Fluvastatin and perioperative events in patients undergoing vascular surgery.

Full 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.) Massachusetts Medical Society

Author information

Author/s: Schouten, Olaf (O); 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); Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group;

Affiliation: Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.

Journal and publication information

Publication Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: The New England journal of medicine (N Engl J Med), published in United States. (Language: eng)

Reference: 2009-Sep; vol 361 (issue 10) : pp 980-9

Dates: Created 2009/09/03; Completed 2009/09/09;

PMID: 19726772, status: MEDLINE (last retrieval date: 9/9/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; therapeutic use
Indoles - adverse effects; therapeutic use
Interleukin-6 - blood
Kaplan-Meiers Estimate
Myocardial Ischemia - epidemiology; prevention & control
Perioperative Care
Postoperative Period
Troponin T - blood
Vascular Surgical Procedures

Associated Chemicals: Adrenergic beta-Antagonists (0) ; Fatty Acids, Monounsaturated (0) ; Hydroxymethylglutaryl-CoA Reductase Inhibitors (0) ; Indoles (0) ; Interleukin-6 (0) ; Troponin T (0) ; Cholesterol (57-88-5) ; C-Reactive Protein (9007-41-4) ; fluvastatin (93957-54-1)

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