The STICS trial was funded primarily by the British Heart Foundation, the Oxford Biomedical Research Center, and the UK Medical Research Council. In addition, Dr. Casadei reported receiving an unrestricted grant from AstraZeneca in conjunction with the trial.
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Dr. Hiren Shah |
There are two key lessons from the results of the STICS trial. First, extrapolation of results from biochemical pathways and measured cellular markers does not always translate into meaningful clinical outcomes. Thus, it has long been known from several large trials that statin therapy effectively and rapidly lowers CRP levels both in hyper- and normocholesterolemic patients and that statins are effective in decreasing systemic inflammation. It has also been known that inflammation contributes to the development and maintenance of AF, so it was postulated that by improving endothelial nitric oxide availability, reducing inflammation, and decreasing oxidative stress, and through neurohormonal activation, statins would reduce the incidence of post-op AF. This link was so strong that clinical guidelines adopted limited data from small trials to make treatment recommendations.
This leads us to consider the second key lesson from this study. Trials with small sample size, even when combined across many other trials (1,300 patients were involved across 14 trials in this case), do not always yield reliable results, especially when they have significant limitations, notably not always being blind and having been performed in statin-naive patients only. The large, randomized, and well-designed STICS trial puts to rest an important issue, given the high prevalence of AF after cardiac surgery, which is associated with a longer length of stay, an increased risk of stroke, higher mortality, and greater costs, and should prompt us to consider further evaluation of different strategies to reduce this significant complication.
Dr. Hiren Shah is medical director of the medicine and cardiac telemetry hospitalist unit at Northwestern Memorial Hospital in Chicago and an adviser to Hospitalist News. He is the national chair of the Clinician Committee for ACP’s Initiative on Stroke Prevention and Atrial Fibrillation and is the lead physician for the Society of Hospital Medicine’s National Atrial Fibrillation Initiative.
AT THE ESC CONGRESS 2014