Abstract

Introduction: Although there is robust evidence for the superiority of contemporary femoropopliteal (FP)-specific devices to traditional therapy using non-coated balloon or bare metal stent, cohesive reports on the incidence of acute thrombotic occlusion (ATO) after endovascular therapy (EVT) with contemporary FP devices are scarce. This study investigated the incidence of ATO and its predictors after contemporary FP-EVT for peripheral artery disease. Methods: We retrospectively examined 763 limbs (chronic limb-threatening ischemia [CLTI]: 44%, involving popliteal arterial lesion: 44%) in 644 patients (mean age: 75±9 years, male: 71%, hemodialysis: 34%) who successfully underwent EVT with contemporary FP devices (drug-coated balloon [DCB]: n=235, scaffold: n=528 [drug-coated stent: n=220, stent graft: n=158, drug-eluting stent: n=150]) from June 2012 to July 2020. The outcome measure was ATO defined as acute onset of claudication and/or signs of CLTI in combination with angiographic evidence of occlusive thrombus formation within the treated segment. Cox proportional hazards regression models were used to identify baseline characteristics associated with the incidence of ATO after contemporary FP-EVT. Results: The 24-month incidence of ATO in the overall population was 4.3±0.8% (DCB: 1.0±0.7% versus scaffold: 5.8±1.1%, P<.01). Due to the remarkably lower incidence of ATO after EVT with DCB, risk factors for ATO in patients treated with scaffold was identified. Hemodialysis (hazard ratio [HR]: 2.63, P=.02) and involving popliteal lesion (HR: 8.22, P<.01) were independently associated with an increased risk of ATO. The 24-month incidence of ATO in patients with those risk factors was 21.0±3.3%, while that in patients without those factors was 0.5±0.2%. Conclusions: We found a substantial incidence of ATO after contemporary FP-EVT, particularly with scaffold. Hemodialysis and involving popliteal lesion were significantly associated with ATO risk in patients treated with scaffold. The scaffold was safely used in patients without those risk factors of ATO, but a non-scaffolding strategy, including surgical bypass therapy, should be considered for patients with those risk factors.

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