title: Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease.
abstract: BACKGROUND
  Clinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently.
  
  
  METHODS
  This retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up.
  
  
  RESULTS
  Most of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50-782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis.
  
  
  CONCLUSIONS
  Despite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation, Taipei, Taiwan.
authors.forename: Shih-Jung
authors.initials: SJ
authors.lastname: Jang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation, Taipei, Taiwan.
authors.forename: Chien-An
authors.initials: CA
authors.lastname: Hsieh
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation, Taipei, Taiwan.
authors.forename: Hsuan-Li
authors.initials: HL
authors.lastname: Huang
authors.affiliation: Cardiovascular Center and Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Jyh-Ming Jimmy
authors.initials: JM
authors.lastname: Juang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation, Taipei, Taiwan.|School of Medicine, Tzuchi University, Hualien, Taiwan.
authors.forename: Hsin-Hua
authors.initials: HH
authors.lastname: Chou
authors.affiliation: Department of Industrial and Business Management, Chang Gang University, Taoyuan, Taiwan.
authors.forename: Chueh-Yung
authors.initials: CY
authors.lastname: Tsao
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation, Taipei, Taiwan.
authors.forename: Tien-Yu
authors.initials: TY
authors.lastname: Wu
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation, Taipei, Taiwan.|School of Medicine, Tzuchi University, Hualien, Taiwan.
authors.forename: Yu-Lin
authors.initials: YL
authors.lastname: Ko
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D003430:Cross-Sectional Studies; D005121:Extremities / Q000473:pathology / Q000601:surgery; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000188:drug therapy* / Q000601:surgery*; D011150:Popliteal Artery / Q000473:pathology / Q000601:surgery; D012189:Retrospective Studies; D016896:Treatment Outcome; D062666:Vascular Access Devices