Efficacy of High-Dose Atorvastatin Loading Before Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction - STATIN STEMI

Mar 15, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Korea Health 21 R&D ProjectKorea Healthcare Technology R&D ProjectThe Ministry of Health and Welfare and Republic of KoreaMinister for Health, Welfare, and Family Affairs, Republic of KoreaCardiovascular Research Center, Seoul, Korea
Date Published:
01/01/2010
Date Updated:
03/15/2010
Original Posted Date:
03/15/2010
References

Description:

The goal of the trial was to evaluate treatment with high-dose atorvastatin compared with low-dose atorvastatin prior to primary percutaneous coronary intervention (PCI) among patients with ST-elevation myocardial infarction (STEMI).

Hypothesis:

High-dose atorvastatin would be more effective at preventing major adverse cardiac events.

Study Design

  • Parallel

Patients Screened: 408
Patients Enrolled: 171
Mean Follow Up: 9 months
Mean Patient Age: 60 years
Female: 23%
Mean Ejection Fraction: 47%

Patient Populations:

  • Patients at least 18 years of age with STEMI

Exclusions:

  • Age >80 years
  • Current statin treatment
  • Known allergy to heparin, aspirin, clopidogrel, or abciximab
  • Active bleeding
  • Pregnancy
  • History of major surgery or trauma
  • History of cerebrovascular accident
  • Cardiogenic shock with mechanical ventilation

Primary Endpoints:

  • Death, nonfatal MI, or target vessel revascularization at 30 days

Secondary Endpoints:

  • Corrected TIMI frame count
  • Myocardial blush grade
  • ST-segment resolution

Drug/Procedures Used:

Patients with STEMI in Korea were randomized to atorvastatin 80 mg (n = 86) versus atorvastatin 10 mg (n = 85) before PCI. Both groups received atorvastatin 10 mg after PCI.

Concomitant Medications:

Both groups received clopidogrel 600 mg prior to PCI.

In the high-dose atorvastatin arm, the in-hospital use of a glycoprotein IIb/IIIa inhibitor was 24%, aspirin 100%, clopidogrel 100%, beta-blocker 80%, and angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker 92%.

Principal Findings:

Overall, 171 patients were randomized. The mean age was 60 years, 23% were women, 22% were diabetics, and mean left ventricular ejection fraction was 47%. The mean door-to-balloon time was 76 minutes in the atorvastatin 80 mg group and 77 minutes in the atorvastatin 10 mg group.

The primary composite outcome of death, MI, or urgent target vessel revascularization at 30 days occurred in 5.8% of the atorvastatin 80 mg group versus 10.6% of the atorvastatin 10 mg group (p = 0.26). At 9 months, there was still no difference in major adverse cardiac events between the groups (p = 0.32).

Death was 1.2% versus 3.5%, nonfatal MI was 4.7% versus 7.1%, periprocedural MI was 3.5% versus 5.9%, target vessel revascularization was 0% versus 1.2%, and stent thrombosis was 0% versus 1.2% (p = NS, for all comparisons), respectively for high-dose versus low-dose atorvastatin.

Corrected Thrombolysis In Myocardial Infarction (TIMI) frame count was 26.9 versus 34.1 (p = 0.01), myocardial blush grade was 2.2 versus 1.9 (p = 0.02), and complete ST resolution was 39.5% versus 23.8% (p = 0.03), respectively.

Interpretation:

Among patients with STEMI, atorvastatin 80 mg before primary PCI was unable to reduce major adverse cardiac outcomes compared with atorvastatin 10 mg. However, angiographic outcomes (corrected TIMI frame count, myocardial blush grade, and ST resolution) were improved with high-dose atorvastatin.

Although the primary outcome was not significantly reduced with preprocedural atorvastatin 80 mg, each of the individual clinical components was numerically lower from this approach. This trial of 171 patients was likely limited in power to detect a difference in this outcome. Although this is the first trial to test the concept of high-dose statin therapy prior to primary PCI, other trials have demonstrated the benefit of preprocedural statin therapy in elective (ARMYDA) and acute coronary syndrome patients (ARMYDA-ACS). Due to the good safety profile of statin medications and accumulating data of their benefit, their routine use prior to PCI appears reasonable.

References:

Kim JS, Kim J, Choi D, et al., on behalf of the STATIN STEMI Investigators. Efficacy of High-Dose Atorvastatin Loading Before Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction: The STATIN STEMI Trial. JACC Cardiovasc Interv 2010;3:332-9.

Keywords: Pyrroles, Myocardial Infarction, Acute Coronary Syndrome, Republic of Korea, Thrombosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Stroke Volume, Heptanoic Acids, Diabetes Mellitus, Stents, Percutaneous Coronary Intervention


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