SECURE-PCI Studies Benefit of Administering Statins at Time of PCI
March 11, 2018—The SECURE-PCI randomized clinical trial evaluated the effect of administering a loading dose of atorvastatin before planned percutaneous coronary intervention (PCI) on major adverse cardiovascular events in acute coronary syndrome.
The SECURE-PCI findings were presented by Otavio Berwanger, MD, in a Late Breaking Trial session at the American College of Cardiology's (ACC) 67th annual scientific session held March 10–12 in Orlando, Florida. The study was simultaneously published online by Dr. Berwanger et al in Journal of the American Medical Association. Dr. Berwanger is a cardiologist and clinical epidemiologist at the Brazilian Clinical Research Institute in Sao Paulo, Brazil.
In this trial, patients were randomized to receive either a placebo or a loading dose of a statin, consisting of two double doses administered the day before and the day after a scheduled PCI, followed by a daily low dose of a statin for 30 days.
According to the ACC announcement, the trial is the largest study to date aimed at testing the hypothesis that statins could help reduce cardiovascular events around the time of PCI. More than 4,100 patients were enrolled in the trial at 58 centers in Brazil. All patients had acute coronary syndrome for which doctors planned to perform PCI within 7 days. However, approximately one-third of the study participants did not ultimately undergo PCI because doctors opted to perform other treatments, such as coronary artery bypass grafting.
Dr. Berwanger reported that participants in this study were reflective of the broader population of people with acute coronary syndrome, and the study protocols were reflective of common hospital practices. He suggested that the results would likely be applicable in many countries and health care environments.
Approximately 70% of the patients had never taken statins, and approximately 30% had taken them previously or were on low-dose statins when they enrolled in the study. Patients who were already taking a maximum tolerated dose of statins were excluded.
In the double-blinded study, half of the participants were randomly assigned to receive two double (80 mg) doses of atorvastatin—one shortly before the procedure and one within a day after the procedure. The other half received two doses of a placebo. All patients then took 40 mg of atorvastatin daily for 30 days, which is standard practice after acute coronary syndrome.
The trial’s primary endpoint was the 30-day rate of major adverse cardiac events, which included death, heart attack, stroke, or urgent procedures to clear blocked arteries.
Among all patients, the primary endpoint occurred in 6.2% of those taking the statin and 7.1% of those taking the placebo, a difference that was not statistically significant.
Among patients who underwent PCI, the primary endpoint occurred in 6% of those taking the statin and 8.2% of those taking the placebo, a reduction that was statistically significant.
Overall, patients who underwent PCI and received a loading dose of statins were 28% less likely to experience a major adverse cardiac event and 32% less likely to have a heart attack compared with those taking the placebo.
In the ACC announcement, Dr. Berwanger commented, “Although the trial is negative for our primary endpoint in the full study population, the findings of our prespecified analysis are very consistent with smaller trials and observational studies that suggest a reduction in events in the PCI population. Viewed in the context of the literature, our study helps to confirm what has been shown before and suggests that it can be beneficial to consider giving a loading dose of a statin to patients who undergo PCI.”
Dr. Berwanger added, “This study adds another piece to the puzzle. I think it also opens the stage for testing other lipid-lowering agents that may have effects beyond lowering lipids.”
The SECURE-PCI investigators will continue to track outcomes for 12 months and are planning another trial focused on assessing potential benefits of statins and other drugs in patients undergoing PCI, advised the ACC announcement.