Kurata Naoya, Iida Osamu, Takahara Mitusyoshi, Asai Mitsutoshi, Masuda Masaharu, Okamoto Shin, Ishihara Takayuki, Nanto Kiyonori, Kanda Takashi, Tsujimura Takuya, Matsuda Yasuhiro, Hata Yousuke, Mano Toshiaki
Cardiovascular Center, Department of Clinical Engineering, Kansai Rosai Hospital, Amagasaki, Japan.
Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan.
J Endovasc Ther. 2023 Apr;30(2):269-280. doi: 10.1177/15266028221081082. Epub 2022 Mar 6.
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.
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.
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).
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.
尽管在股腘动脉（FP）血管内治疗（EVT）期间，药物涂层球囊（DCB）的尺寸是根据血管直径确定的，但血管直径的测量在不同方式及其定义之间存在差异。本研究的目的是揭示DCB尺寸适配（1）血管造影测量的管腔直径（血管造影管腔尺寸）、（2）血管内超声（IVUS）测量的管腔直径（IVUS管腔尺寸）或（3）IVUS测量的外弹力膜（EEM）直径（IVUS-EEM尺寸）是否对再狭窄的发生有益。
这项回顾性单中心研究纳入了165例接受IN.PACT Admiral DCB治疗且经IVUS评估的外周动脉疾病患者中的231处初发FP病变。参考血管直径被评估为病变远端健康部位的管腔或EEM直径。我们回顾性确定DCB尺寸是否接近（即等于或与……相差<0.5 mm）血管造影管腔尺寸、IVUS管腔尺寸和IVUS-EEM尺寸。研究了DCB尺寸与再狭窄风险的关联。
平均病变长度为13±9 cm，慢性完全闭塞的患病率为18%。在平均17±9个月的随访期内，26%的病变发生了再狭窄。采用IVUS-EEM尺寸DCB治疗的病变2年再狭窄率低于采用大于或小于IVUS-EEM尺寸DCB治疗的病变（19.7±5.7%对34.5±4.7%，对数秩检验p=0.02），而血管造影管腔尺寸或IVUS管腔尺寸的DCB与大于或小于该尺寸的DCB之间的再狭窄率无显著差异（均p>0.05）。多因素Cox回归分析显示，IVUS-EEM尺寸的DCB与再狭窄风险降低独立相关（调整后的风险比为0.50；95%置信区间为0.27-0.95；p=0.03）。
IVUS-EEM尺寸的DCB，而非血管造影管腔尺寸或IVUS管腔尺寸的DCB，与FP-EVT后再狭窄风险降低相关。根据IVUS评估的EEM直径确定DCB尺寸可能对再狭窄的发生有益。
