Hsieh Chien-An, Chou Shing-Hsien, Chen I-Chih, Jang Shih-Jung, Chou Hsin-Hua, Ko Yu-Lin, Huang Hsuan-Li
Division of Cardiology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City.
Department of Cardiology, Chang-Gung Memorial Hospital.
Acta Cardiol Sin. 2019 May;35(3):308-319. doi: 10.6515/ACS.201905_35(3).20181116A.
The efficacy of drug-coated balloons (DCBs) in critical limb ischemia (CLI) is unclear. To investigate the clinical characteristics and outcomes of DCBs in symptomatic femoropopliteal disease between patients with intermittent claudication (IC) and CLI.
Data were retrospectively collected from three centers in Taiwan on patients who received DCBs for femoropopliteal lesions between March 2013 and June 2017. We compared the clinical characteristics and outcomes regarding binary restenosis, amputation-free survival (AFS), and major adverse limb events (MALEs) between groups. Cox proportional hazards analysis was used to identify predictors of outcome endpoints.
We enrolled a total of 200 affected limbs in 174 patients, including 83 limbs in 71 patients with IC and 117 limbs in 103 patients with CLI. Compared to the patients with claudication, those with CLI were older and had higher proportions of medical comorbidities, tissue inflammation, poor runoff, and vessel calcification. The 3-year rates of freedom from binary restenosis (57% vs. 59%, p = 0.781), and MALEs (77% vs. 67%, p = 0.507) were similar between the two groups. However, the 3-year AFS was significantly higher in the IC group compared to the CLI group (91% vs. 73%, p = 0.001). Lesion length and severe calcification independently predicted binary restenosis, and restenotic lesion predicted MALEs. Age, congestive heart failure, and dialysis were independently associated with AFS.
Despite advanced limb ischemia and comorbidities, the mid-term outcomes in surviving CLI patients were similar to those in the IC patients after treatment with DCBs for femoropopliteal disease.
药物涂层球囊（DCB）在严重肢体缺血（CLI）中的疗效尚不清楚。旨在研究间歇性跛行（IC）和CLI患者中DCB治疗有症状股腘动脉疾病的临床特征及结局。
回顾性收集台湾三个中心2013年3月至2017年6月间接受DCB治疗股腘动脉病变患者的数据。我们比较了两组间关于二元再狭窄、无截肢生存（AFS）和主要肢体不良事件（MALE）的临床特征及结局。采用Cox比例风险分析来确定结局终点的预测因素。
我们共纳入了174例患者的200条患肢，其中71例IC患者的83条肢体，以及103例CLI患者的117条肢体。与跛行患者相比，CLI患者年龄更大，合并症、组织炎症、血流不佳和血管钙化的比例更高。两组间二元再狭窄的3年无复发率（57%对59%，p = 0.781）和MALE（77%对67%，p = 0.507）相似。然而，IC组的3年AFS显著高于CLI组（91%对73%，p = 0.001）。病变长度和严重钙化独立预测二元再狭窄，而再狭窄病变预测MALE。年龄、充血性心力衰竭和透析与AFS独立相关。
尽管存在严重肢体缺血和合并症，但在接受DCB治疗股腘动脉疾病后，存活的CLI患者的中期结局与IC患者相似。
