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Effect of Loading Dose Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The Secure-Pci Randomized Clinical Trial
Berwanger O, Santucci EV, de Barros e Silva PGM, et al. JAMA. 2018; 319: 1331-40.
Study Question: Does a periprocedural atorvastatin loading dose decrease 30-day major cardiovascular adverse events (MACE) in patients with an acute coronary syndrome (ACS) and planned percutaneous coronary intervention (PCI)?
Study Description: This multicenter, double-blind, randomized controlled trial evaluated adult patients with ACS and a planned PCI in the following seven days. Patients were randomized to the atorvastatin or conventional management group. The atorvastatin group received 80 mg pre- and 24 hours post-PCI while the conventional group received placebo. All patients received atorvastatin 40 mg daily for 30 days thereafter. The primary outcome was MACE [a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and unplanned coronary revascularization] at 30 days. Secondary endpoints were the individual components of the primary outcome, cardiovascular death, stent thrombosis, target vessel revascularization, and periprocedural MI at various time points.
Results: The atorvastatin group included 2087 patients while the control group had 2014 patients. Approximately 73% of patients received a coronary intervention with 65% receiving a PCI. There was no difference in the incidence of MACE at 30 days between the atorvastatin and conventional groups (6% vs. 7%, p=0.27). A lower incidence of MACE occurred in patients randomized to atorvastatin in the PCI subgroup (6% vs. 8%, p=0.02) while there was no difference seen in the non-PCI subgroup. There were no differences between the groups for any of the secondary endpoints.
Conclusion(s): Atorvastatin loading doses did not reduce the incidence of 30-day MACE in patients with ACS and planned PCI.
Perspective: Smaller studies have suggested statin loading doses reduce 30-day MACE; however, the study population in these trials included primarily patients undergoing PCI with stable coronary disease. The SECURE-PCI trial demonstrates no benefit of loading doses of atorvastatin over placebo in reducing 30-day MACE for patients with ACS and scheduled for PCI. Inclusion of non-PCI patients may have contributed to this finding. While current guidelines recommend high-dose statin therapy in patients with ACS, the optimal timing of when to initiate therapy remains unclear. The findings of this study may be useful in patients with ACS undergoing a PCI.