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早期节律控制可改善房颤患者的预后
作者:小柯机器人 发布时间:2020/9/3 14:03:52

德国汉堡大学Paulus Kirchhof团队研究了早期节律控制治疗房颤患者的疗效。2020年8月29日,《新英格兰医学杂志》发表了该成果。

尽管房颤管理有所改善,但房颤患者仍然有增加心血管并发症的风险。目前尚不清楚早期节律控制疗法是否可以降低这种风险。

在这项国际、研究者发起、平行组、开放、结局评估盲的试验中,研究组在135个中心招募了2789例早期房颤(1年内确诊)和心血管疾病的患者,将其随机分组,分别接受早期节律控制(使用抗心律失常药或房颤消融治疗)或常规治疗。第一个主要结局为心血管原因死亡、中风或因心衰加重或急性冠状动脉综合征而住院的综合结局。第二个主要结局为每年的住院过夜天数。

中位随访5.1年后,早期节律控制组中有249名患者(每100人年3.9人)发生第一个主要结局,显著低于常规治疗组(316名,每100人年5.0人)。两组间每年住院过夜天数无显著差异,主要安全结局亦无显著差异。早期节律控制组中有4.9%的患者发生与节律控制相关的严重不良事件,而常规治疗组中仅有1.4%。两组间患者症状和2年时左心室功能无明显差异。

总之,早期节律控制可降低与早期房颤和心血管疾病患者的心血管疾病风险。

附:英文原文

Title: Early Rhythm-Control Therapy in Patients with Atrial Fibrillation | NEJM

Author: Paulus Kirchhof, M.D.,, A. John Camm, M.D.,, Andreas Goette, M.D.,, Axel Brandes, M.D.,, Lars Eckardt, M.D.,, Arif Elvan, M.D.,, Thomas Fetsch, M.D.,, Isabelle C. van Gelder, M.D.,, Doreen Haase, Ph.D.,, Laurent M. Haegeli, M.D.,, Frank Hamann, M.D.,, Hein Heidbüchel, M.D., Ph.D.,, Gerhard Hindricks, M.D.,, Josef Kautzner, M.D.,, Karl-Heinz Kuck, M.D.,, Lluis Mont, M.D.,, G. Andre Ng, M.B., Ch.B., Ph.D.,, Jerzy Rekosz, M.D.,, Norbert Schoen, M.D.,, Ulrich Schotten, M.D., Ph.D.,, Anna Suling, Ph.D.,, Jens Taggeselle, M.D.,, Sakis Themistoclakis, M.D.,, Eik Vettorazzi, M.Sc.,, Panos Vardas, M.D., Ph.D.,, Karl Wegscheider, Ph.D.,, Stephan Willems, M.D.,, Harry J.G.M. Crijns, M.D., Ph.D.,, and Günter Breithardt, M.D.

Issue&Volume: 2020-08-29

Abstract: 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 cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions.

DOI: 10.1056/NEJMoa2019422

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2019422

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home