Atorvastatin for Reduction of Myocardial Damage During Angioplasty - ARMYDA-RECAPTURE — Presented at ACC.09/i2

Mar 30, 2009
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Date Presented:
01/01/2009
Date Updated:
03/30/2009
Original Posted Date:
03/30/2009
References

Description:

The goal of the trial was to evaluate treatment with a loading dose of atorvastatin in patients on chronic statin therapy undergoing percutaneous coronary intervention (PCI).

Hypothesis:

An atorvastatin reload (80 mg within 12 hours prior to PCI and further 40 mg preprocedural dose) would reduce the incidence of major adverse cardiac events (MACE) following PCI.

Study Design

Study Design:

Patients Screened: 793
Patients Enrolled: 352
Mean Follow Up: 30 days
Mean Patient Age: 66 years
Female: 20

Patient Populations:

  • Patients with stable angina or non-ST elevation acute coronary syndrome (NSTE ACS) on chronic statin therapy (>30 days) undergoing PCI

Exclusions:

  • STEMI
  • High-risk NSTE ACS requiring urgent angiography within 2 hours
  • Serum alanine aminotransferase or aspartate aminotransferase >ULN
  • Left ventricular ejection fraction <30%
  • Serum creatinine >3 mg/dl
  • History of liver or muscle disease

Primary Endpoints:

  • MACE at 30 days (composite of cardiac death, MI, or unplanned revascularization)

Secondary Endpoints:

  • Postprocedural increase in troponin-I and CK-MB
  • Postprocedural peak CRP

Drug/Procedures Used:

Patients on chronic statin therapy with stable angina or non–ST-elevation myocardial infarction (STEMI) undergoing PCI were randomized to an atorvastatin reload (n = 177) or placebo (n = 175).

Concomitant Medications:

For the atorvastatin reload and placebo groups: statin (100%, 100%), aspirin (99%, 100%), clopidogrel (100%, 100%), beta-blockers (41%, 38%), angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (66%, 73%), and glycoprotein IIb/IIIa inhibitors (12%, 12%), respectively

Principal Findings:

The incidence of MACE was significantly lower in patients treated with atorvastatin reload prior to PCI (3.4% vs. 9.1%, p = 0.04), and this was confirmed in a multivariate analysis (95% confidence interval 0.20-0.82, odds ratio 0.52, p = 0.04). The incidence of creatine kinase-myocardial band (CK-MB) and troponin-I elevation greater than the upper limit of normal (ULN) was also lower in the atorvastatin reload group (13% vs. 23%, p = 0.02 and 36% vs. 47%, p = 0.03, respectively).

The incidence of death, target vessel revascularization, and stent thrombosis was low and not significantly different between groups. Postprocedural C-reactive protein (CRP) rise was somewhat reduced in the atorvastatin reload group, although this did not achieve statistical significance.

Interpretation:

The ARMYDA trial previously demonstrated that atorvastatin loading prior to PCI was effective in reducing postprocedure MI in statin-naïve patients. The results of ARMYDA-RECAPTURE suggest that a loading dose of atorvastatin prior to PCI may reduce postprocedure MACE even in patients on background statin therapy.

These results complement the findings from the NAPLES II trial and provide further evidence of the pleiotropic effects of statin therapy. Taken together, these data suggest that patients undergoing PCI may benefit from pretreatment with a loading dose of atorvastatin, regardless of their background statin history.

References:

Efficacy of Atorvastatin Reload in Patients on Chronic Statin Therapy Undergoing Percutaneous Coronary Intervention. Preliminary Results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage during Angioplasty) Randomized Trial. Presented by Dr. Germano DiSciascio at ACC.09/i2, Orlando, FL, March 2009.

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Multivariate Analysis, Angina, Stable, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Creatine Kinase, MB Form, Coronary Disease, Heptanoic Acids, Hypercholesterolemia, Percutaneous Coronary Intervention, Stents, Pyrroles, Complement System Proteins, C-Reactive Protein, Thrombosis, Troponin I


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