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

Study design

Multicentre, binational, prospective, randomized, open, blinded end-point, randomized, register-based, clinical trial.

About the project

Patients undergoing first isolated nonemergent CABG were randomized 1:1 to no-touch or conventional open skeletonized saphenous vein graft harvesting technique. 902 patients were included from March 2018 until May 2020 in all eight Swedish centres and Aarhus University Hospital (265 patients).

The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years.

The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data.

Objective(s)

  • To assess if the no-touch technique of saphenous vein graft harvesting in coronary artery bypass grafting (CABG) patients will reduce vein graft failure and improve clinical outcome after 2 years.
  • To compare the incidence of leg graft wound complications following no-touch and conventional saphenous vein graft harvest.

Project group

  • Stefan Thelin (Sponsor), Uppsala University Hospital, Uppsala, Sweden
  • Ivy Susanne Modrau, Aarhus University Hospital, Aarhus, Denmark
  • Sigurdur Ragnarsson, Skåne University Hospital and Lund University, Lund, Sweden
  • Mats Dreifaldt, Örebro University Hospital, Örebro, Sweden
  • Anders Ericsson, Blekinge Hospital, Karlskrona, Sweden
  • Anders Holmgren, University Hospital of Umea, Umea, Sweden
  • Henrik Hultkvist, Linköping University Hospital, Linköping, Sweden
  • Anders Jeppsson, Sahlgrenska University Hospital, Gothenburg, Sweden
  • Per Vikholm, Karolinska University Hospital, Stockholm, Sweden

Funding

The Swedish Research Council (Vetenskapsrådet) and the Swedish Heart and Lung Foundation (Hjärt-Lungfonden).

Published papers

  • Ragnarsson, S., Janiec, M., Modrau, I. S., Dreifaldt, M., Ericsson, A., Holmgren, A. Hultkvist, H., Jeppsson, A., Sartipy, U. Ternström, L., Vikholm, P., Souza, D., James, S., Thelin, S. (2019). No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. American Heart Journal. DOI: 10.1016/j.ahj.2020.03.009

Status

Follow-up

Project period

Start: 1 March 2018
End: 1 December 2023

Contact

Principal Investigator