Clinical Outcomes Following Low-Dose Second-Generation "Ranger" Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease.

IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE
Yoshimitsu Soga, Mitsuyoshi Takahara, Osamu Iida, Daizo Kawasaki, Kazuki Tobita, Masahiko Fujihara
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引用次数: 0

Abstract

Purpose: To reveal the rate of 1-year freedom from restenosis and to determine the factors associated with the restenosis risk in femoropopliteal (FP) lesions treated with a Ranger drug-coated balloon (DCB) in real-world clinical settings.

Methods: This multicenter, prospective observational study enrolled 1131 patients and 1453 de novo or restenotic FP lesions (mean age=75±9 years; female=35.3%, mean lesion length=19.2±16.0 cm; chronic total occlusion [CTO]=33.7%; severe calcification=33.7%) that underwent successful Ranger DCB angioplatsy between March 2021 and December 2022.

Results: The primary endpoint was 1-year freedom from restenosis and its associated factors. Bail-out stenting was performed in 5.3%. During the follow-up, restenosis was detected in 249 cases. Freedom from restenosis by the Kaplan-Meier analysis was estimated to be 85.2% and 81.0% at 12 and 14 months, whereas freedom from target lesion revascularization (TLR) was 91.7% and 90.0% at 12 and 14 months. The patterns of restenosis were focal (39.2%), tandem (12.3%), diffuse (17.2%), and occlusive (31.3%). Independent risk factors of restenosis were female sex, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.

Conclusions: Our study demonstrated that 1-year freedom from restenosis after Ranger DCB for FP lesions in a real-world clinical setting was acceptable. Independent predictors of restenosis were female gender, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.

Clinical impact: Our study demonstrated the true performance of Ranger DCB in real-world practice, with a very low rate of bail-out stenting and no use of atherectomy devices. In addition, it also elucidated morphologies associated with restenosis and the risk factors for restenosis after DCB. Freedom from re-stenosis and TLR at 1-year after Range DCB angioplasty was 84.5% and 91.5%. Two thirds of restenosis had a non-occlusive pattern, and independent predictors of restenosis were female gender, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.

低剂量第二代 "Ranger "药物涂层球囊血管成形术治疗股腘动脉疾病的临床效果。
目的:揭示在实际临床环境中使用 Ranger 药物涂层球囊(DCB)治疗股骨腘动脉(FP)病变的 1 年无再狭窄率,并确定与再狭窄风险相关的因素:这项多中心前瞻性观察研究招募了1131名患者和1453个新发或再狭窄的FP病变(平均年龄=75±9岁;女性=35.3%,平均病变长度=19.2±16.0厘米;慢性全闭塞[CTO]=33.7%;严重钙化=33.7%),这些患者在2021年3月至2022年12月期间成功接受了Ranger DCB血管成形术:主要终点是1年内无再狭窄及其相关因素。5.3%的患者接受了支架置换术。在随访期间,有249例发现了再狭窄。根据卡普兰-梅耶尔分析,在12个月和14个月时,再狭窄发生率分别为85.2%和81.0%,而在12个月和14个月时,靶病变血运重建(TLR)发生率分别为91.7%和90.0%。再狭窄的模式有局灶性(39.2%)、串联性(12.3%)、弥漫性(17.2%)和闭塞性(31.3%)。再狭窄的独立风险因素为女性、糖尿病、无径流、血管再通史、病变长度≥25厘米和CTO:我们的研究表明,在真实的临床环境中,Ranger DCB治疗FP病变后1年内无再狭窄是可以接受的。再狭窄的独立预测因素是女性、糖尿病、无径流、血管再通史、病变长度≥25厘米和CTO:我们的研究证明了 Ranger DCB 在实际应用中的真实表现,保外支架植入率非常低,而且没有使用动脉粥样硬化切除装置。此外,研究还阐明了与再狭窄相关的形态以及DCB术后再狭窄的风险因素。范围DCB血管成形术后1年的再狭窄和TLR发生率分别为84.5%和91.5%。三分之二的再狭窄为非闭塞模式,女性、糖尿病、无径流、血管再通史、病变长度≥25厘米和CTO是再狭窄的独立预测因素。
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来源期刊
CiteScore
5.30
自引率
15.40%
发文量
203
审稿时长
6-12 weeks
期刊介绍: The Journal of Endovascular Therapy (formerly the Journal of Endovascular Surgery) was established in 1994 as a forum for all physicians, scientists, and allied healthcare professionals who are engaged or interested in peripheral endovascular techniques and technology. An official publication of the International Society of Endovascular Specialists (ISEVS), the Journal of Endovascular Therapy publishes peer-reviewed articles of interest to clinicians and researchers in the field of peripheral endovascular interventions.
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