Statins Evaluation in Coronary Procedures and Revascularization - SECURE-PCI

Mar 11, 2020
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Brazilian Ministry of Health
Date Presented:
09/24/2018
Date Published:
02/25/2020
Date Updated:
03/11/2020
Original Posted Date:
03/11/2018
References

Contribution To Literature:

The SECURE-PCI trial showed that routine administration of two early doses of high-dose atorvastatin is not superior to placebo in reducing cardiovascular events at 30 days among patients presenting with ACS and scheduled to undergo an early invasive approach.

Description:

The goal of the trial was to compare the safety and efficacy of two loading doses of atorvastatin (80 mg) given early among patients presenting with acute coronary syndrome (ACS) for whom an early invasive approach was planned.

Study Design

Patients presenting with ACS were randomized in a 1:1 fashion to receive either two loading doses of atorvastatin 80 mg before and 24 hours after a planned early invasive approach (n = 2,087) or placebo (n = 2,104). All patients in both groups were to receive 40 mg/d of atorvastatin after the procedure through 30 days.

  • Total number of enrollees: 4,191
  • Duration of follow-up: 30 days
  • Mean patient age: 61.8 years
  • Percentage female: 26%

Inclusion criteria:

  • Age ≥18 years
  • ACS with planned invasive management planned within 7 days

Exclusion criteria:

  • Use of fibrate in 24 hours prior to loading dose
  • Use of any statin at maximum dose in the 24 hours prior to loading dose

Other salient features/characteristics:

  • ST-segment elevation myocardial infarction (STEMI): 25%, NSTEMI: 60%, unstable angina: 15%
  • Previous long-term statin use: 29%
  • Diabetes: 32%
  • Initial treatment strategy: percutaneous coronary intervention (PCI) 65%, coronary artery bypass grafting (CABG) 8%, medical management 27%

Principal Findings:

The primary outcome, major adverse cardiac events (MACE), for statin vs. placebo, was 6.2% vs. 7.1%, p = 0.27.

  • Death: 3.2% vs. 3.3%, p = 0.84
  • MI: 2.9% vs. 3.7%, p = 0.18

Secondary outcomes (for statin vs. placebo):

  • Stroke: 0.5% vs. 0.5%, p = 0.85
  • Stent thrombosis: 0.3% vs. 0.7%, p = 0.10
  • Low-density lipoprotein cholesterol (LDL-C): 79.6 vs. 75.8 mg/dl

Among patients undergoing PCI (p = 0.02 for interaction):

  • MACE: 6.0% vs. 8.2%, p = 0.02
  • MI: 3.6% vs. 5.2%, p = 0.04

These results were similar irrespective of timing of administration of atorvastatin prior to PCI, including for STEMI patients (p for interaction = 0.44).

12-month outcomes (for statin vs. placebo):

  • Use of statins at 12 months: 87% in both arms
  • MACE rates: 11.3% vs. 12.1%, hazard ratio 0.94, 95% confidence interval 0.76-1.14
  • MI: 4.5% vs. 4.8%, p > 0.05
  • Stent thrombosis: 0.7% vs. 1%, p > 0.05

These results were similar among patients who had undergone PCI vs. those who did not (p for interaction = 0.21).

Interpretation:

The results of this trial indicate that routine administration of two early doses of high-dose atorvastatin is not superior to placebo in reducing cardiovascular events at 30 days among patients presenting with ACS and scheduled to undergo an early invasive approach. Among patients who underwent PCI, there were significant reductions in MACE and non–PCI-related MI. This benefit was maintained irrespective of timing of administration of statin prior to PCI.

Considering that LDL-C levels were similar in both arms (both arms received 40 mg of atorvastatin daily after the initial load), and the benefit in the PCI patients occurred early, the mechanism for benefit in these patients is likely due to the pleiotropic effects of statins. The study also highlights how heterogeneous an ACS population can be, both from a risk and a clinical response perspective.

References:

Lopes RD, de Barros e Silva PG, Damiani LP, et al. Major Adverse Cardiovascular Events After 12 Months Among Patients With Acute Coronary Syndrome Receiving Loading Doses of Atorvastatin Prior to Planned PCI. JAMA 2020;323:787-9.

Lopes RD, de Barros e Silva PG, de Andrade Jesuíno I, et al. Timing of Loading Dose of Atorvastatin in Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes: Insights From the SECURE-PCI Randomized Clinical Trial. JAMA Cardiol 2018;3:1113-8.

Berwanger O, Santucci EV, de Barros e Silva PG, et al., on behalf of 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;319:1331-40.

Editorial: Nicholls SJ, Psaltis PJ. Lipid Lowering in Acute Coronary Syndrome: Is Treatment Early Enough? JAMA 2018;319:1325-6.

Presented by Dr. Otavio Berwanger at the American College of Cardiology Annual Scientific Session (ACC 2018), Orlando, FL, March 11, 2018.

Keywords: ACC18, ACC Annual Scientific Session, Acute Coronary Syndrome, Angina, Unstable, Cholesterol, LDL, Dyslipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Stents, Stroke, Thrombosis, TCT18, Transcatheter Cardiovascular Therapeutics


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