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Loire-Ardèche-Drôme-Isère-Puy-de-Dôme - LADIP
Description:
The goal of the trial was to evaluate treatment with amiodarone therapy compared with radiofrequency catheter ablation (RFA) among patients with a first episode of symptomatic atrial flutter (AFL).
Study Design
Study Design:
Patients Enrolled: 104
Mean Follow Up: Mean 13 months
Mean Patient Age: Mean age 78 years
Female: 19
Patient Populations:
Age ≥70 years, first documented episode of symptomatic AFL without previous antiarrhythmic treatment, ECG documenting typical AFL, and isthmus participation in the arrhythmic circuit as demonstrated by entrainment maneuvers
Exclusions:
Amiodarone contraindication, previous antiarrhythmic treatment for AFL, AFL recurrence, inability to catheterize (vena caval clip), poorly tolerated AFL including 1/1 AFL, contraindication of anticoagulation therapy, New York Heart Association class IV heart failure, current or previous treatment with amiodarone, a corrected QT interval of >480 ms or an uncorrected QT interval of >500 ms in the absence of bundle branch block, bradycardia, or any condition that would make survival for 1 year unlikely
Primary Endpoints:
Time to recurrence of AFL confirmed by ECG
Secondary Endpoints:
Time to first occurrence of AF confirmed by ECG
Drug/Procedures Used:
Following a first episode of AFL, patients were randomized to first-line RFA (n = 52) or cardioversion and amiodarone therapy (n = 51). Amiodarone was given as a loading dose (400 mg/day for 4 weeks and at least 7 days before sinus rhythm restoration), followed by 200 mg/day.
Among patients age <75 years without underlying cardiac disease or stroke risk factors, oral anticoagulant could be changed to aspirin if sinus rhythm was present at 1 month. Other patients continued to receive oral anticoagulant therapy. Patients underwent Holter monitoring for 7 days.
Principal Findings:
Structural heart disease was present in 61% of patients, hypertension in 68%, and history of prior AF in 24%. Mean baseline left atrial systolic diameter was 43 mm and left ventricular ejection fraction was 55%. In the RFA group, there were no procedural complications; mean RF application time was 12.8 minutes and mean fluoroscopic time was 12 minutes. In the amiodarone group, conversion to sinus rhythm occurred in all patients.
The primary endpoint of AFL recurrence occurred more frequently in the amiodarone group compared with the RFA group (29.5% vs. 3.8%, p < 0.0001). All patients in the amiodarone group who had recurrent AFL were subsequently treated with RFA. There was no difference in atrial fibrillation between the groups (18% for the amiodarone group vs. 25% for the RFA group, p = 0.3). Mortality did not differ between groups (16% in the amiodarone group vs. 11% in the RFA group, p = 0.7).
Interpretation:
Among patients with a first episode of symptomatic AFL, treatment with RFA was associated with a reduction in recurrence of AFL at a mean 13-month follow-up compared with cardioversion and amiodarone therapy.
While AFL was reduced with RFA, there was no difference in the frequency of atrial fibrillation with RFA compared to amiodarone therapy in this study, despite occurring in ~20% of patients. The economic implications of first-line therapy with RFA for initial AFL is unknown.
References:
Da Costa A, Thévenin J, Roche F, et al. Results from the Loire-Ardèche-Drôme-Isère-Puy-de-Dôme (LADIP) trial on atrial flutter, a multicentric prospective randomized study comparing amiodarone and radiofrequency ablation after the first episode of symptomatic atrial flutter. Circulation 2006;114:1676-81.
Keywords: Follow-Up Studies, Electric Countershock, Risk Factors, Stroke Volume, Electrocardiography, Ambulatory, Catheter Ablation, Hypertension, Atrial Flutter
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