International guidelines on preventing atrial fibrillation could change after a major trial raised questions about the benefits of taking statins before and after heart surgery.
Doctors behind the international Statin Therapy In Cardiac Surgery (STICS) trial, which was led by the University of Oxford, UK, and funded by the British Heart Foundation (BHF), revealed that short-term statin treatment provided no benefits to heart surgery patients and actually increased the risk of developing kidney damage.
The study, published last night (4 May, 2016) in the New England Journal of Medicine, concluded that there is no clinical benefit in having statin therapy for heart surgery, which could lead to a change in guidelines.
However, the authors said that there is still strong evidence that long-term treatment with statins reduces heart attack and stroke risk by lowering the levels of LDL cholesterol.
The trial, led by BHF Professor Barbara Casadei at the University of Oxford, comprised 1,922 people at the Fuwai Hospital, China, all of whom were scheduled for heart surgery.
The cohort was randomly split into two groups, one of which was given 20g of rosuvastatin a day and the other a placebo tablet for up to eight days before surgery and for five days afterwards.
The concentration of the C-reactive protein was lower in the patients who took statins for a just a few days compared with the placebo group.
But the rates of atrial fibrillation following surgery were not significantly different – 21.1% among the statin group and 20.5% among the placebo cohort. The levels of the protein troponin I in the blood were also similar.
However, the patients who took the statins were more at risk of developing acute kidney injury after surgery, with a recorded rate of 24.7% among the statin group and 19.3% among the patients who took the placebo.
Professor Casadei, who is a consultant cardiologist at the John Radcliffe Hospital, Oxford, UK, said: “Statins have been known to have rapid anti-inflammatory and antioxidant effects for many years. It was important to establish whether such effects would translate into patient benefit in conditions accompanied by a strong inflammatory response, such as heart surgery.
“Although guidelines currently recommend statins at the time of heart surgery to reduce complications, the evidence was not very strong. The results of our large randomised placebo-controlled trial conclusively prove that there are no benefits to taking statins shortly before and after heart surgery to reduce postoperative complications but there is an adverse effect on kidney function.
“We expect these results to rapidly change guidelines around the world to ensure patients receive the best evidence-based care.”
Professor Peter Weissberg, medical director at the British Heart Foundation, which helped fund the research, added: “A clinical trial that shows that a drug is ineffective is as important as one that demonstrates benefit. Large, properly conducted clinical trials like this are vital for providing the robust evidence needed to show which treatments are safest and most effective and to inform clinical guidelines.
"This study clearly shows that statins should not be given to patients at the time of heart surgery in an attempt to reduce complications like atrial fibrillation. But the study does not negate the wealth of evidence showing that long-term statin treatment reduces the risk of future heart attacks and strokes.”
Zheng Z., Jayaram R., Jiang L., et al. Perioperative Rosuvastatin in Cardiac Surgery. The New England Journal of Medicine 4 May 2016; 374:1744-53; doi: 10.1056/NEJMoa1507750.
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