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

Ragnarsson, Sigurdur LU ; Janiec, Mikael ; Modrau, Ivy Susanne ; Dreifaldt, Mats ; Ericsson, Anders ; Holmgren, Anders ; Hultkvist, Henrik ; Jeppsson, Anders ; Sartipy, Ulrik and Ternström, Lisa , et al. (2020) In American Heart Journal 224. p.17-24
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... (More)

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

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publication status
published
subject
in
American Heart Journal
volume
224
pages
8 pages
publisher
Mosby-Elsevier
external identifiers
  • scopus:85082662443
  • pmid:32272256
ISSN
0002-8703
DOI
10.1016/j.ahj.2020.03.009
language
English
LU publication?
yes
id
e6ea4c09-b845-441a-b936-297cf69098f6
date added to LUP
2020-04-15 17:08:33
date last changed
2024-10-03 00:15:26
@article{e6ea4c09-b845-441a-b936-297cf69098f6,
  abstract     = {{<p>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 &gt;50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed &gt;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</p>}},
  author       = {{Ragnarsson, Sigurdur and Janiec, Mikael and Modrau, Ivy Susanne and Dreifaldt, Mats and Ericsson, Anders and Holmgren, Anders and Hultkvist, Henrik and Jeppsson, Anders and Sartipy, Ulrik and Ternström, Lisa and Per Vikholm, M. D. and de Souza, Domingos and James, Stefan and Thelin, Stefan}},
  issn         = {{0002-8703}},
  language     = {{eng}},
  pages        = {{17--24}},
  publisher    = {{Mosby-Elsevier}},
  series       = {{American Heart Journal}},
  title        = {{No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT) : Rationale and design of a multicenter, prospective, registry-based randomized clinical trial}},
  url          = {{http://dx.doi.org/10.1016/j.ahj.2020.03.009}},
  doi          = {{10.1016/j.ahj.2020.03.009}},
  volume       = {{224}},
  year         = {{2020}},
}