Percutaneous transluminal angioplasty with drug-eluting balloons for salvage of infrainguinal bypass grafts.

Purpose: To evaluate the safety and feasibility of using drug-eluting balloons (DEBs) in the treatment of infrainguinal bypass graft stenoses.

Methods: A nonrandomized prospective study evaluated the feasibility of DEB treatment for intragraft/anastomotic stenoses arising >1 month after infrainguinal bypass grafting; stenoses due to graft/technical problems (e.g., vein torsion) were excluded, as were failed grafts that could not be successfully recanalized with catheter-directed thrombolysis. Between February 2010 and February 2012, 41 patients (35 men; mean age 71 years, range 46-87) were treated with DEBs for 63 anastomotic/intragraft stenoses in vein or prosthetic grafts. Follow-up was performed with duplex ultrasonography. The primary endpoint at 12 months was graft occlusion or >50% restenosis at the DEB treatment site.

Results: DEB treatment was technically successful in 61 (96.8%) of the 63 lesions with no complications other than one instance of vasospasm; one totally occluded segment and one restenosis were treated surgically. The mean follow-up was 16.7 months (range 3-24). The estimated cumulative target site primary and secondary patency rates at 6 months were 91% and 96%, respectively, and 70% and 90%, respectively, at both 12 and 18 months (no restenoses after 12 months). The estimated mean durations of primary and secondary treatment site patency were 20.3 and 22.7 months, respectively (p=0.033). At 6 and 12/18 months, the cumulative rates were 96% and 90%, respectively, for graft patency and 98% and 93% for freedom from amputation.

Conclusion: DEBs proved to be a feasible, safe, and effective treatment for vein and prosthetic bypass graft stenoses, with excellent technical success and acceptable short and midterm patency.