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一项随机对照试验中冠状动脉旁路移植术后心房颤动的发生率及转归:盲法终末期分析

Incidence and Outcomes of Postoperative Atrial Fibrillation after Coronary Artery Bypass Grafting of a Randomized Controlled Trial: A Blinded End-of-cycle Analysis.

作者信息

Musa Ahmad Farouk, Dillon Jeswant, Taib Mohamed Ezani Md, Yunus Alwi Mohamed, Sanusi Abdul Rais, Nordin Mohd Nazeri, Smith Julian A

机构信息

Jeffrey Cheah School of Medicine & Health Sciences, Monash University Malaysia, 47500 Subang Jaya, Selangor, Malaysia.

Victorian Heart Institute, Monash University, 3168 Melbourne, Australia.

出版信息

Rev Cardiovasc Med. 2022 Apr 1;23(4):122. doi: 10.31083/j.rcm2304122. eCollection 2022 Apr.

DOI:10.31083/j.rcm2304122
PMID:39076222
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11273857/
Abstract

OBJECTIVE

The objective of this study is to analyse the incidence of postoperative atrial fibrillation (POAF), demography, post-operative outcomes including morbidity and mortality, length of Cardiac Intensive Care Unit (CICU) stay, High Dependency Unit (HDU) stay, and total hospital stay in patients undergoing coronary bypass grafting (CABG) at Institut Jantung Negana (IJN).

METHODS

We conducted a prospective, randomised, controlled trial. We supplied the treatment group with Tocovid capsules and the control group with placebo containing palm superolein.

RESULTS

Since January 2019, we have recruited the target population of 250 patients. However, the result is still blinded as we are still analysing blood samples for tocotrienol levels. 89.2% of patients completed the study with a 3.6% mortality and a 7.6% attrition rate. 35.2% of the patients developed POAF, the mean time being 46.06 26.96 hours post-CABG. We did not observe any statistically significant difference when we compared left atrial size, New York Heart Association (NYHA) functional class, ejection fraction and premorbid history, besides EuroSCORE II (The European System for Cardiac Operative Risk Evaluation II) status except for older age group, right atrial size, and pleural effusion. There was also no difference in bypass time, cross clamp time or number of anastomoses. However, we noted a significant difference in death ( = 0.01) and renal failure requiring dialysis ( = 0.007) among patients with POAF; those patients also had a longer CICU stay ( = 0.005), HDU stay ( = 0.02), and total hospital stay ( = 0.001).

CONCLUSIONS

POAF is associated with a higher incidence of renal failure and death while it increases CICU, HDU, and total hospital stay. It remains to be seen whether Tocovid reduces POAF and its associated sequelae.

CLINICAL TRIAL REGISTRATION

NCT03807037 (Registered on 16 January 2019).

摘要

目的

本研究旨在分析马来西亚国家心脏研究所(IJN)接受冠状动脉旁路移植术(CABG)患者的术后房颤(POAF)发生率、人口统计学特征、术后结局(包括发病率和死亡率)、心脏重症监护病房(CICU)住院时间、高依赖病房(HDU)住院时间以及总住院时间。

方法

我们进行了一项前瞻性、随机、对照试验。我们为治疗组提供Tocovid胶囊,为对照组提供含棕榈油精的安慰剂。

结果

自2019年1月以来,我们招募了250名目标患者。然而,由于我们仍在分析血样中的生育三烯酚水平,结果仍处于盲态。89.2%的患者完成了研究,死亡率为3.6%,失访率为7.6%。35.2%的患者发生了POAF,平均时间为CABG术后46.06±26.96小时。除了老年组、右心房大小和胸腔积液外,当我们比较左心房大小、纽约心脏协会(NYHA)功能分级、射血分数和病前病史以及欧洲心脏手术风险评估系统II(EuroSCORE II)状态时,未观察到任何统计学上的显著差异。搭桥时间、交叉夹闭时间或吻合口数量也没有差异。然而,我们注意到POAF患者在死亡(P = 0.01)和需要透析的肾衰竭(P = 0.007)方面存在显著差异;这些患者的CICU住院时间(P = 0.005)、HDU住院时间(P = 0.02)和总住院时间(P = 0.001)也更长。

结论

POAF与肾衰竭和死亡的发生率较高相关,同时它会增加CICU、HDU和总住院时间。Tocovid是否能降低POAF及其相关后遗症还有待观察。

临床试验注册

NCT03807037(于2019年1月16日注册)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6217/11273857/ced7bf7e021d/2153-8174-23-4-122-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6217/11273857/ced7bf7e021d/2153-8174-23-4-122-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6217/11273857/ced7bf7e021d/2153-8174-23-4-122-g1.jpg

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