A Clinical Trial on No-Touch Vein Graft in Coronary Surgery - SWEDEGRAFT

Aug 31, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Swedish Research Council and Swedish Heart and Lung Foundation
Date Presented:
08/31/2024
Date Published:
08/31/2024
Original Posted Date:
08/31/2024
References

Contribution To Literature:

In patients undergoing isolated nonemergent CABG in the SWEDEGRAFT trial, no-touch SVG harvesting did not result in less graft failure compared with conventional open harvesting at 2 years but increased wound complications.

Description:

The goal of the trial was to determine whether harvesting a saphenous vein graft (SVG) for use in coronary artery bypass grafting (CABG) using a no-touch (NT) technique is associated with improved graft patency compared with conventional open skeletonized (COS) SVG harvesting.

Study Design

  • Registry-based
  • Multicenter
  • Randomized

Patients undergoing isolated CABG with ≥1 SVG were randomized in a 1:1 fashion to undergo intraoperative vein harvesting using the NT or COS technique. In the NT arm, a pedicle SVG was harvested with surrounding tissue via open incision, whereas the COS technique involved open harvest and skeletonization. Manual dilatation and flushing were not permitted with the NT technique.

  • Total number of enrollees: 902
  • Duration of follow-up: Median 3.5 years
  • Mean patient age: 67 years
  • Percentage female: 12%

Inclusion criteria:

  • Age <80 years
  • Isolated, first-time, nonemergent CABG
  • Anticipated need for ≥1 SVG

Exclusion criteria:

  • Prior vein stripping or poor vein quality precluding SVG use
  • Estimated glomerular filtration rate <15 mL/min/1.73 m2
  • Perceived increased risk for wound infection

Other salient features/characteristics:

  • Mean European System for Cardiac Operative Risk Evaluation (EuroSCORE II) score: 1.6
  • Elective CABG: 53%

Principal Findings:

The primary outcome, a composite of ≥50% SVG stenosis on 2-year coronary computed tomography angiography, ≥50% SVG stenosis on coronary angiography, or all-cause death, for NT vs. conventional harvesting at 2 years, was 19.8% vs. 24.0%, difference -4.3% (95% confidence interval [CI] -10.1 to 1.6%, p = 0.15).

Secondary outcomes for NT vs. conventional SVG harvesting:

  • Composite of all-cause death, myocardial infarction, and repeat revascularization at 4.4 years: 12.6% vs. 9.9% (hazard ratio [HR] 1.30, 95% CI 0.87-1.93, p = 0.195)
  • SVG harvest site wound complications at 2 years: 49.6% vs. 25.2%, difference 24.4% (95% CI 17.7-31.1%)

Interpretation:

The principle behind the NT technique for SVG harvest is to limit mechanical distension and trauma by preserving the adventitia and vasa vasorum of the conduit prior to implantation. Early clinical data have been promising with respect to NT graft patency rates but are limited in sample size and generalizability. In fact, it is listed as a Class IIa recommendation in the 2018 ESC/EACTS guidelines on myocardial revascularization.

SWEDEGRAFT is only the second large multicenter trial to compare NT to COS harvesting and demonstrated similar rates of graft failure and major adverse cardiovascular events at 2 years. This contrasts with the Chinese PATENCY trial, which demonstrated better graft patency at 3 and 12 months with the NT technique. It is unclear whether these discordant findings reflect the longer follow-up in the current study or differences in patient population, harvesting technique, or event adjudication. Both trials, however, did demonstrate a higher incidence of wound complications with NT harvesting, which is an important consideration in the face of uncertain benefit compared with a COS approach. Additionally, there are insufficient data to compare the open NT technique with the widespread use of endoscopic SVG harvesting. As presented, these findings do not support the routine use of an NT approach to SVG harvesting in isolated CABG patients.

References:

Presented by Dr. Stefan James at the European Society of Cardiology Congress, London, UK, August 31, 2024.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: Coronary Artery Bypass, Cardiac Surgical Procedures, Tissue and Organ Harvesting, ESC Congress, ESC24


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