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冠状动脉搭桥术中免接触式与传统静脉桥:多中心随机通畅性试验的三年随访

No-touch versus conventional vein in coronary artery bypass grafting: three year follow-up of multicentre randomised PATENCY trial.

作者信息

Tian Meice, Wang Xianqiang, Feng Wei, Wang Huaibin, Liu Su, Liu Zhigang, Chen Yu, Miao Qi, Su Pixiong, Li Xi, Wang Yang, Lu Bin, Chen Kai, Zhang Changwei, Hu Shengshou

机构信息

Department of Surgery, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

Beijing Hospital, Beijing, China.

出版信息

BMJ. 2025 Apr 30;389:e082883. doi: 10.1136/bmj-2024-082883.

Abstract

OBJECTIVE

To assess the three year outcomes of the no-touch vein harvesting technique in coronary artery bypass grafting surgery compared with the conventional approach.

DESIGN

Three year extended follow-up of the randomised PATENCY (graft patency between the no-touch vein harvesting technique and conventional approach in coronary artery bypass graft surgery) trial.

SETTING

Seven cardiac surgery centres in China; enrolment between April 2017 and June 2019.

PARTICIPANTS

2655 participants aged 18 and older undergoing isolated coronary artery bypass grafting surgery.

INTERVENTIONS

Patients were randomly assigned 1:1 to the no-touch vein harvesting technique group or the conventional approach group during surgery and followed up.

MAIN OUTCOME MEASURES

Vein graft occlusion (based on computed tomography angiography) at three years.

RESULTS

Mean age of participants was 61 years (standard deviation ±8 years) and 22% were women. 99.4% (2621) attended the three year follow-up visit, while 86.5% (2281) received computed tomography angiography. At three years, the no-touch group showed a significantly lower vein graft occlusion rate (5.7% 9.0%, P<0.001) than the conventional group (odds ratio 0.62, 95% confidence interval 0.48 to 0.80), with absolute risk difference of -3.2% (95% confidence interval -5.0% to -1.4%). The intention-to-treat analysis, including all 2655 randomised patients with multiple imputations for missing data, showed consistent findings, with occlusion rates of 6.1% in the no-touch group versus 9.3% in the conventional group (odds ratio 0.63, 95% confidence interval 0.51 to 0.81; absolute risk difference-3.1%, 95% confidence interval -4.9% to -1.4%; P<0.001). These results confirm the robustness of the no-touch technique in reducing vein graft occlusion.

CONCLUSIONS

The no-touch technique consistently and robustly reduced the risk of vein graft occlusion and several cardiac events by one third to one half within three years after coronary artery bypass grafting surgery.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03126409.

摘要

目的

评估冠状动脉搭桥手术中免接触式静脉采集技术与传统方法相比的三年疗效。

设计

对随机分组的PATENCY(冠状动脉搭桥手术中免接触式静脉采集技术与传统方法之间的移植物通畅性)试验进行三年的延长随访。

地点

中国的七个心脏外科中心;2017年4月至2019年6月期间招募患者。

参与者

2655名年龄在18岁及以上接受单纯冠状动脉搭桥手术的参与者。

干预措施

患者在手术期间被随机1:1分配至免接触式静脉采集技术组或传统方法组,并进行随访。

主要观察指标

三年时静脉移植物闭塞情况(基于计算机断层扫描血管造影)。

结果

参与者的平均年龄为61岁(标准差±8岁),女性占22%。99.4%(2621名)参加了三年随访,而86.5%(2281名)接受了计算机断层扫描血管造影。三年时,免接触组的静脉移植物闭塞率(5.7%对9.0%,P<0.001)显著低于传统组(优势比0.62,95%置信区间0.48至0.80),绝对风险差为-3.2%(95%置信区间-5.0%至-1.4%)。意向性分析包括所有2655名随机分组患者,并对缺失数据进行多次插补,结果显示一致,免接触组的闭塞率为6.1%,传统组为9.3%(优势比0.63,95%置信区间0.51至0.81;绝对风险差-3.1%,95%置信区间-4.9%至-1.4%;P<0.001)。这些结果证实了免接触技术在降低静脉移植物闭塞方面的可靠性。

结论

免接触技术在冠状动脉搭桥手术后三年内持续且有力地将静脉移植物闭塞风险及若干心脏事件风险降低了三分之一至二分之一。

试验注册

ClinicalTrials.gov NCT03126409。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82b/12042279/7f11fb851c10/tiam082883.va.jpg

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