20 / 10 / 16
关于“近期发生心房颤动患者的早期或延迟复律”一文医学翻译摘要学习情况,记录于此。
Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation
背景
近期发生心房颤动的患者通常通过药物复律或电复律的方式立即恢复窦性心律。然而,窦性心律是否需要立即恢复尚不清楚,因为心房颤动往往会自行终止。
BACKGROUND
Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously.
笔记:
方法
在一项多中心、随机、开放标签、非劣效性试验中,我们将血流动力学稳定、近期发生(<36小时)有症状心房颤动的急诊患者随机分组,分别接受观察等待疗法(延迟复律组)或早期复律。观察等待疗法指的是仅使用心率控制药物进行初步治疗,如果心房颤动在48小时内未缓解,则采用延迟复律。主要终点是4周时的窦性心律。如果主要终点组间差异的95%置信区间下限大于-10个百分点,则证实非劣效性。
METHODS
In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than −10.
笔记:
结果
4周时,延迟复律组212例患者中的193例(91%)和早期复律组215例患者中的202例(94%)为窦性心律(组间差异,-2.9个百分点;95%置信区间[CI],-8.2~2.2;对于非劣效性,P=0.005)。在延迟复律组中,218例患者中的150例(69%)在48小时内自发转复为窦性心律,61例(28%)在延迟复律后转复为窦性心律。在早期复律组中,219例患者中的36例(16%)在开始复律前转复为窦性心律,171例(78%)在复律后转复为窦性心律。在4周随访期间完成远程监测的患者中,延迟复律组164例患者中的49例(30%)和早期复律组171例患者中的50例(29%)有心房颤动复发。在随机分组后4周内,两组分别有10例患者和8例患者出现了心血管并发症。
RESULTS
The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, −2.9 percentage points; 95% confidence interval [CI], −8.2 to 2.2; P=0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the early-cardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early-cardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively.
笔记:
结论
在近期发生有症状心房颤动的急诊患者中,在4周时恢复窦性心律方面,观察等待疗法不劣于早期复律(由荷兰健康研究和开发组织[Netherlands Organization for Health Research and Development]等资助;RACE 7 ACWAS在ClinicalTrials.gov注册号为NCT02248753)。
CONCLUSIONS
In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753 .)
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