BackgroundDespite the widespread use of drug‐coated balloons (DCBs) for femoropopliteal (FP) lesions, there is still no consensus on treatment strategies for DCB restenosis. This study aimed to determine the risk factors for recurrent restenosis after repeat DCB therapy for DCB restenosis in FP lesions.MethodsThis multicenter retrospective study assessed 1176 consecutive limbs in 860 patients who successfully received initial DCB therapy for FP lesions at four cardiovascular centers between May 2018 and December 2022. Among these patients, 118 consecutive limbs of 104 patients treated via repeat DCB for primary DCB restenosis were enrolled.ResultsThe Kaplan–Meier estimate of freedom from recurrent restenosis was 74.6% at 1 year. Cox proportional hazard multivariate analysis revealed that recurrent restenosis was independently associated with the time from initial DCB to primary restenosis (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.79–0.92; p < 0.001), history of ≥2 endovascular therapies (EVTs) (HR, 3.11; 95%CI, 1.36–7.12; p = 0.007), and PACSS grade 3 or 4 (HR, 2.76; 95%CI, 1.15–6.63; p = 0.023). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of the time from initial DCB to primary restenosis to prevent recurrent restenosis was 12.6 months, with an area under the curve of 0.841 (p < 0.001).ConclusionRepeat DCB therapy for DCB restenosis might be an acceptable strategy, particularly for restenosis that occurred more than 12.6 months after initial DCB, given the rate of freedom from recurrent restenosis.

中文翻译：

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股腘病变药物涂层球囊再狭窄重复药物涂层球囊治疗后复发性再狭窄的预测因素：RECURRENCE 研究结果


背景尽管药物涂层球囊（DCB）广泛用于治疗股腘（FP）病变，但对于 DCB 再狭窄的治疗策略仍没有达成共识。本研究旨在确定重复 DCB 治疗 FP 病变 DCB 再狭窄后复发再狭窄的危险因素。方法这项多中心回顾性研究评估了 860 名患者的 1176 个连续肢体，这些患者于 2018 年 5 月至 2018 年 5 月至 2018 年 5 月期间在四个心血管中心成功接受了针对 FP 病变的初始 DCB 治疗。 2022 年 12 月。在这些患者中，纳入了 104 名通过重复 DCB 治疗的原发性 DCB 再狭窄患者的 118 个连续肢体。结果 Kaplan-Meier 估计的 1 年时无复发性再狭窄的率为 74.6%。 Cox 比例风险多变量分析显示，复发性再狭窄与从初始 DCB 到初次再狭窄的时间独立相关（风险比 [HR]，0.85；95% 置信区间 [CI]，0.79–0.92；p < 0.001）、 ≥2 次血管内治疗 (EVT)（HR，3.11；95%CI，1.36–7.12；p = 0.007），以及 PACSS 3 或 4 级（HR，2.76；95%CI，1.15–6.63；p = 0.023）。此外，受试者工作特征曲线分析显示，从初始 DCB 到初次再狭窄以预防再狭窄复发的时间截止值为 12.6 个月，曲线下面积为 0.841 (p < 0.001)。结论 DCB 再狭窄重复 DCB 治疗考虑到再狭窄复发率，这可能是一种可接受的策略，特别是对于初次 DCB 后 12.6 个月以上发生的再狭窄。