Drug-Eluting Stents are Associated with Superior Mid-Term Outcomes for the Treatment of Infrainguinal Bypass Graft Stenoses.

Background: We previously demonstrated that everolimus drug-eluting stents (eDES) have reasonable short-term patency for the treatment of infrainguinal bypass stenoses. The aim of this study is to compare mid-term outcomes of eDES, plain balloon angioplasty (PTA), percutaneous cutting balloon (PCB), and drug-coated balloon (DCB) interventions for failing infrainguinal bypasses.

Methods: We conducted a retrospective review of patients with infrainguinal bypass stenoses treated by endovascular intervention (August 2010-August 2021). The primary outcome was primary patency (PP). Secondary outcomes were primary-assisted patency (PAP), secondary patency (SP), limb salvage (LS), and mortality. Outcomes were compared by treatment using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models adjusting for baseline differences between groups.

Results: Seventy-two consecutive patients with 152 discrete infrainguinal bypass graft stenoses were identified. Mean age was 65.1 ± 10.6 years, 55.6% were male, and 48.6% were Black. In total, 81.9% of patients were originally treated for chronic limb-threatening ischemia, and 57.2% of distal anastomoses were to tibial or pedal targets. Of 152 lesions, 44.1% (n = 67) were treated with PTA, 17.8% (n = 27) with PCB, 20.4% (n = 31) with DCB, and 17.8% (n = 27) with eDES. Median follow-up was 28.5 months (interquartile range 11.5-51.9). There was no difference in bypass configuration, conduit choice, or stenosis location (proximal anastomosis, mid-bypass, distal anastomosis) between groups. At 24 months postintervention, PP was significantly better for eDES (72.9%, 95% confidence interval [CI] 49.8-85.6), followed by PCB (55.9%, 95% CI 34.2-72.9), PTA (34.4%, 95% CI 21.7-47.4), and DCB (33.6%, 95% CI 14.5-53.9) (P = 0.03). PAP, LS, and mortality did not significantly differ between modalities (P > 0.05). After risk adjustment, eDES was associated with the lowest risk of PP loss (hazard ratio versus PTA 0.15, 95% CI 0.05-0.47).

Conclusions: eDES is associated with superior 24-month patency rates compared to other endovascular technologies, and should be considered a primary therapy modality for the treatment of infrainguinal bypass graft stenoses.