| Background:Occlusion of the vein graft is a significant challenge in coronary artery bypass graft(CABG)surgery.The rate of vein graft occlusion can be as high as 50%after 10 years postoperatively.Graft occlusion significantly increases recurrence of angina and the need for repeated myocardial revascularization.Previous studies have demonstrated a reduction of vein graft occlusion with the No-Touch vein harvesting technique,but only with small sample sizes.This trial was aimed to assess whether the No-Touch technique can reduce vein graft occlusion compared with the conventional approach.Methods:The Graft Patency between No-Touch Vein Harvesting Technique and Conventional Approach in Coronary Artery Bypass Graft Surgery Trial(PATENCY)is a multicenter randomized trial with a sample size of 2000 cases.All eligible patients receiving isolated CABG were randomized to receive either the No-Touch vein harvesting technique or the conventional approach.The primary outcome was vein graft occlusion evaluated by CT angiography at 3 months,and the secondary outcomes were 12-month vein graft occlusion by CT angiography,3-month and 12-month major adverse cardiac and cerebrovascular events(MACCE),and 12-month recurrence of angina.Leg wound complications at 3 months and 12 months were evaluated as safety endpoints.The quantitative flow ratios(QFR)of native coronary vessels were also retrospectively performed to assess whether the efficacy of the No-Touch technique could be influenced by coronary hemodynamics.To improve the quality of this technique,we analyzed the risk factors of leg wound complications as the second part of this study.Multivariate analysis was used for analysis of risk factors for leg wound complications.This study was registered at clinicaltrials.gov(NCT03126409).Moreover,we reviewed the mechanism of vein graft failure as well as the research progress of vein graft patency improvement.Results:From April 2017 to June 2019,we randomly assigned 2655 patients undergoing CABG from 7 hospitals in China.The 3-month primary outcome CT angiography was available in 2533 patients,and 2434 at 12 months.Follow-up rate of the primary endpoint was 96.0%.The No-Touch group showed significantly lower rates of vein graft occlusion than the conventional group both at 3-month(2.8%vs.4.8%;odds ratio[OR],0.57;95%confidence interval[CI],0.41-0.80;p<0.001)and 12-month(3.7%vs.6.5%;OR,0.56;95%CI,0.41-0.76;p<0.001)after surgery.At 3-month,significantly more patients in the No-Touch group required surgical intervention for leg wound complication than the conventional group(10.3%vs.4.3%,OR,2.55;95%CI,1.85-3.52;p<0.001).Angina recurrence rate was significantly lower in the No-Touch group at 12 months(2.3%vs.4.1%;hazard ratio(HR),0.55;95%CI,0.35-0.85;p<0.01).Subgroup analysis showed that the No-Touch technique may be more beneficial in smokers and patients with hypertension.The efficacy of the No-Touch technique was not influenced by the quantitative flow ratio(QFR)of the native vessels.Multivariate analysis demonstrated that the risk factors for post-discharge leg wound complications were hypertension(OR=1.77;95%CI:1.14-2.73),diabetes(OR=1.86;95%Cl:1.27-2.72),Postoperative leg wound pain(mild pain(OR=1.82;95%CI:1.232.69),moderate or severe pain(OR=6.29;95%CI:2.45-16.13)),persistent exudation(OR=2.11;95%CI:1.05-4.24)Conclusions:By conducting a large-sample,multicenter randomized clinical trial,we demonstrated that the No-Touch technique significantly reduced vein graft occlusion both at 3 months and 12 months after CABG.There was no significant difference in all cause death or major cardiac and cerebral vascular events at 3-and 12-month followup.Recurrence of angina was significantly lower in the No-Touch group at 12 months postoperatively.Hypertension,diabetes,postoperative leg wound pain and persistent exudation were independent risk factors for leg wound complications of No-Touch vein harvesting in CABG. |
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