近期发作心房颤动的早期或延迟电复律。

Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation.

机构信息

From the Departments of Cardiology (N.A.H.A.P., E.A.M.P.D., J.G.L.M.L., H.J.G.M.C.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), the Cardiovascular Research Institute Maastricht (N.A.H.A.P., E.A.M.P.D., J.G.L.M.L., H.J.G.M.C.), Maastricht University Medical Center, Maastricht, VieCuri Medical Center Noord-Limburg, Venlo (J.G.M.), Zuyderland Medical Center, Heerlen (T.L.), Elisabeth-TweeSteden Hospital, Tilburg (J.W.), Diakonessen Hospital, Utrecht (J.J.J.B.), University of Groningen, Groningen (M.R., I.C.V.G.), VU University Medical Center Amsterdam (O.K.) and Academic Medical Center (J.G.P.T), Amsterdam, Medical Spectrum Twente, Enschede (J.M.V.O.), Amphia Hospital, Breda (M.A.), Antonius Hospital, Sneek (A.O.), Alrijne Hospital, Leiderdorp (C.J.K.), St. Antonius Hospital, Nieuwegein (V.F.V.D.), Haga Teaching Hospital, The Hague (H.R.), St. Franciscus Gasthuis, Rotterdam (A.L.), and Catharina Hospital, Eindhoven (L.R.D) - all in the Netherlands.

出版信息

N Engl J Med. 2019 Apr 18;380(16):1499-1508. doi: 10.1056/NEJMoa1900353. Epub 2019 Mar 18.

DOI:10.1056/NEJMoa1900353

PMID:30883054

Abstract

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.

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.

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.

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.).

摘要

背景

新发心房颤动患者常通过药物或电复律立即恢复窦性节律。然而，尚不清楚是否需要立即恢复窦性节律，因为心房颤动通常会自行终止。

方法

在一项多中心、随机、开放标签、非劣效性试验中，我们将急诊科血流动力学稳定、新发（<36 小时）、有症状的心房颤动患者随机分为等待观察组（延迟复律组）或早期复律组。等待观察组仅采用控制心室率的药物初始治疗，如果心房颤动在 48 小时内未缓解，则延迟复律。主要终点为 4 周时窦性节律的存在。如果主要终点的组间差异的 95%置信区间下限为百分点，则下限大于-10%，则表明非劣效性。

结果

在延迟复律组的 212 名患者中有 193 名（91%）和在早期复律组的 215 名患者中有 202 名（94%）在 4 周时出现窦性节律（组间差异，-2.9%；95%置信区间[CI]，-8.2 至 2.2；P=0.005，用于非劣效性）。在延迟复律组中，150 名患者（69%）在 48 小时内自发转为窦性心律，61 名患者（28%）在延迟复律后转为窦性心律。在早期复律组中，36 名患者（16%）在开始复律前，171 名患者（78%）在复律后自发转为窦性心律。在接受 4 周随访远程监测的患者中，延迟复律组的 164 名患者中有 49 名（30%）和早期复律组的 171 名患者中有 50 名（29%）在 4 周内再次出现心房颤动。随机分组后 4 周内，分别有 10 名和 8 名患者发生心血管并发症。