title: Addition of cilostazol to aspirin therapy for secondary prevention of cardiovascular and cerebrovascular disease in patients undergoing percutaneous coronary intervention: A randomized, open-label trial.
abstract: BACKGROUND
  Patients with established coronary artery disease are at increased risk for future ischemic events and require secondary prevention for systemic vascular disease. We performed a randomized clinical trial to evaluate the impact of cilostazol on cardiovascular and cerebrovascular disease in patients undergoing percutaneous coronary intervention.
  
  
  METHODS
  A total of 514 patients who had undergone coronary stent implantation >6 months previously and were thought to no longer need dual antiplatelet therapy with aspirin and a thienopyridine were randomly assigned to receive aspirin plus cilostazol therapy or aspirin therapy alone after discontinuation of thienopyridine therapy. The primary efficacy end point was a composite of all-cause death, myocardial infarction, stroke, or cardiovascular or cerebrovascular revascularization at 2 years after randomization. The main safety end point was major or minor bleeding, according to the Thrombolysis in Myocardial Infarction bleeding definition.
  
  
  RESULTS
  At 2 years, follow-up clinical data were available for 98.1% of patients. The primary efficacy end point occurred in 13.9% of the aspirin plus cilostazol group versus 22.1% of the aspirin-only group (hazard ratio 0.61, 95% CI 0.40-0.93, P = .021). The rate of major or minor bleeding was not significantly different between the aspirin plus cilostazol and aspirin-only groups (1.6% and 4.0%, respectively, hazard ratio 0.40, 95% CI 0.13-1.28, P = .12).
  
  
  CONCLUSIONS
  In patients who underwent coronary stent implantation, the addition of cilostazol to aspirin therapy was associated with lower rates of cardiovascular and cerebrovascular events at 2 years compared with aspirin monotherapy.
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan. Electronic address: h.ueda998@nifty.com.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueda
authors.affiliation: Department of Cardiovascular Medicine, Komatsu Hospital, Neyagawa, Japan.
authors.forename: Atsumichi
authors.initials: A
authors.lastname: Kido
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Matsuhisa
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Asawa
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Yoshida
authors.affiliation: Department of Cardiovascular Medicine, Veritas Hospital, Kawanishi, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Tsujimoto
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sasaki
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Kuga
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Yamasaki
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan.
authors.forename: Kazuya
authors.initials: K
authors.lastname: Ueda
authors.affiliation: Department of Cardiovascular Medicine, Kitajima Taoka Hospital, Itano, Japan.
authors.forename: Shoichi
authors.initials: S
authors.lastname: Shinohara
authors.affiliation: Department of Cardiovascular Medicine, Takai Hospital, Tenri, Japan.
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Nishida
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage*; D002561:Cerebrovascular Disorders / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D000077407:Cilostazol; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D055502:Secondary Prevention / Q000379:methods*; D013777:Tetrazoles / Q000008:administration & dosage*; D013923:Thromboembolism / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077407:Cilostazol; D001241:Aspirin