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| |  Fluvastatin Extended Release Associated With Improved Cardiac Outcome After Major Vascular Surgery: Presented at ESC By Chris Berrie MUNICH, Germany -- September 2, 2008 -- Perioperative administration of fluvastatin extended release (XL) is safe and associated with a reduced incidence of myocardial ischaemia, myocardial infarction (MI), and cardiac death in statin-naïve patients undergoing major noncardiac vascular surgery, according to a randomised, double-blind, placebo-controlled trial. Don Poldermans, MD, PhD, Department of Vascular Surgery, Erasmus Medical Centre, Rotterdam, Netherlands, presented the study results on behalf of the Dutch Echographic Cardiac Risk Evaluation Applying Stress Echo III investigators here at the European Society of Cardiology 2008 Congress (ESC). "Some very large retrospective studies have shown the beneficial effects of statins during surgery, so it was our hypothesis that perioperative statin use reduces the incidence of cardiovascular complications in vascular surgery, the high-risk surgery patients," Dr. Poldermans said in a presentation on August 31. The study enrolled high-risk surgery patients who were scheduled to undergo noncardiac vascular surgery, with reasons including abdominal aortic aneurysm, abdominal aortic stenosis, lower limb stenosis, and carotid artery stenosis. Exclusion criteria were current statin use or contraindications for statin use, plus a range of surgical specifications. The primary endpoint was myocardial ischaemia, as specified via continuous (to 72 hours postoperative) or repeated (days 7 and 30) electrocardiograms, or troponin T measures (on days 1, 3, 7, and 30). The secondary endpoint was a composite of cardiovascular (CV) death or nonfatal MI within 30 days of surgery. Patients were randomised to receive either placebo (n = 247) or fluvastatin XL 80 mg QD (n = 250). Treatment was started on the day of randomisation, at a median of 37 days prior to surgery, and was continued for 30 days after surgery. Mean ages in the 2 groups were 65.7 and 65.8 years, respectively, and males made up 72% and 77% of patients in the 2 groups, respectively. Baseline characteristics showed no differences between the treatment groups. Similarly, both groups were on optimal perioperative medication, which mainly included beta-blockers (100% of patients in each group) and antiplatelet therapy (60% of patients in each group). Both inflammation status and cholesterol levels were identical in the 2 groups at baseline, Dr. Poldermans said. Immediately prior to surgery, changes for the active treatment group over placebo included significant reductions in levels of total cholesterol (-20%; P < .001), low-density lipoprotein cholesterol (-21%; P < .001), high-sensitivity C-reactive protein (-21%; P < .001), and interleukin-6 (-33%; P < .001). With fluvastatin treatment, there was a significant reduction in myocardial ischaemia (odds ratio [OR], 0.53; P = .016), as also seen for CV death or nonfatal MI (OR, 0.48; P = .039). Dr. Poldermans noted that fluvastatin was not associated with any increase in incidence of adverse effects, liver dysfunction, or myopathy. "You might recommend fluvastatin to start prior to surgery in high-risk vascular patients undergoing surgery," he concluded
[Presentation title: Fluvastatin XL Use Is Associated With Improved Cardiac Outcome After Major Vascular Surgery. Results From a Randomised, Placebo-Controlled Trial: DECREASE III. Abstract 1688]
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