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.

Impact of Postoperative Lumen Gain on the Reduction of Restenosis Risk after Endovascular Treatment using Drug-coated Balloon for Femoropopliteal Lesions Assessed by Intravascular Ultrasound

“…Few large-scale studies have investigated whether postprocedural findings could be associated with restenosis risk after DCB treatment. The restenosis after DCB treatment has been reportedly affected by various factors, including vessel diameter, CTO, and severe calcification [13][14][15] . The MLA was expected to be highly dependent on baseline characteristics, and the present study successfully addressed those confounding influences by using the GPS method.…”

“…Allan et al conducted an RCT and showed that the use of IVUS results in larger vessel diameter and significant reduction in the restenosis rate 1 year after DCB treatment (9.1% vs. 37.5%, p=0.001) 20) . Furthermore, in a retrospective study, Kurata et al suggested that larger DCB sizes are selected based on EEM diameter than based on lumen diameter (5.2 vs. 4.8 mm), with a 2-year restenosis rate of 19.7% for the EEM-based strategy compared with 33.1% for the lumen-based strategy 15) . These two investigations indicate that selecting sufficiently large balloon sizes might be beneficial to the reduction of restenosis after IVUSguided EVT treatment.…”

“…We reviewed a total of 489 patients with 595 FP lesions who underwent EVT using both DCB and IVUS from a retrospective database of 7 cardiovascular centers. Dual antiplatelet therapy (100 mg/day aspirin with 75 mg/day clopidogrel or 3.75 mg/day prasugrel) was prescribed for at least 1 week prior to EVT and continued for at least 1 month after EVT 15) . Subsequent therapies were at the discretion of the treating physicians.…”

Single-Center Contemporary Clinical Outcomes after Endovascular Treatment in Patients with De Novo Femoropopliteal Lesions between 2017 and 2019

“…Dual-antiplatelet therapy (100 mg/day aspirin with 75 mg/day clopidogrel or 3.75 mg/day prasugrel) was prescribed for at least 1 week prior to EVT and continued at least 1 month after EVT. 10) Subsequent therapies were at the discretion of the treating physicians. Oral anticoagulation was prescribed in patients with atrial fibrillation, deep vein thrombosis, or previous implantation of a mechanical heart valve.…”

Retrospective multicenter registry for endovascular treatment with newer devices in over 25‐cm femoropopliteal artery disease: A retrospective observational study

“…Dual antiplatelet therapy (DAPT; aspirin with clopidogrel or prasugrel) was prescribed for at least 1 week before the EVT and continued at least 1 month. 11 When patients had bleeding complications or high bleeding risks, single antiplatelet therapy (SAPT) could be allowed. 4 Subsequent prescription of the antiplatelet therapy was at the discretion of each treating physician.…”