Relationship between intra-operative vein graft treatment with DuraGraft® or saline and clinical outcomes after coronary artery bypass grafting

ABSTRACT

Background: Saphenous vein grafts (SVGs) remain the most often used conduits for coronary bypass grafting (CABG). Progressive intimal hyperplasia contributes to vein-graft disease and vein-graft failure (VGF). We compared the impact of intraoperative preservation of SVGs in a storage solution (DuraGraft®) versus heparinized saline on VGF-related outcomes after CABG.

Methods: From 1996 to 2004, 2436 patients underwent isolated CABG with ≥ 1 SVG. SVGs were consecutively treated with DuraGraft in 1036 patients (2001−2004) and heparinized saline in 1400 patients (1996−1999). Short- (< 30 days) and long-term (≥ 1000 days) outcomes were assessed using repeat revascularization (primary end point), and major adverse cardiac events (MACE) consisting of the composite of death, nonfatal myocardial infarction, or repeat revascularization.

Results: Mean follow-up in the DuraGraft group was 8.5 ± 4.2 years and 9.9 ± 5.6 years in controls. Short-term event rates were low and generally did not differ between groups. DuraGraft was associated with a 45% lower occurrence of nonfatal myocardial infarction after 1000 days (hazard ratio 0.55, 95% CI 0.41−0.74; P < 0.0001). There was 35% and 19% lower long-term risk for revascularization (HR 0.65, 95% CI 0.44−0.97; P = 0.037) and MACE (HR 0.81, 95% CI 0.70−0.94; P = 0.0051), respectively, after DuraGraft. Mortality was comparable between both groups at 1, 5, and 10 years. There was no statistically significant association between DuraGraft exposure and time to death starting at 30 or 1000 days (HR 0.91, 95% CI 0.76−1.09; P = 0.29).

Conclusion: In this study, intraoperative treatment of SVGs with DuraGraft was associated with a lower risk of long-term adverse events suggesting that efficient intraoperative SVG treatment may reduce VGF-related complications post-CABG. These data warrant randomized clinical trials to validate these findings.

KEYWORDS:

• CABG
• myocardial infarction
• patency
• repeat revascularization
• vein graft failure

Author contributions

Conception and design of research: M Haime, MJ Gaziano, K Cho, DR Gagnon

Data analysis and study design: M Haime, MJ Gaziano, K Cho, DR Gagnon, RR McLean, KE Kurgansky, MY Emmert, N Kosik, C Nelson, DR Gagnon

Initial article write-up: M Haime, MY Emmert, RR McLean, DR Gagnon

Critical revision of article: M Haime, MY Emmert, RR McLean, DR Gagnon

Approval of article: M Haime, MJ Gaziano, K Cho, DR Gagnon, RR McLean. KE Kurgansky, MY Emmert, N Kosik, C Nelson, DR Gagnon

Statistics: RR McLean, KE Kurgansky, N Kosik, C Nelson, MJ Gaziano, K Cho, DR Gagnon

Declaration of interest

MY Emmert is a consultant to Somahlution Inc., Jupiter, FL, USA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

The data analysis for this study was supported by an unrestricted grant to BVARI (Boston VA Research Institute) by Somahlution Inc. FL, USA.