CIRCUS Trial Results: Cyclosporine No Better than Placebo for Heart Failure Following PCI
AUGUST 29, 2015
MD Magazine Staff
According to trial results presented by Michel Ovize, MD, PhD, Louis Pradel Hospital and Claude Bernard University, Lyon, France, at ESC Congress 2015, treatment with cyclosporine was no better than placebo for patients who received percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).
Results from the CIRCUS (Does Cyclosporine Improve Clinical Outcome in ST Elevation Myocardial Infarction Patients) trial showed that treatment with cyclosporine 2.5 mg per kilogram prior to PCI “had no impact on a composite of all-cause death, hospitalization for - or worsening of - heart failure, or adverse left ventricular remodeling at one year,” according to information provided by ESC.
For the trial, investigators enrolled patients “who presented within 12 hours after the onset of symptoms that were consistent with an acute coronary syndrome, who had ST-segment elevation of 0.2 mV or more in two contiguous anterior leads, and for whom the clinical decision was made to treat with PCI,” according to results published in the New England Journal of Medicine. Patients also had a TIMI score of 0 or 1.
In the trial, “a primary outcome event occurred in 233 of 395 patients (59.0%) in the cyclosporine group and in 230 of 396 (58.1%) in the control group (odds ratio in the cyclosporine group, 1.04; 95% confidence interval [CI], 0.78 to 1.39; P=0.77).”
The investigators also reported that all-cause mortality at 1 year was 7.1% in the cyclosporine group vs. 6.6% in the control group (odds ratio, 1.09; 95% CI, 0.63 to 1.90; P=0.76).
Heart failure worsening or rehospitalization due to heart failure at 1 year was 22.8% in the cyclosporine group vs. 22.7% in the control group (odds ratio, 1.01; 95% CI, 0.72 to 1.41; P=0.97).
Adverse left ventricular remodeling occurred in 42.8% of patients in the cyclosporine group vs. 40.7% of patients in the control group (odds ratio, 1.09; 95% CI, 0.82 to 1.46; P=0.53).
The study authors also reported that “rates of all other secondary clinical outcomes, including cardiogenic shock, recurrent myocardial infarction, unstable angina, stroke, and acute renal failure, were similar in the two groups at 1 year.”