諾華藥廠、荷蘭健康研究與發展組織、Erasmus醫學中心、Stichting Lijfen Leven與荷蘭心臟醫學會贊助這項研究。試驗作者中有三位表示接受Medtronic、Cardialysis、Boston Scientific、 Bristol-Myers Squibb Medical Imaging、St. Jude Medical、GE Healthcare、Edwards Life Science、Novartis以及/或是與Merck公司有資金上的往來。
Perioperative Fluvastatin May Improve Cardiac Outcomes After Vascular Surgery
By Laurie Barclay, MD
Medscape Medical News
September 16, 2009 — Perioperative treatment with fluvastatin may improve cardiac outcomes after vascular surgery, according to the results of a double-blind, placebo-controlled trial reported in the September 3 issue of the New England Journal of Medicine.
"Adverse cardiac events are common after vascular surgery," write Olaf Schouten, MD, PhD, from Erasmus Medical Center, Rotterdam, the Netherlands, and colleagues from the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group (DECREASE III). "We hypothesized that perioperative statin therapy would improve postoperative outcomes."
Patients who had not previously been treated with a statin were randomly assigned to receive either 80 mg of extended-release fluvastatin or placebo once daily, in addition to a beta-blocker, before undergoing vascular surgery. At the time of randomization and before surgery, patients had measurements of lipid, interleukin-6, and C-reactive protein levels.
The main outcome of the study was myocardial ischemia occurring within 30 days after surgery, which was defined as transient electrocardiographic abnormalities, release of troponin T, or both. The secondary outcome measure was a composite of death from cardiovascular causes and nonfatal myocardial infarction.
At a median of 37 days before vascular surgery, 250 patients were randomly assigned to fluvastatin treatment and 247 patients to placebo. In the fluvastatin group, but not in the placebo group, total cholesterol, low-density lipoprotein cholesterol, interleukin-6, and C-reactive protein levels were significantly decreased.
The primary endpoint of postoperative myocardial ischemia occurred in 27 patients (10.8%) in the fluvastatin group vs 47 (19.0%) in the placebo group (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.34 - 0.88; P = .01). The secondary composite outcome of 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 (HR, 0.47; 95% CI, 0.24 - 0.94; P = .03).
"Fluvastatin therapy was not associated with a significant increase in the rate of adverse events," the study authors write. "In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome."
A limitation of the study was that the trial lacked statistical power for the composite outcome of risk for death from cardiovascular causes or nonfatal myocardial infarction.
"Recent guidelines from the American College of Cardiology and the American Heart Association (ACC–AHA) and the TransAtlantic Inter-Society Consensus on the management of peripheral arterial disease indicate that statin use is appropriate in patients undergoing vascular surgery, regardless of whether they have other clinical risk factors," the study authors conclude. "These guidelines are based on retrospective studies; the results of the current prospective trial confirm these recommendations."
Novartis, the Netherlands Organization for Health Research and Development, Erasmus Medical Center, Stichting Lijfen Leven, and the Netherlands Heart Foundation supported this study. Three of the study authors have disclosed various financial relationships with Medtronic, Cardialysis, Boston Scientific, Bristol-Myers Squibb Medical Imaging, St. Jude Medical, GE Healthcare, Edwards Life Science, Novartis, and/or Merck.
