Clinical outcomes and risk factors associated with drug-coated balloon treatment for femoropopliteal artery disease in patients on maintenance hemodialysis

Abstract Background Hemodialysis (HD) patients, who are at high risk for atherosclerosis including peripheral artery disease, are associated with poor clinical outcomes after endovascular therapy. Although recent clinical trials have reported favorable outcomes after drug-coated balloon (DCB) treatment for femoropopliteal lesions, its usefulness and risk factors in HD patients have not been well elucidated. Purpose This study aimed to investigate clinical outcomes and the associated risk factors after DCB treatment in HD patients with femoropopliteal lesions. Methods This study included 140 HD patients with their 185 femoropopliteal lesions that underwent DCB treatment between September 2018 and January 2022. Non-HD patients and cases of acute limb ischemia were excluded. The endpoints were 1-year freedom from restenosis and clinically driven target lesion revascularization (CD-TLR). The risk factors were also evaluated. Result Duration of maintenance hemodialysis in all patients was 8.6 years. Mean lesion length was 11.0±6.9 cm, and rates of chronic total occlusion and severe calcification were 17.3% and 45.4%, respectively. Types of DCB were IN.PACT Admiral (22.9%), Lutonix (50.8%) and Ranger (24.3%). Bail-out stenting was performed in 1.1% of all lesions. The Kaplan-Meier estimate of freedom from restenosis and CD-TLR were 63.8% and 71.3% at 12 months, respectively. The freedom rates from CD-TLR after high-dose and low-dose DCB therapy were 79.4% and 66.4%, respectively (p=0.095). Risk factors independently associated with 1-year CD-TLR were diabetes [hazard ratio (HR) 2.30, 95% confidence interval (CI) 1.03-5.15, p=0.043], chronic limb-threatening ischemia (HR 1.93, 95%CI 1.05-3.53, p=0.035) and sever calcification (HR 2.42, 95%CI 1.39-4.21, p=0.0019). When patients were divided into groups according to number of these three risk factors, the rates of freedom from CD-TLR at 12 months were 100%, 94.8%, 76.7% and 30.3% among groups with no risk factor, any 1 risk factor, any 2 risk factors and all risk factors, respectively (p<0.0001). Conclusion The 1-year clinical outcomes after DCB treatment in HD patients with femoropopliteal lesions were unsatisfactory. Independent risk factors for 1-year CD-TLR were diabetes, chronic limb-threatening ischemia and severe calcification.