Fatty Acid Antiarrhythmia Trial - FAAT

Description:

The goal of the trial was to evaluate treatment with fish oil compared with placebo on the occurrence of ventricular arrhythmias in high-risk patients with implanted cardioverter defibrillators (ICDs).

Study Design

Study Design:

Patients Enrolled: 402
Mean Follow Up: 1 years
Mean Patient Age: Mean age 65 years
Female: 17

Patient Populations:

ICD implanted in preceding 12 months because of a history of cardiac arrest, sustained ventricular tachycardia (VT), or syncope with inducible, sustained VT or ventricular fibrillation (VF) during electrophysiologic studies.

Primary Endpoints:

Time to first ICD event for ventricular tachycardia or fibrillation (VT or VF) at 12 months

Drug/Procedures Used:

Patients were randomized in a double-blind manner to 12 month treatment with daily fish oil capsule (four 1.0 g per day; n=200) or placebo (olive-oil capsule; n=202). ICD reports and blood samples were collected every 3 months.

Principal Findings:

Mean time from ICD implantation was 1.45 years in the fish oil group and 1.77 years in the placebo group. Baseline ejection fraction was 34%. History of atrial fibrillation was present in 18% of patients. The primary indications for ICD included spontaneous sustained VT (44%), cardiac arrest (36%), and syncope and inducible sustained VT/VF (19%). Study drug was discontinued in 35% of patients, with no difference between groups.

At the final study visit, the concentration of EPA plus DHA as the percentage of total fatty acids was higher in the fish oil group (7.6 vs 3.5, p<0.0001). The primary endpoint of time to first confirmed ICD event for VT/VF trended longer in the fish oil group compared with placebo (event by 12 months, 28% in fish oil vs 39% for placebo, relative risk [RR] 0.72, p=0.057). Occurrence of definite or probable VT/VF occurred less often in the fish oil group (RR 0.69, p=0.033). Among the subgroup of patients compliant for at least 11 months (n=236), definite VT/VF occurred less often in the fish oil group compared with placebo (RR 0.62, p=0.034). There was no difference in mortality between groups (n=13 in fish oil group vs n=12 in placebo group).

Interpretation:

Among patients with an ICD at high-risk for ventricular arrhythmias, treatment with fish oil was associated with a non-significant reduction in the primary endpoint of time to first ICD event for VT/VF through 12 months compared with placebo.

Randomized trials of fish oil for prevention of ventricular arrhythmias have shown mixed results, including a trial by Raitt et al showing a trend toward increases in ventricular tachyarrhythmias associated with fish oil treatment. Additionally, fish oil has shown favorable results in reducing sudden death in the setting of post-myocardial infarction patients. Given these conflicting results, caution should be used until larger definitive trials are available, despite the somewhat positive findings in the present study.

References:

Leaf A, et al. Prevention of Fatal Arrhythmias in High-Risk Subjects by Fish Oil n-3 Fatty Acid Intake. Circulation. 2005;112:2762-2768.

Clinical Topics: Arrhythmias and Clinical EP, Dyslipidemia, Implantable Devices, SCD/Ventricular Arrhythmias, Lipid Metabolism, Nonstatins

Keywords: Risk, Myocardial Infarction, Tachycardia, Ventricular, Fish Oils, Olea, Ventricular Fibrillation, Fatty Acids, Syncope, Death, Sudden, Cardiac, Defibrillators, Implantable


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