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No-Touch Versus Conventional Saphenous Vein Harvesting Technique

Not Applicable
Active, not recruiting
Conditions
Coronary Artery Disease
Interventions
Procedure: Conventional vein harvesting
Procedure: No-Touch vein harvesting technique
Registration Number
NCT03126409
Lead Sponsor
China National Center for Cardiovascular Diseases
Brief Summary

This study evaluates the short-term patency of vein graft harvested by the No-Touch technique compared to that by the conventional approach in patients undergoing isolated on-pump/off-pump coronary artery bypass graft (CABG) surgery. a total of at least 2000 patients undergoing isolated on-pump/off-pump CABG will be consecutively recruited from 7 hospitals across China and randomly assigned to receive No-Touch saphenous vein harvesting or conventional approach. All participants will be invited for clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis at 3 months post-operatively.

Detailed Description

CABG is still the treatment of choice for ischemic heart disease. However, restenosis or occlusion may occur to graft vessels, leading to postoperative myocardial ischemia and subsequent clinical events. Long-term angiographic follow-up demonstrated that vein graft restenosis and occlusion are common among those receiving CABG, with a vein graft patency of less than 50% at 15 years postoperatively. Besides, it is found that graft occlusion may occur as early as 3 months after the surgery. It is, therefore, a major priority to improve the short-term postoperative vein graft patency so as to achieve better prognosis for patients.

Saphenous vein, the currently most frequently used graft material, occupies over 70% of all graft vessels.

Multiple factors may contribute to the early restenosis or occlusion of the vein grafts, including anastomosis technique, graft vessel quality, target lesion site and degree of stenosis, perioperative coagulating function, etc. The No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension. This technique has been reported associated with better short and long-term vein graft patency. However, these results mostly came from small-scale, single-center studies, therefore could hardly be recognized as high-level evidence for generalization of the technique.

This prospective multi-center study aims to compare the short-term saphenous vein graft patency harvested by the No-Touch technique and the conventional approach. This study will consecutively enroll 2000 patients undergoing isolated on-pump/off-pump CABG in 7 hospitals of China. After obtaining informed written consent, participants will be randomly allocated to either the No-Touch harvesting or conventional approach group. At baseline, participants will be interviewed to collect detailed information about on demographics, socioeconomic status, cardiovascular risk factors, clinical characteristics, treatments, in-hospital outcomes, general and disease-specific quality of life, function and mental status. During the follow-ups, the investigators will collect information about clinical outcomes events, long-term treatments, function, quality of life, symptoms, and medical care during the recovery period. All participants will be invited for 64-slice multi-slice computed tomography angiography (MSCTA) analysis at 3 months post-operatively for graft patency evaluation.

The patients, data adjudicators and CT reviewers will be blinded to the study. Due to the nature of this study, the operating surgeons, anesthetists and other operative room staff will not be blind in this study.

By comparing the short-term graft patency between the No-Touch and conventional vein harvesting groups, this study will contribute major evidence of the possible superiority of this technique, so as to improve patient outcomes after CABG surgery.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
2655
Inclusion Criteria
  • Patients receiving first time isolated on-pump/off-pump CABG
  • Patients with at least one available saphenous vein graft
Exclusion Criteria
  • Need for a concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
  • Redo-CABG
  • Emergent CABG
  • Using vascular stapler for anastomosis
  • Endarterectomy of coronary artery during surgery
  • Left ventricular repair due to ventricular aneurysm
  • Combined with malignant tumor or other severe systemic conditions
  • Severe renal insufficiency (i.e. creatinine >200 μmol/L)
  • Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
  • Participants of another ongoing clinical trials

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conventional vein harvestingConventional vein harvestingDuring saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed
No-Touch vein harvesting techniqueNo-Touch vein harvesting techniqueDuring saphenous vein harvesting, surrounding tissue of the vein is preserved, and manual distension of the vein graft is avoided
Primary Outcome Measures
NameTimeMethod
Prevalence of graft occlusion3 month after procedure

All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.

Secondary Outcome Measures
NameTimeMethod
Prevalence of graft occlusion1, 3, 5, 7, and 10 years after procedure

All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.

Overall major adverse cardiac or cerebrovascular events (MACCE) rate3 month , 1, 3, 5, 7, and 10 years after procedure

MACCE includes death, myocardial infarction, stroke and/or repeat revascularization

Cardiac death3 month , 1, 3, 5, 7, and 10 years after procedure

death from any heart disease

Documented non-lethal myocardial infarction3 month , 1, 3, 5, 7, and 10 years after procedure

Myocardial infarction is defined according to the most recent guideline

Stroke3 month , 1, 3, 5, 7, and 10 years after procedure

an acute symptomatic episode of focal or global neurological dysfunction caused by brain, spinal, or retinal vascular injury as a result of hemorrhage or infarction

Target lesion revascularization3 month , 1, 3, 5, 7, and 10 years after procedure

CABG or percutaneous coronary intervention

Recurrence of Angina3 month, 1, 3, 5, 7, and 10 years after procedure

recurrence of unstable angina

Rehospitalization due to cardiac reason3, 5, 7, and 10 years after procedure

Rehospitalization due to cardiac reason

Trial Locations

Locations (1)

Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases

🇨🇳

Beijing, Beijing, China

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