Akel Tamer, Lafferty James
Department of Internal Medicine, Staten Island University Hospital, Staten Island, NY, USA.
Department of Cardiology, Staten Island University Hospital, NY, USA.
Ann Noninvasive Electrocardiol. 2018 May;23(3):e12508. doi: 10.1111/anec.12508. Epub 2017 Nov 4.
Atrial fibrillation is a common cardiac arrhythmia with increasing prevalence in the aging population. It is a major cause of emergency department visits worldwide. Vernakalant, a relatively new antiarrhythmic drug with selectively preferential effects on the atrial tissue is currently used in many European countries for the termination of recent-onset atrial fibrillation. Presently, the drug is still not approved by the United States Food and Drug Administration due to safety concerns. We evaluate the efficacy and safety of vernakalant for the conversion of recent-onset atrial fibrillation or atrial flutter into normal sinus rhythm (NSR).
PubMed/MEDLINE (1993-2017), the Cochrane Central Register of Controlled Trials (2000-2017), and reference lists of relevant articles were searched for randomized controlled trials (RCTs) comparing vernakalant to a control drug and extracted subsequently.
Nine RCTs were identified and included in the meta-analysis. Pooled analysis of events extracted for a total of 1421 patients with recent-onset atrial fibrillation showed a statistically significant increase in cardioversion within 90 minutes from drug infusion (Relative Risk [RR], 6.61; 95% Confidence Interval [CI], 2.78 - 15.71; p < .00001). In terms of adverse events, vernakalant was considered safe in comparison to control drugs (RR, 0.80; 95% CI, 0.61-1.05; p = .11).
Vernakalant is effective for rapid conversion of recent-onset atrial fibrillation into NSR. However, although it showed a safe profile in terms of side effects in this analysis, we are still hesitant about this conclusion and few safety issues should be addressed within specific patients' subgroups.
心房颤动是一种常见的心律失常,在老年人群中的患病率不断上升。它是全球急诊就诊的主要原因。维纳卡兰是一种相对较新的抗心律失常药物,对心房组织具有选择性优先作用,目前在许多欧洲国家用于终止近期发作的心房颤动。目前,由于安全问题,该药物仍未获得美国食品药品监督管理局的批准。我们评估维纳卡兰将近期发作的心房颤动或心房扑动转为正常窦性心律(NSR)的疗效和安全性。
检索PubMed/MEDLINE(1993 - 2017年)、Cochrane对照试验中心注册库(2000 - 2017年)以及相关文章的参考文献列表,查找比较维纳卡兰与对照药物的随机对照试验(RCT),随后进行提取。
共识别出9项RCT并纳入荟萃分析。对总共1421例近期发作心房颤动患者提取的事件进行汇总分析显示,从药物输注开始90分钟内心律转复有统计学显著增加(相对风险[RR],6.61;95%置信区间[CI],2.78 - 15.71;p <.00001)。在不良事件方面,与对照药物相比,维纳卡兰被认为是安全的(RR,0.80;95% CI,0.61 - 1.05;p = 0.11)。
维纳卡兰对近期发作的心房颤动快速转复为NSR有效。然而,尽管在该分析中其副作用显示出安全概况,但我们对这一结论仍持犹豫态度,并且在特定患者亚组中应解决一些安全问题。