Toyoshima Taku, Iida Osamu, Takahara Mitsuyoshi, Okamoto Shin, Ishihara Takayuki, Nanto Kiyonori, Tsujimura Takuya, Hata Yosuke, Higashino Naoko, Nakao Sho, Tsukizawa Tomofumi, Nishian Kunihiko, Fujihara Masahiko, Kawasaki Daizo, Mano Toshiaki
Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.
Departments of Diabetes Care Medicine and Metabolic Medicine, Graduate School of Medicine, Osaka University, Suita, Japan.
J Endovasc Ther. 2025 Jun;32(3):746-755. doi: 10.1177/15266028231186717. Epub 2023 Jul 21.
Clinical trials have demonstrated the superiority of drug-coated balloon (DCB) to noncoated balloon angioplasty for the treatment of femoropopliteal (FP) lesions. In those trials, the difference of primary patency between DCB and noncoated angioplasty widens especially after 6 months, speculating that the antirestenosis effect of paclitaxel is manifested after 6 months. Factors associated with restenosis after 6 months differ from those associated with restenosis within 6 months. This study aimed to elucidate the prognostic factors associated with early (within 6 months) and late (after 6 months) restenosis following DCB treatment in real-world FP practice.
This multicenter, retrospective study analyzed 486 FP lesions (mean lesion length, 11.9±10.1 cm; chronic total occlusion, 21.0%) in 423 patients (diabetes mellitus, 59.3%; hemodialysis, 37.1%; chronic limb-threatening ischemia, 41.6%) who underwent successful DCB treatment between January 2018 and December 2019. The outcome measure was restenosis which is defined as a peak systolic velocity ratio >2.4 based on duplex ultrasound findings. Early and late restenosis were classified by the cutoff period of 6 months after the procedure. The associations of baseline and procedural characteristics with early and late restenosis were explored using Cox proportional hazards regression analysis.
The mean follow-up period was 25.3±12.1 months. The 6, 12, 18, and 24 month cumulative incidences of restenosis were 7.4%±2.4%, 20.9%±3.9%, 29.9%±4.5%, and 38.4%±5.1%, respectively. During the follow-up period, early and late restenosis was evident in a total of 31 lesions and 138 lesions, respectively. Multivariate analysis revealed that chronic total occlusion (hazard ratio [HR], 2.29; 95% confidence interval [CI], 1.07-4.92; p=0.033) and superficial femoral artery ostial lesion (HR, 2.73; 95% CI, 1.28-5.80; p=0.009) were significantly associated with early restenosis. On the other hand, calcification circumference over 270° (HR, 1.67; 95% CI, 1.17-2.37; p=0.004), distal external elastic membrane diameter under 5 mm assessed by intravascular ultrasound (HR, 1.90; 95% CI, 1.29-2.79; p=0.001), and involving popliteal arterial lesion (HR, 1.54; 95% CI, 1.08-2.21; p=0.017) were significantly associated with late restenosis.
The prognostic factors associated with late restenosis differed from those associated with early restenosis in the real-world FP-DCB practice.Clinical ImpactThe current multicenter, retrospective study revealed that factors associated with early restenosis differed from those with late restenosis in the real-world FP-DCB practice. CTO and SFA ostial lesion were associated with early restenosis, while severe calcification, smaller vessel, and involving popliteal arterial lesions were associated with late restenosis.Early restenosis indicates "balloon failure" and would potentially result from recoil, which primary stent implantation might be required. On the other hand, late restenosis after 6 months would be attributed to "DCB failure", with inadequate drug uptake into the arterial wall, which might be minimized by the use of atherectomy devices.
临床试验已证明药物涂层球囊（DCB）在治疗股腘（FP）病变方面优于非涂层球囊血管成形术。在这些试验中，DCB与非涂层血管成形术之间的主要通畅率差异尤其在6个月后扩大，推测紫杉醇的抗再狭窄作用在6个月后显现。6个月后与再狭窄相关的因素与6个月内与再狭窄相关的因素不同。本研究旨在阐明在现实世界的FP治疗中，DCB治疗后早期（6个月内）和晚期（6个月后）再狭窄的预后因素。
这项多中心回顾性研究分析了2018年1月至2019年12月期间接受DCB成功治疗的423例患者中的486处FP病变（平均病变长度11.9±10.1cm；慢性完全闭塞21.0%）（糖尿病59.3%；血液透析37.1%；慢性肢体威胁性缺血41.6%）。结局指标为再狭窄，根据双功超声检查结果定义为收缩期峰值流速比>2.4。早期和晚期再狭窄根据术后6个月的截止期进行分类。使用Cox比例风险回归分析探讨基线和手术特征与早期和晚期再狭窄的相关性。
平均随访期为25.3±12.1个月。再狭窄的6个月、12个月、18个月和24个月累积发生率分别为7.4%±2.4%、20.9%±3.9%、29.9%±4.5%和38.4%±5.1%。在随访期间，早期和晚期再狭窄分别在31处病变和138处病变中明显。多变量分析显示，慢性完全闭塞（风险比[HR]，2.29；95%置信区间[CI]，1.07 - 4.92；p = 0.033）和股浅动脉开口处病变（HR，2.73；95%CI，1.28 - 5.80；p = 0.009）与早期再狭窄显著相关。另一方面，钙化周长超过270°（HR，1.67；95%CI，1.17 - 2.37；p = 0.004）、血管内超声评估的远端外弹力膜直径小于5mm（HR，1.90；95%CI，1.29 - 2.79；p = 0.001）以及累及腘动脉病变（HR，1.54；95%CI，1.08 - 2.21；p = 0.017）与晚期再狭窄显著相关。
在现实世界的FP - DCB治疗中，与晚期再狭窄相关的预后因素与早期再狭窄不同。
临床影响
当前的多中心回顾性研究表明，在现实世界的FP - DCB治疗中，与早期再狭窄相关的因素与晚期再狭窄不同。慢性完全闭塞和股浅动脉开口处病变与早期再狭窄相关，而严重钙化、血管较小和累及腘动脉病变与晚期再狭窄相关。早期再狭窄表明“球囊失败”，可能是由回缩导致的，可能需要植入初级支架。另一方面，6个月后的晚期再狭窄将归因于“DCB失败”，药物向动脉壁的摄取不足，使用旋切装置可能会将其最小化。
