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Atorvastatin provides neutral results in patients undergoing noncardiac surgery
Statin-naive, high-risk patients undergoing noncardiac surgery did not experience a lower risk for major postoperative vascular events with atorvastatin, according to findings published in the American Heart Journal.
“Similar to the [Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose] results, previous systematic review of these trials found nonsignificant trend toward lower vascular events and, due to the lack of statistical power, concluded that the available evidence is not sufficient to define the effectiveness or safety of using statins to prevent major vascular events,” Otavio Berwanger, MD, PhD, director of the Research Institute–Hospital do Coracao in Sao Paulo, and colleagues wrote.
Researchers enrolled 648 patients (mean age, 66.7 years; 61.9% women) undergoing noncardiac surgery from April 2013 to June 2015. Patients met various criteria, including a history of CAD, peripheral vascular disease, stroke and other risk factors.
Up to 18 hours before surgery, patients were randomly assigned 80 mg atorvastatin (n = 328) or placebo (n = 320). Postoperatively, they received 40 mg atorvastatin or placebo, which was repeated daily for the next 7 days.
The primary outcome was a combination of stroke, nonfatal myocardial injury after noncardiac surgery and all-cause mortality 30 days after randomization. Secondary efficacy outcomes were a combination of MI, total death, pulmonary embolism, deep vein thrombosis, CV death or any elements of the primary outcome. Secondary safety outcomes were an increase of liver enzymes (> 10 x upper limit of normal) or creatine phosphokinase (> 10 x upper limit of normal) the first 7 days after the procedure or the existence of rhabdomyolysis or myalgia 30 days after surgery.
Fifty-four patients (16.6%) assigned atorvastatin experienced the primary composite outcome vs. 59 patients (18.7%) assigned placebo (HR = 0.87; 95% CI, 0.6-1.26). The first 5 days after surgery was when most of the events (86.7%) transpired.
There were no major differences between the atorvastatin group and the placebo group for the secondary efficacy and safety outcomes. MI and all-cause death were observed in 24 (7.4%) of patients who were administered atorvastatin vs. 26 patients (8.2%) who received placebo (HR = 0.86; 95% CI, 0.49-1.5). Forty-three patients (13.2%) who received atorvastatin and 52 patients (16.5%) with placebo experienced myocardial injury after noncardiac surgery (HR = 0.79; 95% CI, 0.53-1.19). MI occurred in 11 patients (3.4%) who were administered atorvastatin vs. 14 patients (4.4%) in the placebo group (HR = 0.76; 95% CI, 0.35-1.68). The atorvastatin group experienced 14 deaths (4.3%) while the placebo group had 13 (4.1%; P = .74). No strokes were observed in the placebo group vs. the three patients (0.9%) in the other group (P = .25).
Although the study produced neutral results, Berwanger and colleagues wrote that the results provide an opportunity for future research.
“We demonstrated, however, that a large, multicenter, blinded perioperative statin trial for high-risk, statin-naive patients is feasible, and therefore, our findings might help to better inform the design of future well-powered clinical outcomes trial to definitely establish the efficacy and safety of statin in this patient population,” Berwanger and colleagues wrote. – by Darlene Dobkowski
Disclosure: The researchers report no relevant financial disclosures.