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STICS: Statin therapy does not impact AF, myocardial injury in elective cardiac surgery
In patients undergoing elective cardiac surgery, the use of perioperative statin treatment did not prevent postoperative atrial fibrillation or myocardial injury, and increased risk for acute kidney injury, according to recent findings.
In the randomized, placebo-controlled STICS trial, researchers evaluated 1,922 adult patients scheduled to undergo elective CABG, surgical aortic valve replacement or both between September 2011 and October 2013. Patients identified for inclusion were in sinus rhythm and were not taking any antiarrhythmic drugs.
Participants underwent transthoracic echocardiography to assess left ventricular ejection fraction and left atrial size. Blood was taken from the patients to test for levels of troponin I, N-terminal pro–B-type natriuretic peptide, creatinine, LDL and high-sensitivity C-reactive protein. Patients were randomly assigned rosuvastatin (Crestor, AstraZeneca) 20 mg once daily (n = 960) or placebo (n = 962) for up to 8 days preoperatively and for 5 days postoperatively.
The prespecified co-primary endpoints were postoperative AF within 5 days and myocardial injury within 120 hours of surgery. Continuous Holter electrocardiographic monitoring was used to detect postoperative AF within 5 days after surgery, and area under the curve of troponin I release was measured to assess perioperative myocardial injury.
The researchers analyzed the co-primary endpoints in subgroups defined by baseline age, sex, previous statin use, troponin I level, duration of randomized preoperative regimen, type of surgery and postoperative use of nonsteroidal anti-inflammatory drugs or glucocorticoids.
The researchers found that, postoperatively, both groups experienced a decrease in LDL levels. However, patients assigned to the rosuvastatin group had lower levels of LDL and high-sensitivity CRP vs. controls (P < .001).
No difference in outcomes
Of the 1,874 patients who underwent surgery, 5-day continuous postoperative Holter electrocardiographic data were available for 1,834 patients (98%). Four hundred patients were found to have postoperative AF, and this was sustained in 368 (92%) of these patients. No association was seen between rosuvastatin and lower rates of AF vs. placebo, with 203 (21%) postoperative AF patients in the rosuvastatin group and 197 (20%) in the placebo group (OR = 1.04; 95% CI, 0.84-1.3). Moreover, rosuvastatin did not significantly affect the rate of postoperative AF in any of the prespecified subgroups. Notably, rosuvastatin did not yield a lower prevalence of postoperative AF among the 743 participants who began the trial regimen more than 2 days before surgery.
In terms of the co-primary outcome of myocardial injury, rosuvastatin did not have a significant effect on postoperative troponin I release, with an area under the troponin release curve of 102 ng x hour/mL in the rosuvastatin group vs. 100 ng x hour/mL in the placebo group (between-group difference, 1%; 95% CI, –9 to 13; P = .8).
The researchers found no significant association between rosuvastatin and any of the secondary outcomes pertaining to myocardial injury, and rosuvastatin was not linked to lower risk for myocardial injury vs. placebo in any of the subgroups.
Risk for kidney injury
There was a higher prevalence of acute kidney injury in the rosuvastatin group vs. placebo (absolute excess, 5.4 plus or minus 1.9 percentage points; P = .005). Although most of this excess was stage I acute kidney injury, a significant excess of stage II or III acute kidney injury also was observed (absolute excess, 1.8 plus or minus 0.7 percentage points; P = .02).
“Despite promising observations in experimental studies and small clinical trials,we found that perioperative statin therapy did not prevent postoperative [AF] or perioperative myocardial damage in patients undergoing elective cardiac surgery,” the researchers wrote. “Given the lack of good evidence of beneficial effects of perioperative statin therapy in our trial, the adverse effects on renal function warrant careful consideration.” – by Jennifer Byrne
Disclosure: The study was funded in part by a small unrestricted grant from AstraZeneca. Please see the full study for a list of all the researchers’ relevant financial disclosures.