A large loading dose of a statin did not reduce the primary outcome of major adverse cardiovascular events (MACE) among patients with acute coronary syndrome (ACS) and planned PCI, according to results of the SECURE-PCI trial. However, MACE events were reduced in the prespecified subset of patients who actually underwent PCI. The trial was presented by Otavio Berwanger, MD, PhD, on Sunday, March 11 in a Late-Breaking Clinical Trial session at ACC.18 in Orlando, FL, and simultaneously published in the Journal of the American Medical Association.

The investigators randomized 4,197 patients with ACS in 58 centers in Brazil scheduled for PCI to receive a loading dose of atorvastatin 80 mg followed by an additional 80 mg atorvastatin or matching placebo within seven days of the planned intervention. Subsequently, both groups of patients received atorvastatin 40 mg for the next 30 days. The primary endpoint was the rate of MACE at 30 days, defined as a composite of all-cause mortality, nonfatal acute myocardial infarction (MI), nonfatal stroke and unplanned coronary revascularization.

The mean age of the patients was 62 years and 25.9 percent were women. At study entry, 24.8 percent of patients had STEMI; 60.7 percent had NSTEMI; and 14.5 percent had unstable angina. Only 64.5 percent of patients underwent PCI within a median 20 hours after hospital admission.

The primary endpoint occurred in 6.2 percent of patients in the overall group receiving the atorvastatin loading dose compared with 7.1 percent of patients receiving placebo. The difference was not statistically significant. Among patients who received PCI, there was a significant difference in the primary endpoint, which occurred in 6 percent of those who received the loading dose versus 8.2 percent of patients who received placebo. The patients will be followed for a total of 12 months.

"This study adds another piece to the puzzle," said Berwanger. "I think it also opens the stage for testing other lipid-lowering agents that may have effects beyond lowering lipids." The investigators are planning another trial focusing on the potential benefits of statins and other drugs in patients undergoing PCI.

Keywords: ACC18, ACC Annual Scientific Session, Angina, Stable, Coronary Artery Disease, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Acute Coronary Syndrome, Double-Blind Method, Angina, Unstable, Percutaneous Coronary Intervention, Myocardial Infarction, Diabetes Mellitus, Stroke, Hypertension

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