Abstract
Importance
No-touch saphenous vein harvesting preserves perivascular tissue and may improve graft patency after coronary artery bypass grafting (CABG), but whether it reduces long-term clinical events remains uncertain.
Objective
To compare 7-year clinical outcomes after no-touch vs conventional saphenous vein harvesting in patients undergoing CABG.
Design, Setting, and Participants
This is a prespecified extended follow-up of the SWEDEGRAFT multicenter, binational, randomized clinical trial, which was conducted at 8 cardiac surgery centers in Sweden and 1 center in Denmark. Patients undergoing primary, nonemergent, isolated CABG were eligible for inclusion. The study was conducted between April 20, 2018, and June 3, 2020, and data were analyzed from February 2026 to April 2026.
Intervention
Patients were randomized 1:1 to no-touch or conventional saphenous vein harvesting.
Main Outcomes and Measures
The primary outcome was a composite of death from any cause, myocardial infarction, or repeat revascularization. Secondary outcomes were the individual components of the primary composite. Outcomes were ascertained through national population-based registries.
Results
A total of 902 patients undergoing primary, nonemergent, isolated CABG were randomized; 900 were included in the modified intention-to-treat population. Among 900 patients, 454 were assigned to no-touch harvesting and 446 to conventional harvesting. Mean (SD) age was 67.0 (7.6) years, 108 patients (12.0%) were women, and 419 patients (46.6%) underwent nonelective surgery. Median (IQR) follow-up was 6.46 (5.92-6.86) years. The primary outcome occurred in 90 patients in the no-touch group and 91 patients in the conventional group (19.8% vs 20.4%; hazard ratio [HR], 0.98; 95% CI, 0.73-1.31;
P
= .90). The adjusted 7-year risk difference was −0.8% (95% CI, −6.6% to 4.6%). The secondary outcomes did not differ significantly between groups: death (HR, 0.84; 95% CI, 0.53-1.35), myocardial infarction (HR, 0.74; 95% CI, 0.44-1.24), and repeat revascularization (HR, 1.07; 95% CI, 0.73-1.56). Prespecified subgroup analyses showed no heterogeneity in treatment effect.
Conclusions and Relevance
In this 7-year follow-up of the SWEDEGRAFT randomized clinical trial, no-touch saphenous vein harvesting was not shown to significantly reduce the composite of death from any cause, myocardial infarction, or repeat revascularization through 7 years of follow-up. Taken together with the previously reported excess of leg wound complications, these findings do not establish a net clinical benefit of routine no-touch harvesting.
Trial Registration
ClinicalTrials.gov Identifier:
NCT03501303