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ECTOPIC trial: The efficacy of flEcainide Compared To metOprolol in reducing Premature ventrIcular Contractions: A
Robin A Bertels1, Janneke A E Kammeraad2, Nan van Geloven3
1Willem-Alexander Children's Hospital, Leiden University Medical Center, Leiden, The Netherlands.
Insights
Flecainide significantly reduced premature ventricular contractions (PVCs) in children more than metoprolol. Flecainide was effective in a subgroup, independent of plasma levels, for treating frequent PVCs.
Area of Science:
- Pediatric Cardiology
- Electrophysiology
- Pharmacology
Background:
- Frequent premature ventricular contractions (PVCs) in children are often benign.
- Treatment with antiarrhythmic drugs is indicated for symptomatic PVCs or left ventricular dysfunction.
Purpose of the Study:
- To compare the efficacy of flecainide versus metoprolol in reducing PVC burden in pediatric patients.
- To evaluate flecainide and metoprolol as treatments for frequent PVCs in children.
Main Methods:
- A randomized, open-label, crossover trial involving children with >15% PVC burden.
- Patients received sequential treatment with metoprolol and flecainide (or vice versa) with a 2-week drug-free interval.
- Holter monitoring assessed PVC burden before and after each treatment.
Main Results:
- Flecainide demonstrated a significantly greater mean reduction in PVC burden (10.6 percentage points) compared to metoprolol (2.4 percentage points).
- A significant difference in PVC burden reduction was observed between flecainide and metoprolol (P = .031).
- Flecainide responders (9/18) were more frequent than metoprolol responders (1/17), with no clear discriminating factors like plasma levels.
Conclusions:
- Flecainide is more effective than metoprolol in reducing PVC burden in children with frequent PVCs.
- Flecainide efficacy appears limited to a subgroup of patients, not correlated with plasma concentration.
Background:
Frequent premature ventricular contractions (PVCs) in children are usually considered benign. Symptoms and left ventricular dysfunction are indications for treatment with antiarrhythmic drugs.
Objective:
This study aimed to evaluate the efficacy of flecainide vs metoprolol in reducing PVCs in children.
Methods:
A randomized open-label crossover trial was conducted of children with a PVC burden of >15% on Holter monitoring successively treated with metoprolol and flecainide, or vice versa, with a drug-free interval of at least 2 weeks. Holter measurements were repeated before and after the start of the antiarrhythmic drug.
Results:
Sixty patients were screened; 19 patients could be included. Median age was 13.9 years (interquartile range, 5.5 years). Mean baseline PVC burden was 21.7% (n = 18; SD ± 14.0) before the start of flecainide and 21.2% (n = 17; SD ± 11.5) before the start of metoprolol. In a mixed model analysis, the estimated mean reduction in PVC burden was 10.6 percentage points (95% CI, 5.8-15.3) for flecainide and 2.4 percentage points (95% CI,2.7-7.5) for metoprolol, with a significant difference of 8.2 percentage points (95% CI, 0.86-15.46; P = .031). Exploratory analysis revealed that 9 of 18 patients treated with flecainide and 1 of 17 patients treated with metoprolol had a reduction to a PVC burden below 5%. No discriminating factors between flecainide responders and nonresponders were found; the mean plasma level was not significantly different (0.34 mg/L vs 0.52 mg/L; P = .277).
Conclusion:
In children with frequent PVCs, flecainide led to a significantly greater reduction of PVC burden compared with metoprolol. Flecainide was effective in only a subgroup of patients, which appears to be unrelated to the plasma level.
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