title: Fluvastatin and perioperative events in patients undergoing vascular surgery.
abstract: BACKGROUND
  Adverse cardiac events are common after vascular surgery. We hypothesized that perioperative statin therapy would improve postoperative outcomes.
  
  
  METHODS
  In this double-blind, placebo-controlled trial, we randomly assigned patients who had not previously been treated with a statin to receive, in addition to a beta-blocker, either 80 mg of extended-release fluvastatin or placebo once daily before undergoing vascular surgery. Lipid, interleukin-6, and C-reactive protein levels were measured at the time of randomization and before surgery. The primary end point was the occurrence of myocardial ischemia, defined as transient electrocardiographic abnormalities, release of troponin T, or both, within 30 days after surgery. The secondary end point was the composite of death from cardiovascular causes and myocardial infarction.
  
  
  RESULTS
  A total of 250 patients were assigned to fluvastatin, and 247 to placebo, a median of 37 days before vascular surgery. Levels of total cholesterol, low-density lipoprotein cholesterol, interleukin-6, and C-reactive protein were significantly decreased in the fluvastatin group but were unchanged in the placebo group. Postoperative myocardial ischemia occurred in 27 patients (10.8%) in the fluvastatin group and in 47 (19.0%) in the placebo group (hazard ratio, 0.55; 95% confidence interval [CI], 0.34 to 0.88; P=0.01). Death from cardiovascular causes or myocardial infarction occurred in 12 patients (4.8%) in the fluvastatin group and 25 patients (10.1%) in the placebo group (hazard ratio, 0.47; 95% CI, 0.24 to 0.94; P=0.03). Fluvastatin therapy was not associated with a significant increase in the rate of adverse events.
  
  
  CONCLUSIONS
  In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome. (Current Controlled Trials number, ISRCTN83738615.)
authors.affiliation: Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Olaf
authors.initials: O
authors.lastname: Schouten
authors.forename: Eric
authors.initials: E
authors.lastname: Boersma
authors.forename: Sanne E
authors.initials: SE
authors.lastname: Hoeks
authors.forename: Robbert
authors.initials: R
authors.lastname: Benner
authors.forename: Hero
authors.initials: H
authors.lastname: van Urk
authors.forename: Marc R H M
authors.initials: MR
authors.lastname: van Sambeek
authors.forename: Hence J M
authors.initials: HJ
authors.lastname: Verhagen
authors.forename: Nisar A
authors.initials: NA
authors.lastname: Khan
authors.forename: Martin
authors.initials: M
authors.lastname: Dunkelgrun
authors.forename: Jeroen J
authors.initials: JJ
authors.lastname: Bax
authors.forename: Don
authors.initials: D
authors.lastname: Poldermans
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D002097:C-Reactive Protein / Q000032:analysis; D002318:Cardiovascular Diseases / Q000401:mortality; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D004562:Electrocardiography; D005229:Fatty Acids, Monounsaturated / Q000009:adverse effects / Q000627:therapeutic use*; D000077340:Fluvastatin; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D015850:Interleukin-6 / Q000097:blood; D053208:Kaplan-Meier Estimate; D017202:Myocardial Ischemia / Q000453:epidemiology / Q000517:prevention & control*; D019990:Perioperative Care; D011184:Postoperative Period; D020107:Troponin T / Q000097:blood; D014656:Vascular Surgical Procedures
chemical_list: D000319:Adrenergic beta-Antagonists; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D015850:Interleukin-6; D020107:Troponin T; D000077340:Fluvastatin; D002097:C-Reactive Protein; D002784:Cholesterol