To examine clinical outcomes for combination therapy of heparin-bonded covered stent [VIABAHN™ stent (VIA)] and bare-nitinol stent (BNS), and to determine independent predictors of restenosis after VIA implantation assessed by intravascular ultrasound (IVUS). A retrospective analysis was conducted on VIA use in the femoropopliteal artery of 71 patients (81 lesions) treated between June 2012 and November 2018. We divided the treated lesions into two groups; that is, whether BNS was added at the proximal site of the VIA or not (combination of VIA and BNS group [COM; n = 21] vs. VIA group [n = 60]). The median follow-up duration was 21.6 months (interquartile range, 13.2-28.8 months). Restenosis at 2 years was observed in 5 lesions (33%) in COM group and 17 lesions (38%) in VIA group (log-rank, P = 0.74). In VIA group, 14 lesions developed restenosis within 12 months. Multivariate logistic regression analysis of VIA group revealed that the proximal plaque burden was an independent predictor of restenosis within 12 months after VIA implantation (odds ratio 1.15, 95% confidence interval 1.01-1.30, P = 0.01), with the optimal cutoff value of 43% (area under the receiver operator characteristic curve 0.79, sensitivity 91%, specificity 69%). A remaining plaque of > 43% at the proximal reference segment was an independent predictor of restenosis after VIA implantation. When residual stenosis is observed at the proximal site of SFA after VIA implantation, combination therapy of VIA and BNS would be an optimal management.
Keywords: Bare-nitinol stent; Endovascular therapy; Femoropopliteal arterial disease; Heparin-bonded covered stent; Intravascular ultrasound.