No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial

Research output: Contribution to journalArticle

Abstract

The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the “no-touch” technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 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. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. 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. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303

Details

Authors
  • Sigurdur Ragnarsson
  • Mikael Janiec
  • Ivy Susanne Modrau
  • Mats Dreifaldt
  • Anders Ericsson
  • Anders Holmgren
  • Henrik Hultkvist
  • Anders Jeppsson
  • Ulrik Sartipy
  • Lisa Ternström
  • M. D. Per Vikholm
  • Domingos de Souza
  • Stefan James
  • Stefan Thelin
Organisations
External organisations
  • Skåne University Hospital
  • Uppsala University Hospital
  • Aarhus University Hospital
  • Örebro University Hospital
  • Blekinge Hospital
  • Norrland University Hospital
  • Linköping University Hospital
  • Sahlgrenska University Hospital
  • Karolinska University Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cardiac and Cardiovascular Systems
Original languageEnglish
Pages (from-to)17-24
Number of pages8
JournalAmerican Heart Journal
Volume224
Publication statusPublished - 2020 Jun
Publication categoryResearch
Peer-reviewedYes