Chen Caibo, Guan Haitao, Shen Siyuan, Li Pengyu, She Kang, Cheng Gong, Niu Guochen, Yan Ziguang, Yao Ziping, Zou Yinghua, Yang Min, Zhang Bihui
Department of Interventional Radiology and Vascular Surgery, Peking University First Hospital, Beijing, China.
Quant Imaging Med Surg. 2025 Sep 1;15(9):7727-7737. doi: 10.21037/qims-2025-367. Epub 2025 Aug 14.
Drug-delivering devices have shown efficacy in clinical trials and are widely used for femoropopliteal artery disease. However, the optimal strategy for complex lesions, such as TransAtlantic Inter-Society Consensus (TASC) C and D lesions, remains debated in real-world practice. This propensity score-matched study aimed to compare the mid-term outcomes between a double-drug strategy [drug-coated balloon (DCB) combined with systemic drug-eluting stents (DES)] and a DCB bailout strategy (DCB with bailout bare-metal stents) in patients with TASC C and D femoropopliteal lesions.
This retrospective single-center study included TASC C and D femoropopliteal patients treated with DCB from October 2016 to July 2024. Propensity score matching (PSM) was performed in a 1:3 ratio, with one patient in the double-drug strategy group for every three in the DCB bailout group. The primary endpoint was 24-month primary patency. Secondary endpoints included freedom from clinically-driven target lesion revascularization (CD-TLR), mortality, complications, symptom improvement, and risk factors for restenosis.
After PSM, 32 pairs of patients were analyzed. Baseline characteristics were well-balanced [standardized mean difference (SMD) <0.2 for all covariates]. Primary patency rates at 24 months were comparable (double-drug DCB bailout: 64.5% 76.4%, P=0.76). Freedom from CD-TLR showed no significant difference at 24 months (double-drug DCB bailout: 95.8% 79.1%, P=0.20). The double drug group demonstrated superior Rutherford category improvement (P=0.042). Mortality and complication rates were similar between groups. Dyslipidemia was identified as an independent predictor of loss of primary patency [hazard ratio (HR) =3.03, P=0.024].
The double-drug strategy and DCB bailout strategy yielded comparable 24-month patency and freedom from target lesion revascularization (TLR) in TASC C and D lesions.
药物输送装置在临床试验中已显示出疗效，并广泛应用于股腘动脉疾病。然而，在实际临床实践中，对于复杂病变，如跨大西洋协作组（TASC）C 型和 D 型病变，最佳治疗策略仍存在争议。本倾向评分匹配研究旨在比较双药策略[药物涂层球囊（DCB）联合全身药物洗脱支架（DES）]与 DCB 补救策略（DCB 联合补救性裸金属支架）在 TASC C 型和 D 型股腘病变患者中的中期疗效。
这项回顾性单中心研究纳入了 2016 年 10 月至 2024 年 7 月期间接受 DCB 治疗的 TASC C 型和 D 型股腘病变患者。倾向评分匹配（PSM）以 1:3 的比例进行，即 DCB 补救组每 3 例患者对应双药策略组 1 例患者。主要终点为 24 个月时的主要通畅率。次要终点包括免于临床驱动的靶病变血运重建（CD-TLR）、死亡率、并发症、症状改善情况以及再狭窄的危险因素。
PSM 后，分析了 32 对患者。基线特征达到良好平衡[所有协变量的标准化均数差（SMD）<0.2]。24 个月时的主要通畅率相当（双药策略组 vs DCB 补救组：64.5% vs 76.4%，P = 0.76）。24 个月时免于 CD-TLR 无显著差异（双药策略组 vs DCB 补救组：95.8% vs 79.1%，P = 0.20）。双药组在卢瑟福分级改善方面表现更优（P = 0.042）。两组间死亡率和并发症发生率相似。血脂异常被确定为主要通畅率丧失的独立预测因素[风险比（HR）= 3.03，P = 0.024]。
在 TASC C 型和 D 型病变中，双药策略和 DCB 补救策略在 24 个月时的通畅率以及免于靶病变血运重建（TLR）方面相当。
