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

Methods

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.

对随机对照的PATENCY试验（冠状动脉旁路移植术中无接触静脉剥脱技术与传统方法的移植血管通畅性）进行了三年的延长随访。

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

在中国的七家心脏外科中心；招募时间为2017年4月至2019年6月。

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

2655名年龄在18岁及以上的参与者接受了孤立的冠状动脉旁路移植手术。

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

患者在手术中按1:1的比例随机分配到无接触静脉获取技术组或传统方法组，并进行了随访。

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

三年时通过计算机断层扫描血管造影确定的静脉移植物闭塞情况。

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.

参与者的平均年龄为61岁（标准差±8岁），其中22%为女性。99.4%（2621人）参加了三年随访，86.5%（2281人）接受了计算机断层扫描血管造影。

At three years, the no-touch group showed a significantly lower vein graft occlusion rate (5.7% v 9.0%, P<0.001) than the conventional group (odds ratio 0.62, 95% confidence interval0.48 to 0.80), with absolute risk difference of -3.2% (95% confidence interval-5.0% to -1.4%).

在三年时，无接触组的静脉移植物闭塞率显著低于常规组（5.7%对比9.0%，P<0.001），绝对风险差异为-3.2%（95%置信区间-5.0%至-1.4%），比值比为0.62（95%置信区间0.48至0.80）。

The intention-to-treatanalysis, 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 interval0.51 to 0.81; absolute risk difference-3.1%, 95% confidence interval-4.9% to -1.4%; P<0.001).

意向性治疗分析，包括所有2655名随机患者，对缺失数据进行了多重插补，显示了一致的结果，无接触组的闭塞率为6.1%，而传统组为9.3%（比值比0.63，95%置信区间0.51至0.81；绝对风险差异-3.1%，95%置信区间-4.9%至-1.4%；P<0.001）。

These results confirm the robustness of the no-touch technique in reducing vein graft occlusion.

这些结果证实了无接触技术在减少静脉移植物闭塞方面的稳健性。

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.

无接触技术在冠状动脉旁路移植术后三年内，一致且显著地将静脉移植物闭塞风险以及多种心脏事件的风险降低了三分之一到一半。

trial_registration

ClinicalTrials.gov NCT03126409.

ClinicalTrials.gov NCT03126409。