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心房颤动患者窦性节律的预后影响:从 CABANA 试验中分离节律结果与随机策略发现。

Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial.

机构信息

Division of Cardiovascular Medicine, University of Utah School of Medicine, Salt Lake City (T.J.B.).

University of Washington Medical Center, Seattle (J.E.P.).

出版信息

Circ Arrhythm Electrophysiol. 2024 May;17(5):e012697. doi: 10.1161/CIRCEP.123.012697. Epub 2024 Apr 17.

DOI:10.1161/CIRCEP.123.012697
PMID:38629286
Abstract

BACKGROUND

Clinically detected atrial fibrillation (AF) is associated with a significant increase in mortality and other adverse cardiovascular events. Since the advent of effective methods for AF rhythm control, investigators have attempted to determine how much these adverse prognostic AF effects could be mitigated by the restoration of sinus rhythm (SR) and whether the method used mattered.

METHODS

The CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) randomized 2204 AF patients to ablation versus drug therapy, of which 1240 patients were monitored in follow-up using the CABANA ECG rhythm monitoring system. To assess the prognostic benefits of SR, we performed a prespecified analysis using Cox survival modeling with heart rhythm as a time-dependent variable and randomized treatment group as a stratification factor.

RESULTS

In the 1240 patient study cohort, 883 (71.2%) had documented AF at some point during their postblanking follow-up. Among the 883 patients, 671 (76.0%) experienced AF within the first year of postblanking follow-up, and 212 (24.0%) experienced their first AF after ≥1 year of postblanking follow-up. The primary CABANA end point (death, disabling stroke, serious bleeding, or cardiac arrest) occurred in 95 (10.8%) of the 883 patients with documented AF and in 29 (8.1%) of the 357 patients with no AF recorded during follow-up. In multivariable time-dependent analysis, the presence of SR (compared with non-SR) was associated with a significantly reduced risk of the primary end point (adjusted hazard ratio, 0.57 [95% CI, 0.38-0.85]; =0.006; independent of treatment strategy [ablation versus drugs]). Corresponding results for all-cause mortality were adjusted hazard ratio of 0.59 [95% CI, 0.35-1.01]; =0.053).

CONCLUSIONS

In patients in the CABANA trial with detailed long-term rhythm follow-up, increased time in SR was associated with a clinically consequential decrease in mortality and other adverse prognostic events. The predictive value of SR was independent of the therapeutic approach responsible for reducing the burden of detectable AF.

REGISTRATION

URL: https://clinicaltrials.gov; Unique Identifier: NCT00911508.

摘要

背景

临床检测到的心房颤动 (AF) 与死亡率和其他心血管不良事件显著增加有关。自有效的 AF 节律控制方法问世以来,研究人员一直在试图确定恢复窦性节律 (SR) 可以在多大程度上减轻这些不良预后 AF 影响,以及所使用的方法是否重要。

方法

CABANA 试验(导管消融与抗心律失常药物治疗心房颤动)将 2204 例 AF 患者随机分为消融与药物治疗组,其中 1240 例患者在随访中使用 CABANA ECG 节律监测系统进行监测。为了评估 SR 的预后益处,我们使用 Cox 生存模型进行了预设分析,将心律作为时间依赖性变量,并将随机治疗组作为分层因素。

结果

在 1240 例研究队列患者中,883 例(71.2%)在随访期间的某个时间点记录到 AF。在 883 例患者中,671 例(76.0%)在随访的第一年中经历了 AF,212 例(24.0%)在随访≥1 年后首次经历了 AF。主要 CABANA 终点(死亡、致残性卒中、严重出血或心脏骤停)发生在 883 例有记录 AF 的患者中的 95 例(10.8%)和 357 例无 AF 记录的患者中的 29 例(8.1%)。在多变量时间依赖性分析中,SR 的存在(与非-SR 相比)与主要终点风险显著降低相关(调整后的危险比,0.57[95%CI,0.38-0.85];=0.006;独立于治疗策略[消融与药物])。全因死亡率的相应结果为调整后的危险比 0.59[95%CI,0.35-1.01];=0.053)。

结论

在 CABANA 试验中接受详细长期节律随访的患者中,SR 时间的增加与死亡率和其他不良预后事件的临床相关降低相关。SR 的预测价值独立于负责降低可检测 AF 负担的治疗方法。

登记

网址:https://clinicaltrials.gov;唯一标识符:NCT00911508。

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