title: Spironolactone does not prevent restenosis after coronary stenting in humans.
abstract: BACKGROUND
  In animal studies, aldosterone enhanced neointimal proliferation by increasing extracellular accumulation of collagen and potentiating the effects of angiotensin II. Spironolactone, an aldosterone antagonist, is a potent inhibitor of neointimal proliferation. We conducted a placebo-controlled, double-blind, randomised study to assess the effect of spironolactone on angiographic 6-month in-stent restenosis.
  
  
  METHODS
  Of the 310 randomised patients with significant coronary artery disease, 258 patients were available for analysis: 128 constituted the placebo group and 130 were assigned to receive spironolactone. Eligible patients were randomly assigned to receive a dose of 50 mg spironolactone or placebo orally twice a day for 6 months. The primary endpoint was the angiographic restenosis (>50% stenosis) rate at follow-up angiography.
  
  
  RESULTS
  At 6-month follow-up angiography after stenting, there was no difference between the 2 groups in minimal lumen diameter, percent diameter stenosis, late loss, and net gain. Angiographic restenosis occurred in 46 (35.4%) of 130 patients receiving spironolactone and 50 (39.0%) of 128 in the placebo group with an odds ratio (OR) of 0.85 with a 95% confidence interval (CI) of 0.49 to 1.46 (P = 0.62). Restenosis rate was found in 60 (32.9%) of 182 lesions in the spironolactone group, and 61 (35.5%) of 172 lesions in the placebo group with an OR of 0.89 with a 95% CI of 0.56 to 1.42 (P = 0.89).
  
  
  CONCLUSIONS
  Spironolactone did not reduce the incidence of in-stent restenosis as compared with placebo in human, contrary to the fact that reduction of neointimal formation in animal models has been observed upon administration of spironolactone.
authors.affiliation: Cardiac Catheterization Laboratory, Department of Cardiology, Gulhane Military Medical Academy, Turkey. shurkan@superonline.com
authors.forename: H
authors.initials: H
authors.lastname: Kursaklioglu
authors.forename: A
authors.initials: A
authors.lastname: Iyisoy
authors.forename: B
authors.initials: B
authors.lastname: Amasyali
authors.forename: T
authors.initials: T
authors.lastname: Celik
authors.forename: C
authors.initials: C
authors.lastname: Ozturk
authors.forename: S
authors.initials: S
authors.lastname: Kose
authors.forename: E
authors.initials: E
authors.lastname: Isik
mesh_terms: D000328:Adult; D000368:Aged; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D013148:Spironolactone / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D013148:Spironolactone