方法。闭塞性 ISR 病变和参考血管直径与 PDCB 治疗后复发性 ISR 狭窄独立相关。
