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

Methods

Randomised clinical trial (RAFF4 trial).

随机临床试验（RAFF4试验）。

12 tertiary care emergency departments in Canada.

加拿大的12家三级护理急诊部门。

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

对于那些急性房颤患者，急性节律控制是一个安全的选择。

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

患者被随机分配（1:1）接受静脉注射维纳卡兰或普鲁卡因胺；当快速转复未发生时，患者被提供电复律。

main_outcomes_and_measures

The primary outcome was conversion to sinus rhythm within 30 minutes of drug infusion completion.

主要结果是在药物输注完成后30分钟内转复为窦性心律。

Secondary outcomes included time to conversion to sinus rhythm and whether the patient required electrical cardioversion.

次要结果包括转复窦性心律的时间以及患者是否需要电复律。

Results

Of the 350 enrolled eligible patients, baseline characteristics were similar in the procainamide (n=172) and vernakalant (n=178) groups.

在350名符合条件的入组患者中，普罗卡因胺组（n=172）和维纳卡兰特组（n=178）的基线特征相似。

For the primary outcome of conversion success, vernakalant was more effective (62.4% v 48.3%; adjusted absolute difference 15.0%, 95% confidence interval4.6% to 25.0%, P=0.005; adjusted odds ratio 1.87, 95% confidence interval1.2 to 2.9, P=0.006).

在主要结果的转复成功率方面，Vernakalant更为有效（62.4%对比48.3%；调整后的绝对差异为15.0%，95%置信区间为4.6%至25.0%，P=0.005；调整后的优势比为1.87，95%置信区间为1.2至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 interval0.39 to 0.96, P=0.033).

使用Vernakalant，转复时间更快（21.8分钟对比44.7分钟；平均差异为-22.9分钟，95%置信区间为-29.9至-16.0，P<0.001），并且尝试电转复的患者更少（33.7%对比44.2%；优势比为0.62，95%置信区间为0.39至0.96，P=0.033）。

Adverse events were similar in both groups, were generally mild and brief, and most patients were discharged home.

两组的不良事件相似，通常都是轻微且短暂的，大多数患者可以出院回家。

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 interval1.7 to 5.5, P=0.001, interaction P=0.005).

亚组分析强烈支持70岁以下患者使用vernakalant进行转复（73.3%对比47.2%；调整后的优势比为3.1，95%置信区间1.7至5.5，P=0.001，交互作用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.

在这项头对头比较中，维纳卡兰对于转复率较高的患者比普罗卡因胺更优越，且转复时间更快。

Therefore, vernakalant is a safe and highly effective intravenous alternative for the rapid cardioversion and discharge home of patients with acute atrial fibrillation.

因此，维纳卡兰是急性心房颤动患者快速复律和出院回家的安全且高效的静脉注射替代药物。

trial_registration

ClinicalTrials.gov NCT04485195.

临床试验注册号 NCT04485195。