Fluvastatin and perioperative events in patients undergoing vascular surgery.
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.)
Schouten
Olaf
O
Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.
Boersma
Eric
E
Hoeks
Sanne E
SE
Benner
Robbert
R
van Urk
Hero
H
van Sambeek
Marc R H M
MR
Verhagen
Hence J M
HJ
Khan
Nisar A
NA
Dunkelgrun
Martin
M
Bax
Jeroen J
JJ
Poldermans
Don
D
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
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