Effect of Loading Dose of Atorvastatin Prior to Planned PCI: The SECURE-PCI Randomized Clinical Trial

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

 
Trial References

Patti G, Cannon CP, Murphy SA, et al. Clinical benefit of statin pretreatment in patients undergoing percutaneous coronary intervention: a collaborative patient-level meta-analysis of 13 randomized studies. Circulation. 2011;123(15):1622-1632.

Abstract | Full Text

Nicholls SJ, Psaltis PJ. Lipid Lowering in Acute Coronary Syndrome. Is Treatment Early Enough? JAMA. 2018;319(13):1325-1326.

Abstract | Full Text

 
Expert Comment

Alberto J. Lorenzatti, MD

The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. This is a multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil. In total, 4191 patients were enrolled with ACS evaluated by coronary angiography, and this was followed by a percutaneous coronary intervention (PCI) if indicated, to determine if peri-procedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE), a composite of all-cause mortality, myocardial infarction, stroke and unplanned coronary revascularization.

Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients were subsequently treated with atorvastatin, 40 mg/d, for the remaining 30 days, starting 24 hours after the second dose of study medication. A total of 2710 (64.7%) patients underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had medical treatment without intervention.

The rate of 30-day MACE was 6.2% among patients who received loading doses of atorvastatin and 7.1% among patients who received placebo (hazard ratio: 0.88; 95% CI, 0.69-1.11; P = .27), a non-significant difference. However, among patients who underwent PCI, fewer events were experienced in the group who received the atorvastatin loading doses compared with those receiving placebo (6.0% vs. 8.2%; HR, 0.72; 95% CI, 0.54-0.96; P = .02).

Conclusion

Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management.

In previous small trials, the benefit of loading doses of statins among ACS patients was observed only in patients treated with PCI. This study likewise did not show a reduction in MACE at 30 days in the overall ACS population. However, the significant reduction in MACE among patients undergoing PCI suggests a benefit of loading doses in the periprocedural setting.

Although, this study did not show a reduction in MACE at 30 days in the overall ACS population, the significant reduction in MACE among patients undergoing PCI suggests a benefit of loading doses in the periprocedural setting. This prespecified subgroup analysis of patients who underwent PCI should be viewed only as purely exploratory, however it suggests a role in modifying adverse atherosclerotic events in which the very early use of high-intensity statin therapy may be beneficial in selected high risk patients.

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