Administering 2 loading doses of 80 mg atorvastatin before and immediately following a planned percutaneous coronary intervention (PCI) does not reduce the rate of major adverse cardiovascular events (MACE) in patients with acute coronary syndrome (ACS), according to findings from the SECURE-PCI clinical trial (Statins Evaluation in Coronary Procedures and Revascularization Trial; ClinicalTrials.gov Identifier: NCT01448642) published in the Journal of the American Medical Association.
A total of 4191 patients with ACS who were to undergo a planned PCI were included in this analysis. Investigators randomly assigned patients to receive either 2 loading doses of 80 mg atorvastatin (n=2087) or matched placebo (n=2104) before and 24 hours following PCI. In both arms, investigators administered 40 mg atorvastatin for a total of 30 days 24 hours after the second loading dose of the study drug or placebo.
MACE, which was defined as a composite of all-cause mortality, stroke, myocardial infarction (MI), and unplanned coronary revascularization through 30 days, comprised the primary outcome.
The majority of participants (64.7%) underwent PCI, whereas 27.3% received medical management, and 8% underwent coronary artery bypass graft procedure. At 30-day follow-up, there was no significant difference between the atorvastatin and placebo arms in terms of MACE rates (6.2% vs 7.1%, respectively; absolute difference, 0.85% [95% CI, –0.70% to 2.41%]; hazard ratio [HR], 0.88; 95% CI, 0.69-1.11; P =.27). In an exploratory analysis of patients who underwent PCI (64.7%), 30-day MACE was significantly lower in the atorvastatin vs placebo groups (6.0% vs 8.2%, respectively; HR, 0.72; 95% CI, 0.54-0.96; P =.02), but there was no difference between the two groups in patients not undergoing PCI procedure (6.7% vs 5.0%; HR, 1.36; 95% CI, 0.89-2.09; P =.15).
There were no differences between the atorvastatin and placebo arms in terms of MI (2.9% vs 3.7%, respectively; HR, 0.80; 95% CI, 0.57-1.11; P =.18), stroke (0.5% vs 0.5%, respectively; HR, 0.92; 95% CI, 0.39-2.16; P =.85), or mortality (3.2% vs 3.3%, respectively; HR, 0.97; 95% CI, 0.69-1.35; P =.84). A total of 3 rhabdomyolysis were reported in the placebo group vs 0 cases in the atorvastatin arm.
The high level of heterogeneity in this patient population represents a potential limitation of this analysis.
Findings from this investigation “do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management” and “may guide medical decision making in these critical scenarios,” the researchers concluded.
Berwanger O, Santucci EV, de Barros E Silva PGM, et al; for the SECURE-PCI Investigators. Effect of loading dose of atorvastatin prior to planned percutaneous coronary intervention on major adverse cardiovascular events in acute coronary syndrome: the SECURE-PCI randomized clinical trial. JAMA. 2018;319(13):1331-1340.