A Clinical Trial on No-touch Vein Graft (NT-graft) in Coronary Surgery

Not Applicable

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Procedure: No touch technique; Procedure: Control technique

• Registration Number: NCT03501303
• Lead Sponsor: Uppsala University

Brief Summary

The primary objective in this study is to investigate if vein grafts harvested and implanted with the non-touch technique are superior to conventional vein graft technique with respect to mid-term patency, in patients undergoing CABG surgery.

Detailed Description

Coronary artery bypass grafting (CABG) is the most common surgical procedure aimed against ischemic heart disease (IHD) in Sweden. Early and late success of CABG is the result of sustained patency of the bypass grafts. The choice of conduit (graft) for CABG has been shown to impact graft patency. The excellent early and late patency of in situ left internal thoracic artery (LITA) has stimulated the use of other arterial grafts, such as the radial artery (RA) and the right internal thoracic artery (RITA). However, target coronary vessels/lesions are limitations for the use of RITA and RA, and concerns regarding postoperative sternal wound infection with increases of early morbidity and mortality are reasons for limited use of bilateral ITA. The saphenous vein grafts (SVG), together with the left internal thoracic artery, are still the most commonly used conduits in CABG surgery.

Vein graft failure is associated with recurrence of angina and one of the primary reasons for reintervention, either by redo CABG or percutaneous coronary intervention (PCI). Early vein graft failure is not uncommon, and it was shown in the PREVENT IV multi-center trial6, that vein graft failure (occluded or stenosed) had occurred in 27% of all vein grafts at one year.

Despite this, SVG remains as an important conduit for most patients in contemporary bypass surgery and every effort should focus on promoting short and long-term patency of SVG. Previous studies by Souza have demonstrated that harvesting the SVG with a pedicle of surrounding tissue and without vein graft distension, the so-called "No touch" technique (NT), significantly improve patency compared with conventional technique i.e. stripping the vein of all adventitial tissue and distension prior to implantation. An international multi center randomized controlled clinical trial, (SUPERIOR SVG, NCT01047449) including 12 centers and 250 patients, was recently presented and showed favorable but not significant results for No touch vein grafts compared to conventional vein grafts. The protocol did not include cardiac computed tomography angiography (CCTA) for every patient which is an important difference compared to our planned study.

The major limitation regarding the putative benefit of NT technique of vein harvesting is that most of the data has all been derived from a single center. The surgical vein graft harvesting technique for NT grafts is more demanding. Therefore, there is a clear clinical equipoise to perform a multi-center randomized clinical trial to validate the excellent single-center results and determine whether the NT technique is reproducible, feasible and generalizable.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-18
• Study Start: 2018-04-20
• Primary Completion: 2023-09-19
• Study Completion: 2023-11-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 902

Inclusion Criteria

• first time CABG patients
• age up to 80 years at the time for inclusion
• need for at least one vein graft
• able to provide informed consent and accepted for isolated primary non-emergent CABG.

Exclusion Criteria

• unable to use greater saphenous vein grafts (SVG) due to previous vein stripping or poor vein quality
• allergy to contrast dye
• renal failure with glomerular filtration rate (GFR)<15 ml/min
• coagulation disorders
• excessive risk of wound infection
• participation in other interventional trial on grafts
• any condition that seriously increases the risk of non-compliance or loss of follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No touch	No touch technique	No touch technique. Patients are randomized to no touch vein harvesting. The technique is used as routine in Medical care by some hospitals.
Control	Control technique	Control technique. Patients are randomized to Control vein harvesting. The technique is used as routine in Medical care.

Primary Outcome Measures

Name	Time	Method
Saphenous vein grafts (SVGs) occluded/stenosed	Follow up period is from inclusion and surgery up to two years after.	The proportion of patients with graft failure defined as: SVGs occluded/stenosed \>50% on CCTA or has undergone percutaneous intervention to a vein graft or died within two years after CABG.

Secondary Outcome Measures

Name	Time	Method
MACE 3	Follow up period is from inclusion and surgery up to two years after.	The frequency of repeated revascularization
Wound complications	Follow up period is from inclusion and surgery up to two years after.	The frequency of incidence of postoperative leg wound complications from the harvesting site.
Major adverse cardiac events (MACE) 1	Follow up period is from inclusion and surgery up to two years after.	The frequency of incidence of all cause death
MACE 2	Follow up period is from inclusion and surgery up to two years after.	The frequency of myocardial infarction
Vein-graft stenosis	Follow up period is from inclusion and surgery up to two years after.	The frequency of non-significant vein graft stenosis (20-50%)

Trial Locations

Locations (9)

Göteborg; 🇸🇪 Göteborg, Sweden

Karlskrona; 🇸🇪 Karlskrona, Sweden

Lund; 🇸🇪 Lund, Sweden

Aarhus; 🇩🇰 Aarhus, Denmark

Linköping; 🇸🇪 Linköping, Sweden

Karolinska Sjukhuset; 🇸🇪 Stockholm, Sweden

Uppsala; 🇸🇪 Uppsala, Sweden

Örebro, Sweden; 🇸🇪 Örebro, Sweden

Umeå; 🇸🇪 Umeå, Sweden