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


      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.


      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.


      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).


      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.
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        • Avino A.J.
        • Bandyk D.F.
        • Gonsalves A.J.
        • et al.
        Surgical and endovascular intervention for infrainguinal vein graft stenosis.
        J Vasc Surg. 1999; 29: 60-70
        • Garvin R.
        • Reifsnyder T.
        Cutting balloon angioplasty of autogenous infrainguinal bypasses: short-term safety and efficacy.
        J Vasc Surg. 2007; 46: 724-730
        • Schneider P.A.
        • Caps M.T.
        • Nelken N.
        Infrainguinal vein graft stenosis: cutting balloon angioplasty as the first-line treatment of choice.
        J Vasc Surg. 2008; 47: 960-966
        • Jongsma H.
        • Akkersdijk G.P.
        • de Smet A.
        • et al.
        Drug-eluting balloons and uncoated balloons perform equally to rescue infrainguinal autologous bypasses at risk.
        J Vasc Surg. 2017; 66: 454-460
        • Kitrou P.
        • Parthipun A.
        • Diamantopoulos A.
        • et al.
        Paclitaxel-coated balloons for failing peripheral bypass grafts: the BYPACS study.
        J Cardiovasc Surg (Torino). 2014; 55: 217-224
        • Linni K.
        • Ugurluoglu A.
        • Aspalter M.
        • et al.
        Paclitaxel-coated versus plain balloon angioplasty in the treatment of infrainguinal vein bypass stenosis.
        J Vasc Surg. 2016; 63: 391-398
        • San Norberto E.M.
        • Taylor J.H.
        • Carrera S.
        • et al.
        Percutaneous transluminal angioplasty with drug-eluting balloons for salvage of infrainguinal bypass grafts.
        J Endovasc Ther. 2014; 21: 12-21
        • Airoldi F.
        • Baldino G.
        • Mortola P.
        • et al.
        Nitinol stents with polymer-free paclitaxel coating for stenosis of failing infrainguinal bypass grafts.
        J Cardiovasc Surg (Torino). 2013; 54: 441-445
        • Hicks C.W.
        • Canner J.K.
        • Lum Y.W.
        • et al.
        Drug-eluting stents are associated with improved outcomes for the treatment of infrainguinal bypass graft stenoses.
        J Vasc Surg. 2019; 69: 875-882
        • Rutherford R.B.
        • Baker J.D.
        • Ernst C.
        • et al.
        Recommended standards for reports dealing with lower extremity ischemia: revised version.
        J Vasc Surg. 1997; 26: 517-538
        • Carlson G.A.
        • Hoballah J.J.
        • Sharp W.J.
        • et al.
        Balloon angioplasty as a treatment of failing infrainguinal autologous vein bypass grafts.
        J Vasc Surg. 2004; 39: 421-426
        • Berceli S.A.
        Revision of vein bypass grafts: factors affecting durability of interventions.
        Semin Vasc Surg. 2009; 22: 261-266
        • Kimura T.
        • Morimoto T.
        • Natsuaki M.
        • et al.
        Comparison of everolimus-eluting and sirolimus-eluting coronary stents: 1-year outcomes from the Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET).
        Circulation. 2012; 126: 1225-1236
        • Schomig A.
        • Dibra A.
        • Windecker S.
        • et al.
        A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease.
        J Am Coll Cardiol. 2007; 50: 1373-1380
        • Stone G.W.
        • Midei M.
        • Newman W.
        • et al.
        Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial.
        Circulation. 2009; 119: 680-686
        • Axel D.I.
        • Kunert W.
        • Goggelmann C.
        • et al.
        Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery.
        Circulation. 1997; 96: 636-645
        • Martinet W.
        • De Loof H.
        • De Meyer G.R.Y.
        mTOR inhibition: a promising strategy for stabilization of atherosclerotic plaques.
        Atherosclerosis. 2014; 233: 601-607
        • Wessely R.
        • Schomig A.
        • Kastrati A.
        Sirolimus and Paclitaxel on polymer-based drug-eluting stents: similar but different.
        J Am Coll Cardiol. 2006; 47: 708-714
        • Katsanos K.
        • Spiliopoulos S.
        • Kitrou P.
        • et al.
        Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials.
        J Am Heart Assoc. 2018; 7: e011245
        • Bertges D.J.
        • Eldrup-Jorgensen J.
        • Robbins S.
        • et al.
        Vascular quality initiative surveillance of femoropopliteal artery paclitaxel devices.
        JACC Cardiovasc Interv. 2021; 14: 2598-2609