Potent Statin Offers No Help After Cardiac Surgery
BARCELONA -- The powerful lipid-lowering drug rosuvastatin (Crestor) -- also purported to be an effective anti-inflammatory agent -- was powerless to prevent postoperative cardiac surgery complications such as atrial fibrillation in a randomized trial reported here.
About 21% of 960 patients who were treated with rosuvastatin 20 mg daily in in the perioperative period developed atrial fibrillation post surgery compared with 20% of 962 patients assigned to placebo (P=0.72), reported Barbara Casadei, MD, DPhil, professor of cardiovascular medicine at the University of Oxford.
The Statin Therapy in Cardiac Surgery (STICS) Trial enrolled more patients than the combined totals of 14 smaller studies -- a total of around 1,300 patients -- in an attempt to determine if statin therapy changed the incidence of cardiac complications after open heart surgery, Casadei said at a press conference at the annual congress of the European Society of Cardiology.
"Short term effects of statins -- so-called pleiotropic effects, which are very well documented with these drugs -- unfortunately do not seem to have an impact on patients' outcomes after elective cardiac surgery," she told MedPage Today.
She and her colleagues also looked at outcomes involving troponin I release, a marker of cardiac muscle injury, but again there was no hint that statin therapy had any impact on outcome when compared with placebo.
In the study, conducted in conjunction with researchers at Fu Wai Hospital in Beijing, patients were randomized to receive rosuvastatin or placebo up to 8 days prior to elective open-heart surgery, and the treatment was continued for 5 days after surgery. Patients were assessed for atrial fibrillation by 5-day Holter echocardiography and for myocardial injury by troponin assays.
"The STICS trial had a very high compliance -- 92% at the end of the trial," Casadei said. "Treatment with rosuvastatin was effective in reducing low density lipoprotein cholesterol (LDL) in the rosuvastatin treatment group already 48 hours after surgery. Nevertheless, the trial did not show any effect of rosuvastatin on postoperative atrial fibrillation or on any other outcome overall in the study, and in prespecified subgroups."
In commenting on the study, Paulus Kirchhof, MD, chair of cardiovascular medicine at the University of Birmingham, England, told MedPage Today, "Postoperative atrial fibrillation is an important complication of cardiac surgery. It increases cost, it increases hospital stay, and it happens to 20% to 30% of patients undergoing open-heart surgery. We always thought that postoperative atrial fibrillation is probably a condition where inflammation plays a major role -- because of opening the chest, because of cutting through the heart, there is a lot of inflammatory wound healing going on in the heart in the immediate postoperative period.
"We had small trials to suggest that coronary interventions with steroids or statins can have a dramatic effect on postoperative atrial fibrillation but we never had an adequately powered study to really confirm this," he noted.
"STICS enrolled more patients in one single trial than in all of the other trials combined before it," Kirchhof added. "It used a high-dose statin intervention; they demonstrated very clearly that they lowered LDL cholesterol, and they looked at outcomes such as postoperative atrial fibrillation and also at troponin release and complications. There was no difference whatsoever in any of the outcomes."
"The take-home message," said Casadei, "is that it is very important to use rosuvastatin or other statins in these patients in the long term to prevent cardiovascular events but not for preventing postoperative complications."
Source: www.medpagetoday.com
