Abstract
BackgroundIn recent years, there has been a large amount of studies about the efficacy and safety of vernakalant or RSD1235, an antiarrhythmic agent, in treating the atrial fibrillation (AF). This study was designed to assess the efficacy and safety of vernakalant in the treatment of AF.ResultsA total of 5 randomized controlled trials (RCTs) (n= 1153) met our inclusion criteria. Vernakalant was superior in achieving sinus rhythm (SR) for AF comparing to placebo or alternative anti-arrhythmic agents (relative risk [RR] = 11.56, 95% Confidence Interval [CI] = 7.12 – 18.75). There was no heterogeneity among the trials (X2 =0.59, P = 0.96). In analysing the adverse effects of cardiac origin, there was no significant difference between the two groups (RR= 0.90, 95% CI = 0.52 – 1.57).MethodsThe Cochrane library, Pubmed NCBI, EMBASE and MEDLINE were systematically searched to identify all interventional trials of vernakalant with placebo or other antiarrhythmic drug in converting AF to SR. The primary outcome was rate of converting to SR, and the secondary outcome was the rate of adverse effects of cardiac origin due to vernakalant and the placebo or amiodarone. Meta-analyses were carried out using Mantel-Haenszel fixed-effects or random-effects models and heterogeneity was by the X2 test.ConclusionIn the conversion of AF to SR, vernakalant is highly effective without obviously raised side effects. Owing to only one study comparing vernakalant with amiodarone included in this study, the efficacy of vernakalant comparing to other antiarrhythmic agents needing more well-designed double-blinded RCTs to be confirmed.
Highlights
In recent years, there has been a large amount of studies about the efficacy and safety of vernakalant or RSD1235, an antiarrhythmic agent, in treating the atrial fibrillation (AF)
Statistical analysis The differences in categorical outcomes between vernakalant and placebo or an alternative antiarrhythmic drug were reported as risk ratio (RR) with 95% confidence interval (CI), using a fixed effect model
Adverse effects of cardiac origin All five trials included in this study showed adverse events (AEs) of cardiac origin
Summary
Study selection and description Our electronic searches identified 80 studies of which 5 articles [7,8,11,12,13] fulfilled our inclusion criteria and were subjected to meta-analysis (Figure 1). Data extraction One author performed the literature search, and data extraction was independently conducted by two individuals. The following information was extracted: publication details, timing of study, duration of follow-up, randomization method, blinding (of participants, investigators, and outcome assessors), vernakalant dosage and route of administration, dropouts, mean age of participants, primary outcome (conversion rate to sinus rhythm) and secondary outcome (adverse events of cardiac origin). Any disagreements in the collected data was elucidated by consensus or, if necessary, upon consultation with a third reviewer. The authors of the original publications were contacted to obtain missing data. Data were checked and entered into the Review Manager 5 for Windows. Outcomes of interest The proportion of patients with atrial fibrillation converted to sinus rhythm within different duration of treatment was chosen as the primary outcome because it is the most relevant clinical outcome in patients with AF.
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