Proximal Versus Distal Segments of No-Touch Saphenous Vein Grafts

Major Leg Wound Complications Between the Proximal and Distal Segments of Saphenous Veins Harvested by No-Touch Technique in Coronary Artery Bypass Graft Surgery: a Single-center Randomized Within-subject Controlled Clinical Trial

The optimum segment of No-Touch veins for bypassing is still undefined. The purpose of this study is to assess the incidence of leg wound complication after No-Touch harvesting of proximal segment of saphenous veins compared to distal segment of veins in the leg. Graft occlusion rates between the two segments of veins for bypassing will also be compared during follow-up.

Study Overview

• Status: Unknown
• Conditions: Leg Wound Complication After No-Touch Harvestingof Veins
• Intervention / Treatment: Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique

Detailed Description

This is a prospective, single-center, open-label, randomized within-subject-controlled trial. We aim to randomize 100 patients undergoing isolated coronary artery bypass graft (CABG). We consecutively screen patients during the study enrollment period and seek informed consent from all eligible patients. In each patient, one saphenous vein graft (SVG) will be randomized to be the proximal segment, while another will be the distal segment as control. Healing of leg wounds will be assessed on day 6 post-operatively. Follow-up will be performed via face-to-face interview until at least 1 year after the operation by CT angiography.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
      • Contact: Meice Tian, M.D.; Phone Number: +8613718863077; Email: tianmeice@fuwaihospital.org
      • Sub-Investigator: Shengshou Hu, M.D.
      • Sub-Investigator: Xianqiang Wang, M.D.
      • Principal Investigator: Meice Tian, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18 or older who undergo primary isolated open-chest CABG with two vein grafts, one to the left coronary territory and the other to the right, with or without cardiopulmonary bypass

Exclusion Criteria:

• Concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
• Redo CABG
• Emergent CABG (cardiogenic shock, inotropic pressure support, IABP)
• Severe vein varicosity as assessed after vein harvesting and before randomization
• Use of vascular stapler for anastomosis
• Endarterectomy of coronary artery during surgery
• Left ventricular repair due to ventricular aneurysm
• Concomitant life-threatening disease likely to limit life expectancy to less than two years
• Severe renal insufficiency (i.e. creatinine >200 μmol/L)
• Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
• Participant of other ongoing clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proximal group; Proximal segment of saphenous veins are harvested from the thigh by No-Touch technique and randomized to bypass the left or right territory of coronary system	Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique; two longitudinal incisions are made on the thigh and shank from unilateral lower limb (for harvesting of proximal segment of saphenous vein, incision is started from about 3 or 4cms inferolateral to the pubic tubercle and then extended downward). As previous reported. the adventitia and perivascular tissue are carefully kept intact to avoid damage. Then a margin of about 5 mm from both sides of the vein is created to include the fat pedicle using electrocautery, and all visible side branches are ligated with 4-0 silk or by metal clipping (branches are divided at the pedicle margin rather than the vein trunk). The saphenous vein is then separated from its bed using scissors and electrocautery, together with surrounding tissue.
Active Comparator: Distal group; Distal segment of saphenous veins are harvested from the shank of the ipsilateral leg by No-Touch technique and used to bypass the right or left territory of coronary system (depending on the randomizing result of the proximal segments)	Procedure: Proximal and distal segment of saphenous vein harvested by No-Touch technique; two longitudinal incisions are made on the thigh and shank from unilateral lower limb (for harvesting of proximal segment of saphenous vein, incision is started from about 3 or 4cms inferolateral to the pubic tubercle and then extended downward). As previous reported. the adventitia and perivascular tissue are carefully kept intact to avoid damage. Then a margin of about 5 mm from both sides of the vein is created to include the fat pedicle using electrocautery, and all visible side branches are ligated with 4-0 silk or by metal clipping (branches are divided at the pedicle margin rather than the vein trunk). The saphenous vein is then separated from its bed using scissors and electrocautery, together with surrounding tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major leg wound complication at 6 days postoperatively	a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure	6 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major leg wound complication during 3-month follow-up	a leg wound that had failed to respond to conservative treatment and required subsequent surgical intervention such as debridement, re-suture, delayed wound closure	3 month
Graft vessel occlusion at 3 month and 1 year	Graft occlusion is detected by multislice computed tomography angiography (MSCTA). Graft assessment is conducted according to the FitzGibbon criteria. Each graft is graded as A (excellent), B (fair), or O (occluded). Contrast filling of the grafts, anastomoses, and coronary arteries beyond the graft are considered in each assessment. Grade A indicates that the graft is patent with ≤50% stenosis. Grade B indicates that graft stenosis is >50% but not occluded. When a conduit does not fill with contrast at all, it is considered Grade O and included with string sign found in any segment (including proximal anastomotic site, distal anastomotic site, and main trunk). Both of these latter findings are considered together and referred to as occlusion in the analysis.	3 months and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac or cerebrovascular events (MACCE)	including cardiovascular death, non-fatal myocardial infarction (MI), stroke and target vessel revascularization	3 months and 1 year
Individual MACCE	including cardiovascular death, non-fatal myocardial infarction, stroke and target vessel revascularization	3 months and 1 year
Recurrence of angina	Events that fulfill the following definition are to be coded as Angina: i. ischemic chest pain or equivalent (e.g. arm, neck or jaw pain or discomfort thought to be related to cardiac ischemia); and ii. no evidence of MI; and iii. no clear alternative (non-cardiac) explanation (e.g. anemia, arrhythmia)	3 months and 1 year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: coronary artery bypass graft; leg wound complication; No-Touch saphenous vein harvesting technique
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2019-F06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No