Population Health Research Institute, McMaster University, 237 Barton Street East Hamilton, Ontario, Canada.
Department of Medicine, Queen's University, 76 Stuart St, Kingston, Ontario, Canada.
Europace. 2019 Aug 1;21(8):1159-1166. doi: 10.1093/europace/euz175.
To evaluate the efficacy and safety of vernakalant for the cardioversion of atrial fibrillation (AF).
We reviewed the literature for randomized trials that compared vernakalant to another drug or placebo in patients with AF of onset ≤7 days. We used a random-effects model to combine quantitative data and rated the quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation). From 441 total citations in MEDLINE, EMBASE, and CENTRAL (December 2018), we identified nine trials evaluating 1358 participants. Six trials compared vernakalant to placebo, two trials compared vernakalant to ibutilide, and one trial compared vernakalant to amiodarone. We found significant methodological bias in four trials. For conversion within 90 min, vernakalant was superior to placebo [50% conversion, risk ratio (RR) 5.15; 95% confidence interval (CI); 2.24-11.84, I2 = 91%], whereas we found no significant difference in conversion when vernakalant was compared with an active drug (56% vs. 24% conversion, RR 2.40; 95% CI 0.76-7.58, I2 = 94). Sinus rhythm was maintained at 24 h in 85% (95% CI 80-88%) of patients who converted acutely with vernakalant. Overall, we judged the quality of evidence for efficacy to be low based on inconsistency and suspected publication bias. There was no significant difference in the risk of significant adverse events between vernakalant and comparator (RR 0.95; 95% CI 0.70-1.28, I2 = 0, moderate quality evidence). Vernakalant is safe and effective for rapid and durable restoration of sinus rhythm in patients with recent-onset AF.
Vernakalant should be a first line option for the pharmacological cardioversion of patients with haemodynamically stable recent-onset AF without severe structural heart disease.
评估维纳卡兰在心房颤动(AF)转复中的疗效和安全性。
我们检索了比较维纳卡兰与 AF 发作后≤7 天的其他药物或安慰剂的随机试验文献。我们使用随机效应模型对定量数据进行合并,并使用 GRADE(推荐、评估、发展和评价分级)对证据质量进行评级。在 MEDLINE、EMBASE 和 CENTRAL(2018 年 12 月)中检索到 441 项研究,共确定了 9 项试验,共纳入 1358 名患者。6 项试验比较了维纳卡兰与安慰剂,2 项试验比较了维纳卡兰与伊布利特,1 项试验比较了维纳卡兰与胺碘酮。我们发现 4 项试验存在明显的方法学偏倚。在 90 分钟内转复方面,维纳卡兰优于安慰剂[50%转复,风险比(RR)5.15;95%置信区间(CI)2.24-11.84,I2=91%],而与活性药物比较时,维纳卡兰无明显差异(56%vs.24%转复,RR 2.40;95%CI 0.76-7.58,I2=94%)。维纳卡兰急性转复的患者中有 85%(95%CI 80-88%)在 24 小时时维持窦性节律。总体而言,我们根据不一致性和可疑的发表偏倚,将疗效证据质量评为低级别。维纳卡兰与对照药物的严重不良事件风险无显著差异(RR 0.95;95%CI 0.70-1.28,I2=0,中质量证据)。维纳卡兰在近期发作的 AF 患者中安全且有效,可快速、持久地恢复窦性节律。
对于血流动力学稳定、无严重结构性心脏病的近期发作 AF 患者,维纳卡兰应作为首选药物进行药物转复。