心房颤动患者的早期节律控制治疗。

Early Rhythm-Control Therapy in Patients with Atrial Fibrillation.

机构信息

From the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg-Eppendorf, LANS Cardio (K.-H.K.), and the Department of Cardiology, Asklepios Klinik St. Georg (S.W.), Hamburg, Atrial Fibrillation Network (AFNET) (P.K., A.G., L.E., T.F., D.H., K.-H.K., N.S., U.S., J.T., K.W., S.W., G.B.) and the Department of Cardiology II (Electrophysiology), University Hospital Münster (L.E., G.B.), Münster, the German Center of Cardiovascular Research, Partner Site Hamburg/Lübeck/Kiel (P.K., K.W., S.W.), St. Vincenz Hospital, Paderborn (A.G.), the Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg (A.G.), the Clinical Research Institute, Munich (T.F.), Hospital Konstanz, Konstanz (F.H.), the Department of Cardiology and Electrophysiology, University Heart Center-Helios, and Leipzig Heart Institute, Leipzig (G.H.), University Heart Center Schleswig-Holstein, Campus Lübeck, Lübeck (K.-H.K.), Cardiology Practice Schön, Mühldorf (N.S.), and Cardiology Practice Taggeselle, Markkleeberg (J.T.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London (A.J.C.), and the Department of Cardiovascular Sciences, University of Leicester, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester (G.A.N.) - all in the United Kingdom; the Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense (A.B.); Isala Hospital and Diagram B.V., Zwolle (A.E.), the University of Groningen, University Medical Center Groningen, Groningen (I.C.G.), and the Department of Physiology, Cardiovascular Research Institute Maastricht (U.S.), and the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht (H.J.G.M.C.), Maastricht - all in the Netherlands; University Hospital Zurich, Zurich (L.M.H.), and the Division of Cardiology, Medical University Department, Kantonsspital Aarau, Aarau (L.M.H.) - both in Switzerland; University Hospital Antwerp and Antwerp University, Antwerp, Belgium (H.H.); the Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.); the Hospital Clinic, University of Barcelona and Institut de Recerca Biomèdica, August Pi-Sunyer, Barcelona (L.M.), and Centro Investigación Biomedica en Red Cardiovascular, Madrid (L.M.); Department of Cardiology, Hospital Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego (WSRiTS) Meditrans, Warsaw, Poland (J.R.); the Department of Cardiology, Ospedale dell'Angelo, Venice, Italy (S.T.); and Heart Sector, Hygeia Hospitals Group, Athens (P.V.).

出版信息

N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.

DOI:10.1056/NEJMoa2019422

PMID:32865375

Abstract

BACKGROUND

Despite improvements in the management of atrial fibrillation, patients with this condition remain at increased risk for cardiovascular complications. It is unclear whether early rhythm-control therapy can reduce this risk.

METHODS

In this international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial, we randomly assigned patients who had early atrial fibrillation (diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either early rhythm control or usual care. Early rhythm control included treatment with antiarrhythmic drugs or atrial fibrillation ablation after randomization. Usual care limited rhythm control to the management of atrial fibrillation-related symptoms. The first primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome; the second primary outcome was the number of nights spent in the hospital per year. The primary safety outcome was a composite of death, stroke, or serious adverse events related to rhythm-control therapy. Secondary outcomes, including symptoms and left ventricular function, were also evaluated.

RESULTS

In 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization. The trial was stopped for efficacy at the third interim analysis after a median of 5.1 years of follow-up per patient. A first-primary-outcome event occurred in 249 of the patients assigned to early rhythm control (3.9 per 100 person-years) and in 316 patients assigned to usual care (5.0 per 100 person-years) (hazard ratio, 0.79; 96% confidence interval, 0.66 to 0.94; P = 0.005). The mean (±SD) number of nights spent in the hospital did not differ significantly between the groups (5.8±21.9 and 5.1±15.5 days per year, respectively; P = 0.23). The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care. Symptoms and left ventricular function at 2 years did not differ significantly between the groups.

CONCLUSIONS

Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions. (Funded by the German Ministry of Education and Research and others; EAST-AFNET 4 ISRCTN number, ISRCTN04708680; ClinicalTrials.gov number, NCT01288352; EudraCT number, 2010-021258-20.).

摘要

背景

尽管心房颤动的管理有所改善，但患有这种疾病的患者仍然存在心血管并发症的风险增加。目前尚不清楚早期节律控制治疗是否可以降低这种风险。

方法

在这项国际、由研究者发起的、平行组、开放、盲法结局评估试验中，我们随机分配了患有早期心房颤动（在入组前 1 年内诊断）和心血管疾病的患者，分别接受早期节律控制或常规治疗。早期节律控制包括在随机分组后使用抗心律失常药物或心房颤动消融治疗。常规治疗将节律控制仅限于心房颤动相关症状的管理。主要复合终点是心血管原因死亡、中风或因心力衰竭或急性冠状动脉综合征恶化而住院；次要复合终点是每年住院夜数。主要安全性终点是死亡、中风或与节律控制治疗相关的严重不良事件的复合终点。还评估了次要结局，包括症状和左心室功能。

结果

在 135 个中心，2789 名患有早期心房颤动（诊断后中位时间 36 天）的患者接受了随机分组。在中位随访 5.1 年后，在第三次中期分析时因疗效停止试验。接受早期节律控制治疗的患者中有 249 例（每 100 人年 3.9 例）和接受常规治疗的患者中有 316 例（每 100 人年 5.0 例）发生了主要复合终点事件（风险比 0.79；96%置信区间 0.66 至 0.94；P=0.005）。两组之间住院夜数无显著差异（分别为每年 5.8±21.9 和 5.1±15.5 天；P=0.23）。两组之间主要安全性终点事件的发生率无显著差异；接受早期节律控制治疗的患者中有 4.9%发生与节律控制治疗相关的严重不良事件，而接受常规治疗的患者中有 1.4%发生。两组在 2 年时的症状和左心室功能无显著差异。

结论

在患有早期心房颤动和心血管疾病的患者中，早期节律控制治疗与常规治疗相比，不良心血管结局的风险较低。（由德国联邦教育与研究部和其他机构资助；EAST-AFNET 4 ISRCTN 编号，ISRCTN04708680；ClinicalTrials.gov 编号，NCT01288352；EudraCT 编号，2010-021258-20。）