Clinical Impact of the Size of Drug-Coated Balloon Therapy on Restenosis Rate in Femoropopliteal Lesions

Abstract

Purpose: Although the size of drug-coated balloons (DCBs) is determined according to the vessel diameter during femoropopliteal (FP)-endovascular therapy (EVT), the measurements of the vessel diameter vary among modalities and its definitions. The aim of this study was to reveal whether the DCB size fitting (1) angiographically-measured lumen diameter (Angio-lumen size), (2) intravascular ultrasound (IVUS)-measured lumen diameter (IVUS-lumen size), or (3) IVUS-measured external elastic membrane (EEM) diameter (IVUS-EEM size) would be beneficial in restenosis occurrence. Materials and Methods: This retrospective, single-center study included 231 de novo FP lesions in 165 patients with peripheral artery disease treated with IN.PACT Admiral DCB under IVUS evaluation. The reference vessel diameter was evaluated as the lumen or EEM diameter at the healthy site distal to the lesion. We retrospectively determined whether the DCB size was close to (ie, equal to or different by <0.5 mm from) Angio-lumen size, IVUS-lumen size, and IVUS-EEM size. The association of the size of DCB with restenosis risk was investigated. Results: The mean lesion length was 13 ± 9 cm and the prevalence of chronic total occlusion was 18%. During a mean follow-up period of 17 ± 9 months, restenosis occurred in 26% of lesions. Lesions treated with a DCB of IVUS-EEM size had a lower 2 year restenosis rate than those treated with a DCB over/under IVUS-EEM size (19.7 ± 5.7% vs 34.5 ± 4.7%, p=0.02 by the log-rank test), while the restenosis rate was not significantly different between DCBs of Angio-lumen size or IVUS-lumen size and those over/under the size (both p>0.05). The multivariate Cox regression analysis revealed that DCBs of IVUS-EEM size were independently associated with a reduced risk of restenosis (adjusted hazard ratio 0.50; 95% confidence interval 0.27–0.95; p=0.03). Conclusion: The DCBs of IVUS-EEM size, but not of Angio-lumen size or IVUS-lumen size, were associated with a reduced risk of restenosis after FP-EVT. Determining the DCB size according to IVUS-evaluated EEM diameter would be potentially beneficial in restenosis occurrence.