Seven-year follow-up data from the SWEDEGRAFT trial, testing the ‘no-touch’ technique for graft harvesting for coronary artery bypass graft (CABG) surgery, do not establish a net clinical benefit for the routine use of the technique, investigators say.
No-touch harvesting, which was developed in Sweden, is an atraumatic approach to remove the saphenous vein complete with its cushion of surrounding tissue without touching the vessel at all, unlike traditional vein harvesting where all of the tissue is stripped from the vein.
SWEDEGRAFT is a multicentre, registry-based, randomised trial conducted at eight cardiac surgery centres in Sweden and one in Denmark, comparing clinical outcomes of no-touch versus conventional vein harvesting. A total of 902 patients were enrolled in the trial, with a mean age of 67 years and 88% of whom were male.
Initial results of the study were presented at the European Society of Cardiology (ESC) congress in 2024 (30 August–2 September; London, UK), where the study’s lead investigator, Stefan James (Uppsala University Hospital, Uppsala, Sweden), reported that the technique had failed to show superiority over the traditional vein harvesting technique. An excess of leg wound complications among patients randomised to the no-touch technique also raised safety concerns associated with the technique.
Reporting long-term clinical outcomes of the trial in a publication this week in JAMA Cardiology, Magnus Dalén (Karolinska University Hospital Stockholm, Stockholm, Sweden) and colleagues detail that at seven years, the composite primary outcome of all-cause death, myocardial infarction (MI) or repeat revascularisation occurred in 90 patients in the no-touch group and 91 patients in the conventional group (19.8% vs. 20.4%), representing an adjusted seven-year risk difference of −0.8%.
“Of the three components of the composite outcome, MI is the endpoint most plausibly related to graft status. MI occurred in 25 patients (5.5%) in the no-touch group and 33 patients (7.4%) in the conventional group, and the restricted mean survival time difference at seven years was 25.5 days,” Dalén and colleagues write.
The increased risk of leg wound morbidity is, the investigators state, consistent with earlier evidence and must be weighed against the absence of demonstrated long-term clinical benefit.
The study team notes some limitations to the trial, including that it was powered for a graft-level endpoint rather than clinical outcomes.
