Background: Stenosis is a known complication in bypass vein grafts for peripheral arterial disease. The aim of this study was to evaluate the effect of drug-coated balloons (DCBs) in the treatment of vein graft stenoses. DCBs may prevent restenosis in arterial lesions. One small prospective and larger retrospective and registry studies have failed to show benefit from DCBs in vein grafts. Prospective data are scarce.
Methods: Sixty patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to DCB (n = 30) or standard balloon angioplasty (BA) (n = 30). Follow-up was 1 year. The primary outcome measure was target lesion revascularization (TLR). Secondary outcome measures were assisted primary patency and secondary patency and graft occlusion.
Results: Fifty-seven patients were analyzed. Three patients were excluded due to primary technical failure (2 DCB, 1 BA). Overall TLR rate was 34.5% and 46.4% in the DCB and BA groups, respectively (P = 0.33). Five (8.8%) grafts occluded during follow-up (1 DCB, 4 BA). Assisted primary patency was 93.1% (DCB) versus 85.7% (BA) (P = 0.362) and secondary patency was 100% (DCB) versus 89.3% (BA) (P = 0.076). Subgroup analysis showed a significant benefit from DCB in the treatment of primary stenosis (TLR rate 15.0% vs. 18.9%, P = 0.03).
Conclusion: There was no significant benefit from DCBs for treatment of vein graft stenosis compared to BA, although a trend in favor of DCBs could be seen.
Trial registration: ClinicalTrials.govNCT03023098.
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