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非体外循环与体外循环冠状动脉旁路移植术治疗左主干冠状动脉疾病患者的随机对照试验。

Off-Pump Versus On-Pump Coronary Artery Bypass Grafting In Patients With Left Main Coronary Artery Disease: A Randomized Controlled Trial.

机构信息

Department of Cardiothoracic Surgery, Kafrelsheikh University,Egypt.

出版信息

J Pak Med Assoc. 2023 Apr;73(Suppl 4)(4):S22-S25. doi: 10.47391/JPMA.EGY-S4-5.

DOI:10.47391/JPMA.EGY-S4-5
PMID:37482823
Abstract

OBJECTIVES

To compare the outcome of off-pump and on-pump coronary artery bypass graftsurgery in patients with left main coronary artery disease.

METHODS

The randomised, controlled, prospective, multicentric study was conducted in 2020 during the period from January 2020 to December 2020 at Kafrelsheikh University Hospital, International Cardiac Centre and Alexandria New Medical Centre, Egypt, and comprised patients with left main coronary artery disease who underwent coronary artery bypass graftsurgery. The patients were randomised to on-pump surgery group I (Control Group) and off-pump surgery group II(Interventional Group). All patients were assessed pre-operatively for the presence of comorbid conditions and post-operatively for myocardial infarction, acute kidney injury, pneumonia, sternal dehiscence and 3-month mortality. Data was analysed using SPSS 20.

RESULTS

Of the 60 patients, 44(73.3%) were men and 16(26.6%) were women. The overall mean age was 66.4±9.2 years. There were 30(50%) patients in each of the two groups. There were 2(6.7%) cases of myocardial infarction in group I and 1(3.3%) in group II. There was 1(3.3%) case of acute kidney injury in group I and none in group II. There were 3(10%) cases of pneumonia in group 1 compared to 1(3.3%) in group II. There was 1(3.3%) case of sternal dehiscence in group I and none in group II. Mortality at 3 months was 2(6.7%) in group I and 1(3.3%) in group II. There was no significant difference with respect to outcome between the groups (p>0.05).

CONCLUSIONS

Off-pump coronary artery bypass graft surgery was found to be efficient and non-inferior to on-pump procedure in patients with left main coronary artery disease.

RCT REGISTRATION

The RCT was registered retrospectively at the Pan African Clinical Trials Registry (PACTR) (Trial #: PACTR202301506140749 Date of Approval: 06/01/2023). Link: https://pactr.samrc.ac.za/Search.aspx.

摘要

目的

比较非体外循环冠状动脉旁路移植术和体外循环冠状动脉旁路移植术治疗左主干冠状动脉疾病患者的结果。

方法

这是一项在 2020 年 1 月至 12 月期间,在埃及卡夫拉谢赫大学医院、国际心脏中心和亚历山大新医疗中心进行的随机、对照、前瞻性、多中心研究,纳入了接受冠状动脉旁路移植术的左主干冠状动脉疾病患者。将患者随机分为体外循环手术组 I(对照组)和非体外循环手术组 II(干预组)。所有患者术前评估合并症情况,术后评估心肌梗死、急性肾损伤、肺炎、胸骨裂开和 3 个月死亡率。数据使用 SPSS 20 进行分析。

结果

60 例患者中,44 例(73.3%)为男性,16 例(26.6%)为女性。总体平均年龄为 66.4±9.2 岁。两组各有 30 例(50%)患者。对照组有 2 例(6.7%)发生心肌梗死,干预组有 1 例(3.3%)。对照组有 1 例(3.3%)发生急性肾损伤,干预组无。对照组有 3 例(10%)发生肺炎,干预组有 1 例(3.3%)。对照组有 1 例(3.3%)胸骨裂开,干预组无。对照组 3 个月死亡率为 2 例(6.7%),干预组为 1 例(3.3%)。两组之间的结果无显著差异(p>0.05)。

结论

非体外循环冠状动脉旁路移植术治疗左主干冠状动脉疾病患者效果良好,不逊于体外循环手术。

RCT 注册:该 RCT 作为回顾性研究,在泛非临床试验注册处(PACTR)(注册号:PACTR202301506140749,批准日期:2023 年 1 月 6 日)注册。链接:https://pactr.samrc.ac.za/Search.aspx。

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