March 11, 2018 – Favorable results were seen in subgroup that underwent PCI.
Atorvastatin is a widely prescribed drug that lowers cholesterol blood levels. But until recently, it was unclear whether a loading dose of atorvastatin could prevent periprocedural myocardial infarction (MI) and other adverse endpoints in patients with acute coronary syndrome (ACS) and planned invasive management.
The Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) study was designed to answer this question. The DCRI’s Renato D. Lopes, MD, MHS, PhD, study co-chair, was senior author of the study, published simulataneously in the Journal of American Medical Association. Co-chair Otavio Berwanger, MD, PhD, of the Hospital de Coração (HCor) in Brazil, presented the study results at the American College of Cardiology meeting in Orlando, Florida today.
SECURE-PCI was a randomized, double-blind, multicenter trial in which patients with ACS were randomized to loading doses of 80mg of atorvastatin or matching placebo before and 24 hours after planned percutaneous coronary intervention (PCI).
The Brazilian Clinical Research Institute (BCRI) coordinated the five-and-a-half-year trial with HCor. SECURE-PCI was conducted at 60 sites throughout Brazil under a grant from the Brazilian Ministry of Health. The DCRI’s Christopher Granger, MD, and John Alexander, MD, MHS, were part of the trial’s steering committee and co-authors on the manuscript.
The study enrolled 4,197 patients with ACS (with or without ST elevation.) The mean age was 61.8 years, and nearly 26 percent of the patients were women. Follow-up for the primary end point was 30 days.
“At 30 days, there were really no differences between the loading dose and placebo,” said Lopes. “But, very interestingly, we did find a 28 percent reduction in the primary endpoint over placebo in the pre-specified subgroup of PCI patients during that time. These findings were primarily driven by the subgroup of patients with ST elevation myocardial infarction, or STEMI.”
The study also showed a 32 percent reduction in myocardial infarction, according to Lopes. “With loading doses in patients undergoing PCI seeming to show improved outcomes, this can be an attractive and reasonable strategy for physicians, especially when treating patients with STEMI and in hospitals that do not use this statin regimen in the first 24 to 48 hours of an ACS event. Of course, caution should be taken when interpreting these results since they derived from a post-randomization subgroup.”
The timing of the study medication varied according to the type of ACS – for those without ST elevation (NSTEMI), the pre-PCI dose was administered between 2 and 12 hours before the procedure. For those with ST elevation myocardial infarction (STEMI), the loading dose was administered as soon as possible before the primary PCI. In both cases, the second dose of 80mg atorvastatin or placebo was administered 24 hours after the procedure.
Of the study population, 4,191 completed the 30-day follow-up and 2,710 patients underwent PCI. The primary endpoint was a composite of all-cause mortality, MI, stroke, and unplanned coronary revascularization through those 30 days.
Major adverse cardiac event (MACE) occurred in 130 patients in the atorvastatin group and 149 of those receiving a placebo. Of the patients who underwent PCI, MACE at 30 days occurred in 81 of 1,351 patients receiving atorvastatin compared with 112 of 1,359 in the placebo group.
“The bottom line is that loading doses of atorvastatin do no harm and can potentially provide benefit for patients undergoing PCI,” said Lopes. “This drug is well known in cardiology, and the SECURE-PCI results can provide insights to help physicians with decisions on whether to start statins in the very early phase of ACS, particularly in patients with STEMI that are undergoing an invasive strategy.”