title: Cilostazol reduces restenosis after endovascular therapy in patients with femoropopliteal lesions.
abstract: BACKGROUND
  Despite the recent development of endovascular therapy (EVT), a high incidence of restenosis remains as an unsolved issue in patients presenting with femoropopliteal lesions. We investigated whether cilostazol reduces restenosis after successful EVT for de novo femoropopliteal lesions.
  
  
  METHODS
  This study was designed as a prospective, randomized, open-label, blinded end point study in a single institution. Between March 2004 and June 2005, we randomized 127 patients who were successfully treated with EVT for de novo femoropopliteal lesions to receive cilostazol (200 mg/d, n = 63) or ticlopidine (200 mg/d, n = 64) in addition to aspirin (100 mg/d). Antiplatelet medications were started at least 1 week before EVT and were continued until the end of follow-up. Patency was defined by duplex ultrasound imaging with peak systolic velocity ratio >2.4.
  
  
  RESULTS
  There were no significant differences in the patients and lesion characteristics. Sixteen patients dropped out of the study protocol, six of whom were withdrawn due to adverse drug effects (cilostazol, n = 5; ticlopidine, n = 1; P = .09). Ten patients died (cilostazol, n = 4; ticlopidine, n = 6; P = .53) during the follow-up period. Patency rates at 12, 24, and 36 months were 87%, 82%, and 73% in the cilostazol group and 65%, 60%, and 51% in ticlopidine group by intention-to-treat analysis (P = .013) and were 87%, 82%, and 73% in the cilostazol group and 64%, 57%, and 48% in the ticlopidine group (P = .0088) by as-treated analysis. Freedom from target lesion revascularization and all adverse events (restenosis, amputation, and death) was significantly higher in cilostazol group than in ticlopidine group (P = .036, P = .031). No acute, subacute, or chronic thrombotic occlusion was encountered, and bleeding complication rates were similar between the two groups.
  
  
  CONCLUSIONS
  Cilostazol significantly reduces restenosis after EVT in femoropopliteal lesions.
authors.affiliation: Cardiovascular Division, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan. osa-iida@nifty.com
authors.forename: Osamu
authors.initials: O
authors.lastname: Iida
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Nanto
authors.forename: Masaaki
authors.initials: M
authors.lastname: Uematsu
authors.forename: Takakazu
authors.initials: T
authors.lastname: Morozumi
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kitakaze
authors.forename: Seiki
authors.initials: S
authors.lastname: Nagata
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D000077407:Cilostazol; D005260:Female; D005263:Femoral Artery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D011446:Prospective Studies; D015607:Stents; D013777:Tetrazoles / Q000627:therapeutic use*; D014665:Vasodilator Agents / Q000627:therapeutic use*
chemical_list: D013777:Tetrazoles; D014665:Vasodilator Agents; D000077407:Cilostazol