近日，加拿大渥太华大学Ian G Stiell团队比较了维那卡兰特与普鲁卡因胺用于急性房颤患者快速复律的效果。这一研究成果于2025年11月11日发表在《英国医学杂志》上。

研究组对急诊科静脉注射维那卡兰特和静脉注射普鲁卡因胺治疗急性心房颤动的有效性和安全性进行随机、开放标签比较，在加拿大的12个三级急诊部门进行了一项随机临床试验（RAFF4试验）。急性心房颤动患者的急性心律控制是一个安全的选择，患者随机（1:1）接受静脉输注维那卡兰特或普鲁卡因胺；当快速转阴没有发生时，患者被给予电复律。主要观察指标为药物输注完成后30分钟内窦性心律的恢复。次要结局包括转到窦性心律的时间和患者是否需要电复律。

在350名入选的符合条件的患者中，普鲁卡因胺组（n=172）和维那卡兰特组（n=178）的基线特征相似。对于转换成功的主要结局，维那卡兰特更有效（62.4% vs 48.3%；校正绝对差值15.0%，95%可信区间为4.6% ~ 25.0%，P=0.005；校正优势比1.87,95%可信区间为1.2 ~ 2.9，P=0.006）。使用维那卡兰特，转阴时间更快（21.8 v 44.7分钟；平均差值为22.9,95%可信区间为29.9至16.0,P<0.001），尝试电复律的患者更少（33.7% v 44.2%；优势比为0.62,95%可信区间为0.39至0.96，P=0.033）。两组的不良事件相似，一般都是轻微和短暂的，大多数患者出院回家。亚组分析强烈支持维那卡兰特对70岁以下患者的转化（73.3% vs 47.2%；校正优势比为3.1,95%可信区间为1.7 ~ 5.5，P=0.001，相互作用P=0.005）。

研究结果表明，在这个头对头比较中，维那卡兰特优于普鲁卡因胺的患者具有更高的转化率和更快的转化时间。因此，对于急性房颤患者的快速复心和出院而言，维那卡兰特是一种安全、高效的静脉替代药物。

附：英文原文

Title: Vernakalant versus procainamide for rapid cardioversion of patients with acute atrial fibrillation (RAFF4): randomised clinical trial

Author: Ian G Stiell, Monica Taljaard, Debra Eagles, Krishan Yadav, Alain Vadeboncoeur, Corinne M Hohl, Patrick M Archambault, David Birnie, Erica Brown, Samuel G Campbell, Yutong Chen, Catherine M Clement, Alexis Cournoyer, Kerstin de Wit, Marcel Emond, Laurent Macle, Andrew D McRae, Eric Mercier, Judy Morris, Ghadeer Mohamad, Marie-Joe Nemnom, Stuart G Nicholls, David Pare, Ratika Parkash, Marco LA Sivilotti, Kednapa Thavorn, Jeffrey J Perry

Issue&Volume: 2025/11/11

Abstract:

Objective To conduct a randomised, open label comparison of the effectiveness and safety of intravenous vernakalant and intravenous procainamide for the management of acute atrial fibrillation in the emergency department.

Design Randomised clinical trial (RAFF4 trial).

Setting 12 tertiary care emergency departments in Canada.

Participants Patients with acute atrial fibrillation for whom acute rhythm control was a safe option.

Interventions Patients were randomised (1:1) to an intravenous infusion of vernakalant or procainamide; when rapid conversion did not occur, patients were offered electrical cardioversion.

Main outcomes and measures The primary outcome was conversion to sinus rhythm within 30 minutes of drug infusion completion. Secondary outcomes included time to conversion to sinus rhythm and whether the patient required electrical cardioversion.

Results Of the 350 enrolled eligible patients, baseline characteristics were similar in the procainamide (n=172) and vernakalant (n=178) groups. For the primary outcome of conversion success, vernakalant was more effective (62.4% v 48.3%; adjusted absolute difference 15.0%, 95% confidence interval 4.6% to 25.0%, P=0.005; adjusted odds ratio 1.87, 95% confidence interval 1.2 to 2.9, P=0.006). With vernakalant, time to conversion was faster (21.8 v 44.7 minutes; mean difference 22.9, 95% confidence interval 29.9 to 16.0, P<0.001), and fewer patients underwent attempted electrical cardioversion (33.7% v 44.2%; odds ratio 0.62, 95% confidence interval 0.39 to 0.96, P=0.033). Adverse events were similar in both groups, were generally mild and brief, and most patients were discharged home. Subgroup analysis strongly favoured vernakalant for conversion in patients younger than 70 years (73.3% v 47.2%; adjusted odds ratio 3.1, 95% confidence interval 1.7 to 5.5, P=0.001, interaction P=0.005).

Conclusions In this head-to-head comparison, vernakalant was superior to procainamide for patients with higher conversion rates and faster times to conversion. Therefore, vernakalant is a safe and highly effective intravenous alternative for the rapid cardioversion and discharge home of patients with acute atrial fibrillation.

DOI: 10.1136/bmj-2025-085632

Source: https://www.bmj.com/content/391/bmj-2025-085632