title: Effects of oral cilostazol 100 mg BID on long-term patency after percutaneous transluminal angioplasty in patients with femoropopliteal disease undergoing hemodialysis: a retrospective chart review in Japanese patients.
abstract: BACKGROUND
  Percutaneous transluminal angioplasty (PTA) for femoropopliteal lesions in peripheral artery disease has been performed in patients undergoing hemodialysis as well as in the general population. Cilostazol, a selective inhibitor of phosphodiesterase 3, has been reported to reduce target lesion revascularization after PTA for femoropopliteal lesions in the general population.
  
  
  OBJECTIVE
  This study investigated the effects of cilostazol use on long-term patency after PTA in patients with femoropopliteal disease undergoing hemodialysis.
  
  
  METHODS
  In this retrospective study, data from patients undergoing hemodialysis who underwent successful PTA for femoropopliteal disease, defined as a final luminal diameter stenosis <30% without angiographically visual arterial dissection and no in-hospital complications, were included. One study group received long-term treatment with oral cilostazol 100 mg BID after PTA; the control group did not. The duration of follow-up was <or=6 years. The primary outcome of interest was cumulative patency, as measured by the event-free rate 6 years after PTA, with event defined as restenosis of >50% of the vessel diameter in femoropopliteal lesions. Data on baseline characteristics, patency, and covariates (diabetes, hypertension, hyperlipidemia, smoking, coronary artery disease, critical limb ischemia, TransAtlantic Inter-Society Consensus classification, and stenting) were obtained from electronic medical records and telephone interviews with patients. To minimize the effects of selection bias for cilostazol administration, a propensity-matched analysis using Cox univariate and multivariate models including the previously mentioned covariates was conducted. The propensity scores of the 2 groups were matched 1:1 (AUC = 0.69 [receiving operating characteristics analysis]). Data were obtained from electronic medical records and telephone interviews with patients by trained personnel who were blinded to treatment assignment.
  
  
  RESULTS
  A total of 358 consecutive lesions of 174 patients undergoing hemodialysis were included (103 men, 71 women; mean [SD] age, 66 [11] years; cilostazol group, 61 patients, 121 lesions; control group, 113 patients, 237 lesions). The mean duration of follow-up was 37 (27) months. The 6-year event-free rate of restenosis of >50% of the vessel diameter was significantly higher in the cilostazol group than in the control group (72/121 [59.5%] vs 120/237 [50.6%]; P = 0.005 [logrank test]; hazard ratio [HR] = 0.63; 95% CI, 0.45-0.88; P = 0.008 [Cox univariate analysis]). Also, event-free rates of target lesion revascularization and limb amputation were significantly higher in the cilostazol group than in the control group (40/61 [65.6%] vs 57/113 [50.4%]; P = 0.013 [log-rank test] and 54/61 [88.5%] vs 90/113 [79.6%]; P = 0.047 [logrank test], respectively). On propensity score matching (105 lesions), the baseline characteristics were comparable between the 2 groups. The 6-year eventfree rate of restenosis was significantly higher in the cilostazol group than in the control group (66/105 [62.9%] vs 52/105 [49.5%]; HR = 0.58; 95% CI, 0.38-0.88; P = 0.012 [Cox univariate analysis]). On propensity-matched (Cox multivariate) analysis, cilostazol (HR = 0.51; 95% CI, 0.27-0.84; P = 0.008), age (HR = 1.01; 95% CI, 1.01-1.04; P = 0.031), and critical limb ischemia (HR = 2.21; 95% CI, 1.39-3.53; P = 0.001) were independent predictors of restenosis. None of the patients in the cilostazol group discontinued cilostazol treatment during the follow-up period. Four patients (6.6%) experienced mild headache.
  
  
  CONCLUSIONS
  This study found that in these patients with femoropopliteal lesions in peripheral artery disease who were undergoing hemodialysis, those treated with cilostazol 100 mg BID after PTA had a higher mean rate of cumulative patency after PTA than those in the control group.
authors.affiliation: Cardiovascular Center, Nagoya Kyoritsu Hospital, Nagoya, Japan. hkishii@med.nagoya-u.ac.jp <hkishii@med.nagoya-u.ac.jp>
authors.forename: Hideki
authors.initials: H
authors.lastname: Ishii
authors.forename: Yoshitake
authors.initials: Y
authors.lastname: Kumada
authors.forename: Takanobu
authors.initials: T
authors.lastname: Toriyama
authors.forename: Toru
authors.initials: T
authors.lastname: Aoyama
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takahashi
authors.forename: Miho
authors.initials: M
authors.lastname: Tanaka
authors.forename: Daisuke
authors.initials: D
authors.lastname: Kamoi
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kawamura
authors.forename: Shigeki
authors.initials: S
authors.lastname: Yamada
authors.forename: Mutsuharu
authors.initials: M
authors.lastname: Hayashi
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Yasuda
authors.forename: Yukio
authors.initials: Y
authors.lastname: Yuzawa
authors.forename: Shoichi
authors.initials: S
authors.lastname: Maruyama
authors.forename: Seiichi
authors.initials: S
authors.lastname: Matsuo
authors.forename: Tatsuaki
authors.initials: T
authors.lastname: Matsubara
authors.forename: Toyoaki
authors.initials: T
authors.lastname: Murohara
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000379:methods*; D044466:Asian People; D000077407:Cilostazol; D005260:Female; D005263:Femoral Artery / Q000187:drug effects* / Q000473:pathology; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy; D008297:Male; D016555:Matched-Pair Analysis; D008499:Medical Records; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000453:epidemiology / Q000628:therapy*; D011150:Popliteal Artery / Q000187:drug effects* / Q000473:pathology; D006435:Renal Dialysis / Q000379:methods; D012189:Retrospective Studies; D013777:Tetrazoles / Q000008:administration & dosage* / Q000494:pharmacology; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage* / Q000494:pharmacology
chemical_list: D013777:Tetrazoles; D014665:Vasodilator Agents; D000077407:Cilostazol