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导管消融或药物治疗延缓心房颤动进展:随机对照心房颤动进展试验(ATTEST)。

Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST).

机构信息

Department of Cardiology, Asklepios Klinik St. Georg, LANS Cardio, Stephansplatz 5, 20354 Hamburg, Germany.

Almazov National Medical Research Centre, St. Petersburg, Russia.

出版信息

Europace. 2021 Mar 8;23(3):362-369. doi: 10.1093/europace/euaa298.

Abstract

AIMS

Delay of progression from paroxysmal to persistent atrial fibrillation (AF) is an important measure of long-term success of AF treatment. However, published data on the impact of catheter ablation on AF progression are limited. This study evaluates whether radiofrequency (RF) catheter ablation delays the progression of AF compared with antiarrhythmic drug (AAD) treatment using current AF management guidelines.

METHODS

This prospective, randomized, controlled, two-arm, open-label trial was conducted at 29 hospitals and medical centres across 13 countries. Patients were randomized 1 : 1 to RF ablation or AAD treatment. The primary endpoint was the rate of persistent AF/atrial tachycardia (AT) at 3 years.

RESULTS

After early study termination following slow enrolment, 255 (79%) of the planned 322 patients were enrolled (RF ablation, n = 128, AAD, n = 127); 36% of patients in the RF ablation group and 41% in the AAD group completed 3 years of follow-up. For the primary endpoint, the Kaplan-Meier estimate of the rate of persistent AF/AT at 3 years was significantly lower with RF ablation [2.4% (95% confidence interval (CI), 0.6-9.4%)] than with AAD therapy [17.5% (95% CI, 10.7-27.9%); one-sided P = 0.0009]. Patients ≥65 years were ∼4 times more likely to progress to persistent AF/AT than patients <65 years, suggesting RF ablation can delay disease progression [hazard ratio: 3.87 (95% CI, 0.88-17.00); P = 0.0727]. Primary adverse events were reported for eight patients in the RF ablation group.

CONCLUSIONS

Radiofrequency ablation is superior to guideline-directed AAD therapy in delaying the progression from paroxysmal to persistent AF.

摘要

目的

从阵发性到持续性心房颤动(AF)的进展延迟是 AF 治疗长期成功的重要衡量标准。然而,目前关于导管消融对 AF 进展影响的数据有限。本研究评估了与使用当前 AF 管理指南的抗心律失常药物(AAD)治疗相比,射频(RF)导管消融是否延迟 AF 的进展。

方法

这项前瞻性、随机、对照、双臂、开放标签试验在 13 个国家的 29 家医院和医疗中心进行。患者以 1:1 的比例随机分配至 RF 消融或 AAD 治疗。主要终点是 3 年时持续性 AF/房性心动过速(AT)的发生率。

结果

在招募缓慢导致早期研究终止后,计划的 322 例患者中有 255 例(79%)入组(RF 消融组 n=128,AAD 组 n=127);RF 消融组和 AAD 组分别有 36%和 41%的患者完成了 3 年的随访。对于主要终点,3 年时持续性 AF/AT 的 Kaplan-Meier 估计率在 RF 消融组显著低于 AAD 治疗组[2.4%(95%置信区间[CI],0.6-9.4%)] [17.5%(95% CI,10.7-27.9%);单侧 P=0.0009]。≥65 岁的患者比<65 岁的患者进展为持续性 AF/AT 的可能性高约 4 倍,提示 RF 消融可延迟疾病进展[风险比:3.87(95% CI,0.88-17.00);P=0.0727]。在 RF 消融组报告了 8 例患者的主要不良事件。

结论

与指南指导的 AAD 治疗相比,RF 消融在延迟阵发性 AF 向持续性 AF 进展方面更具优势。

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