Silver acetate and Triclosan Antimicrobial Graft Evaluation for surgical Repair of aortic disease (STAGER Study).

Abstract

Background: The aim of this study was to assess perioperative and late performance of a silver acetate and triclosan impregnated antimicrobial vascular graft (Intergard Synergy, Intervascular SAS, La Ciotat, France) during open surgical repair of abdominal aortic aneurysms (AAA), and to compare it with standard polyester grafts ones.

Methods: This retrospective single-centre study (STAGER Study, clinicaltrials.gov: NCT04557254) included patients undergone non-infectious AAA surgical repair between 2012 and 2019, divided into two groups according to the implanted aortic prosthesis: standard polyester graft (PolyG) and silver-triclosan graft (SynG). Early primary endpoints were 30-day mortality, major adverse events (MAEs), and reintervention rates; late primary endpoints were overall and aortic-related survival, reintervention-free survival, and graft infection rate at a mean follow-up (FU) of 49.4±26.8 months.

Results: Five hundred forty-seven patients were included [PolyG 49%, and SynG 51%]. Both groups were substantially homogeneous in risk factors and demographics. Two patients died within 30 days. In-hospital MAE rate [PolyG 14.2% vs. SynG 10.7%; P=.248] and 30-day reintervention rate were not significantly different [PolyG 2.6% vs. SynG 1.4%; P=.374]. At 5 years, overall survival in the PolyG and SynG groups were 85% and 84%, respectively. Reintervention-free survival was 82% for both groups. Aortic-related survival was 95% and 96%, respectively. Graft infection was observed in 8 (3.3%) PolyG patients and 5 (1.8%) SynG patients.

Conclusions: Silver acetate and triclosan impregnated grafts demonstrated good early and mid-term results, being considered safe and durable for AAA open repair. Similar graft infection and related death rates were observed compared to polyester standard grafts, supporting non-superiority of one graft over the other.