Atorvastatin for Reduction of Myocardial Damage During Angioplasty - ARMYDA

Description:

The goal of the study was to evaluate the effect of pretreatment with atorvastatin compared with placebo in patients scheduled for elective percutaneous coronary intervention (PCI) on the risk of procedural myocardial injury.

Hypothesis:

Pretreatment with atorvastatin will be associated with less procedural myocardial injury compared with placebo in patients undergoing elective PCI.

Study Design

Study Design:

Patients Screened: 912
Patients Enrolled: 153
Mean Follow Up: One month
Mean Patient Age: Mean age 64 years
Female: 30
Mean Ejection Fraction: Mean ejection fraction at baseline 54% in each arm

Patient Populations:

Presence of typical stable effort angina, positive stress test, and indication for coronary angioplasty

Exclusions:

Acute MI within three months; unstable angina; any increase in CK-MB, troponin I, or myoglobin above ULN at the time of randomization; any increase in liver enzymes (AST/ALT); left ventricular ejection fraction <30%; renal failure with creatinine >3 mg/dl; history of liver or muscle disease; and current or previous treatment with statins

Primary Endpoints:

Occurrence of MI, defined as a post-procedural increase of CK-MB >2 times above ULN

Secondary Endpoints:

Any post-procedural increase of markers of myocardial injury (CK-MB, troponin I, and myoglobin) ULN; mean peak values of CK-MB, troponin I, and myoglobin after intervention; and occurrence of major adverse cardiac events (death, MI, or need for unplanned revascularization) at one-month follow-up

Drug/Procedures Used:

Patients scheduled for elective PCI were randomized to atorvastatin (40 mg/day, n=76) or placebo (n=77) seven days prior to the procedure. Serial blood draws were taken at baseline and at eight and 24 hours after the procedure to measure creatine kinase-MB (CK-MB), troponin I, and myoglobin levels. Postprocedure, patients in both arms were treated with atorvastatin (40 mg/day).

Concomitant Medications:

Aspirin (100 mg/day); ticlopidine 250 mg twice per day for at least three days before the procedure or clopidogrel 300 mg at least six hours before the procedure. Ticlopidine (250 mg twice per day) or clopidogrel (75 mg/day) was continued for one month, unless treated with drug-eluting stents, in which case treatment was continued for six months.

Principal Findings:

Baseline and procedural characteristics were similar in both groups, with multivessel disease present in 20% of patients and stents used in 92% of the atorvastatin arm and 95% in the placebo arm. There was no difference in the use of drug-eluting stents (13% for atorvastatin vs. 22% for placebo, p=0.19) or use of glycoprotein IIb/IIIa inhibitors (24% vs. 16%, p=0.24).

The primary endpoint of presence post-procedure of myocardial infarction (MI) defined as CK-MB >2x upper limit of normal (ULN) was lower in the atorvastatin group (5% vs. 18%, p=0.025). The presence of markers greater than the ULN was significantly lower in the atorvastatin arm compared with the placebo arm: CK-MB 12% versus 35%, p=0.001; troponin I 20% versus 48%, p=0.0004; myoglobin 22% vs. 51%, p=0.0005. Peak post-procedural levels of each of the markers were also significantly lower in the atorvastatin group compared with the placebo group: CK-MB 2.9 versus 7.5 ng/ml, p=0.007, troponin I 0.09 versus 0.47 ng/ml, p=0.0008, and myoglobin 58 versus 81 ng/ml, p=0.0002.

There were no additional cardiac events in either group at one-month follow-up.

Interpretation:

Among patients undergoing elective PCI irrespective of baseline lipid levels, pretreatment with atorvastatin was associated with a reduction in markers of myocardial injury post-procedure. The LIPS trial showed a reduction in long-term cardiac events associated with statin use in patients undergoing PCI; however, statin therapy was initiated post-procedure and the effect on early myocardial injury was not evaluated. The present trial enrolled low-risk patients and as such was not able to evaluate any effect on clinical outcomes beyond the periprocedural time frame. While the mechanism of action for the reduction of myocardial injury in the atorvastatin arm is not clear, the authors suggest the anti-inflammatory effect of statins may contribute to the reduction.

References:

Pasceri V, Patti G, Nusca A, et al. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention. Results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation 2004;110:674-8.

Clinical Topics: Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Lipid Metabolism, Nonstatins, Novel Agents, Statins

Keywords: Pyrroles, Myocardial Infarction, Drug-Eluting Stents, Troponin I, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Myoglobin, Creatine Kinase, MB Form, Coronary Disease, Heptanoic Acids, Angioplasty, Balloon, Coronary, Thiamine, Exercise Test


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