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
An erratum to this article was published (JAMA, 4 Sep 2018 ↗)
Authors' 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.
Study context
- Population
- Patients with acute coronary syndrome (ACS) evaluated with coronary angiography to proceed with percutaneous coronary intervention (PCI) if anatomically feasible; all received atorvastatin 40 mg for 30 days after study medication4,163 (99.3%) completed 30-day follow-up
- Participants
- 4,191 patients
- Comparison
- Periprocedural loading doses of atorvastatin vs placebo
- Atorvastatinn = 2,087
- Placebon = 2,104reference
- Primary endpoint
- Major adverse cardiovascular events (MACE):
- All-cause mortality
- MI
- Stroke
- Unplanned coronary revascularization
- Follow-up
- 30 days
Methodological detailsmulticentre, double-blind, placebo-controlled, 53 sites in Brazil, 2710 (64.7%) underwent PCI, 333 (8%) CABG, 1144 (27.3%) exclusively medical management
- Multicentre
- Double-blind
- Placebo-controlled
- 53 sites in Brazil
- 2710 (64.7%) underwent PCI, 333 (8%) CABG, 1144 (27.3%) exclusively medical management
Primary result
As reported in the abstract
Absolute difference (95% CI)
Placebovs Atorvastatin
0.85%(−0.70% to 2.41%)
Hazard ratio (95% CI)P value
Atorvastatinvs Placebo
0.88(0.69–1.11)
P = 0.27Safety
| Outcome | Atorvastatin | Placebo |
|---|---|---|
| Rhabdomyolysis | 0 events | 0.1% |
Hepatic failure
- No cases of hepatic failure reported
Original publication
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. Published 3 April 2018. doi:10.
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