Abstract：
BACKGROUND: Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions.Methods and Results: This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4.
CONCLUSIONS: No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.
CONCLUSIONS: No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.
摘要：
背景：已经建立了使用诸如药物涂层球囊（DCB）和药物洗脱支架（DES）之类的设备治疗股pop动脉粥样硬化性疾病的血管内治疗（EVT）。然而,EVT使用基于药物的设备治疗慢性威胁肢体缺血（CLTI）仍然具有挑战性。CLTI患者FP病变的最佳装置仍不清楚。本研讨比拟了DCB和DES对CLTI和FP病变患者的临床疗效。方法和结果：这项回顾性单中心研究包括2018年1月至2022年12月期间接受EVT治疗的539例连续患者（562个病灶）；166例CLTI和卢瑟福5级或6级伤口患者接受DCB或DES的EVT治疗。在倾向评分匹配后，对53对患者的临床结果进行比较。DCB组和DES组在伤口完全愈合而无死亡或严重截肢的发生率方面没有显着差异（84.8％vs.80.2%,分别为；P=0.99)，原发性通畅性（69.4%vs.75.6%,分别为；P=0.65)，1年无靶病变血运重建(78.6%vs.78.0%,分别为；P=0.92）。多因素分析显示,1年伤口完全愈合与血液透析和伤口,缺血，和足部感染阶段4，但与全球肢体解剖分期系统FP等级3或4呈正相关。
结论：对于有CLTI和FP病变的患者，DCB和DES之间的临床结果没有发现显著差异。
结论：对于有CLTI和FP病变的患者，DCB和DES之间的临床结果没有发现显著差异。
