Cholesterol Lowering and Arrhythmias Recurrences After Internal Defibrillator Implantation - CLARIDI

Description:

The goal of the trial was to evaluate the effect of lipid-lowering therapy with atorvastatin compared with placebo among patients with coronary artery disease and internal cardioverter defibrillator (ICD) implants.

Study Design

Patients Screened: 155
Patients Enrolled: 106
Mean Follow Up: 12 months
Mean Patient Age: Mean age 67 years
Female: 6
Mean Ejection Fraction: Mean ejection fraction 40%

Patient Populations:

Coronary artery disease, life-threatening ventricular arrhythmias requiring ICD implantation, total cholesterol <250 mg/dl and not on statin therapy

Exclusions:

Ventricular arrhythmia in the acute phase of MI (within 48 hours)

Primary Endpoints:

First recurrence of an appropriate ICD therapy for VT or VF

Secondary Endpoints:

Composite of death, MI, coronary revascularization, or stroke; number of episodes of electrical storm; number of appropriate ICD therapies

Drug/Procedures Used:

Patients with coronary artery disease and an ICD were randomized in a double-blind manner to atorvastatin 80 mg (n = 53) or placebo (n = 53).

Principal Findings:

ICDs were implanted within the month prior to enrollment in 69% of patients, and 65% received the ICD for sustained ventricular tachycardia (VT). Prior myocardial infarction (MI) was present in 87% of patients and congestive heart failure in 40%.

Low-density lipoprotein cholesterol was reduced in the atorvastatin group from 130 mg/dl at baseline to 65 mg/dl at follow-up, with no significant change in the placebo group. The primary endpoint of ICD therapy occurred less frequently in the atorvastatin group compared with placebo (21% vs. 38%; hazard ratio [HR], 0.47; p = 0.040). There was no difference in the secondary composite endpoint of death, myocardial infarction (MI), revascularization, or stroke (9% for atorvastatin vs. 6% for placebo, p = 0.72). Treatment-related adverse events occurred in 11% of the atorvastatin group and 4% of the placebo group (p = 0.27), the majority of which were gastrointestinal (9% vs. 4%).

Interpretation:

Among patients with coronary artery disease and an ICD implant, treatment with atorvastatin was associated with a reduction in the need for ICD therapies for VT or ventricular fibrillation (VF) by 1 year compared with placebo.

While statin therapy has been shown to be effective in reducing clinical events following an acute coronary syndrome, the effect of statin therapy on ventricular arrhythmias has not previously been demonstrated in a randomized manner. The present trial suggests an arrhythmic benefit of intensive lipid-lowering therapy in an ICD population.

References:

Presented by Johan De Sutter, MD, at the Heart Rhythm Society Annual Scientific Sessions, Boston, MA, May 2006.

De Sutter J, Tavernier R, De Bacquer D, et al. Coronary risk factors and inflammation in patients with coronary artery disease and internal cardioverter defibrillator implants. Int J Cardiol. 2006 Sep 10;112(1):72-9.

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Dyslipidemia, Heart Failure and Cardiomyopathies, Atherosclerotic Disease (CAD/PAD), Implantable Devices, SCD/Ventricular Arrhythmias, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Acute Heart Failure

Keywords: Pyrroles, Cholesterol, Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome, Stroke, Defibrillators, Tachycardia, Ventricular, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Ventricular Fibrillation, Heart Failure, Heptanoic Acids


< Back to Listings