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心脏再同步治疗在有房颤病史患者中的应用:四项主要临床试验的结果。

Cardiac resynchronization therapy in patients with a prior history of atrial fibrillation: Insights from four major clinical trials.

机构信息

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.

Department of Cardiology, Herlev and Gentofte Hospital, Copenhagen, Denmark.

出版信息

J Cardiovasc Electrophysiol. 2023 Sep;34(9):1914-1924. doi: 10.1111/jce.16022. Epub 2023 Jul 31.

Abstract

AIMS

To investigate the association of cardiac resynchronization therapy (CRT) on outcomes among participants with and without a history of atrial fibrillation (AF).

METHODS

Individual-patient-data from four randomized trials investigating CRT-Defibrillators (COMPANION, MADIT-CRT, REVERSE) or CRT-Pacemakers (COMPANION, MIRACLE) were analyzed. Outcomes were time to a composite of heart failure hospitalization or all-cause mortality or to all-cause mortality alone. The association of CRT on outcomes for patients with and without a history of AF was assessed using a Bayesian-Weibull survival regression model adjusting for baseline characteristics.

RESULTS

Of 3964 patients included, 586 (14.8%) had a history of AF; 2245 (66%) were randomized to CRT. Overall, CRT reduced the risk of the primary composite endpoint (hazard ratio [HR]: 0.69, 95% credible interval [CI]: 0.56-0.81). The effect was similar (posterior probability of no interaction = 0.26) in patients with (HR: 0.78, 95% CI: 0.55-1.10) and without a history of AF (HR: 0.67, 95% CI: 0.55-0.80). In these four trials, CRT did not reduce mortality overall (HR: 0.82, 95% CI: 0.66-1.01) without evidence of interaction (posterior probability of no interaction = 0.14) for patients with (HR: 1.09, 95% CI: 0.70-1.74) or without a history of AF (HR: 0.70, 95% CI: 0.60-0.97).

CONCLUSION

The association of CRT on the composite endpoint or mortality was not statistically different for patients with or without a history of AF, but this could reflect inadequate power. Our results call for trials to confirm the benefit of CRT recipients with a history of AF.

摘要

目的

研究心脏再同步治疗(CRT)对伴有或不伴有心房颤动(AF)病史的患者结局的影响。

方法

对四项随机临床试验(COMPANION、MADIT-CRT、REVERSE 研究调查 CRT 除颤器,以及 COMPANION、MIRACLE 研究调查 CRT 起搏器)的个体患者数据进行分析。结局为心力衰竭住院或全因死亡率或全因死亡率的复合终点。使用贝叶斯威布尔生存回归模型,根据基线特征调整,评估 CRT 对伴有和不伴有 AF 病史患者结局的关联。

结果

纳入 3964 例患者中,586 例(14.8%)有 AF 病史;2245 例(66%)被随机分配至 CRT 组。总体而言,CRT 降低了主要复合终点的风险(风险比 [HR]:0.69,95%可信区间 [CI]:0.56-0.81)。在伴有(HR:0.78,95% CI:0.55-1.10)和不伴有 AF 病史的患者中(HR:0.67,95% CI:0.55-0.80),该效果相似(无交互作用的后验概率=0.26)。在这四项试验中,CRT 并未降低总体死亡率(HR:0.82,95% CI:0.66-1.01),对伴有(HR:1.09,95% CI:0.70-1.74)或不伴有 AF 病史(HR:0.70,95% CI:0.60-0.97)的患者均无交互作用证据(无交互作用的后验概率=0.14)。

结论

对于伴有或不伴有 AF 病史的患者,CRT 对复合终点或死亡率的影响在统计学上无差异,但这可能反映出效力不足。我们的研究结果呼吁开展临床试验以确认伴有 AF 病史的 CRT 受者的获益。

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Cardiac Resynchronization in Patients with Atrial Fibrillation.心房颤动患者的心脏再同步治疗
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