法国关于 LUMINOR 药物洗脱球囊治疗股浅动脉和腘动脉的多中心登记。

IF 3.9 2区 医学 Q1 PERIPHERAL VASCULAR DISEASE
Caroline Caradu, Claire Webster, Bahaa Nasr, Jonathan Sobocinski, Nicolas Louis, Benjamin Thévenin, Gilles Goyault, Yann Goueffic, Eric Ducasse
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引用次数: 0

摘要

背景:使用药物涂层球囊(DCB)进行血管内介入治疗有望改善股骨头血运重建的疗效。基于纳米技术的紫杉醇涂层球囊 Luminor 在 Effpac 试验中证明了其有效性和安全性。LUMIFOLLOW 登记是一项大规模、前瞻性、多中心研究,旨在评估 Luminor 在股骨头病变中的实际表现:LUMIFOLLOW登记了15个法国中心的542名患者,共580处病变。其中包括钙化和/或长闭塞的新发病变和再狭窄病变。主要终点为医疗安全性(定义为无围手术期死亡、指数肢体截肢和/或全因死亡率)和有效性(主要通畅性定义为无靶病变血管再通(f-TLR)和/或二元再狭窄);次要终点包括急性装置成功率、手术和临床成功率、主要不良事件和功能评估:患者平均年龄为71.2岁,67.2%为男性。普遍合并症包括糖尿病(42.6%,n=231/542)、高血压(72.1%,n=391/542)、高脂血症(56.3%,n=305/542)和当前吸烟(27.2%,n=147/540);23.8%为卢瑟福分级(RC)2级(n=129/542),43.2%为RC 3级(n=234/542),16.8%为RC 4级(n=91/542),16.2%为RC 5级(n=88/542)。病变位于股浅动脉(57.5%,n=329/572),可延伸至腘动脉(42.5%,n=243/572),43.6%被归类为TASC II C-D;24.2%为再狭窄(n=139/575),44.3%为全闭塞(n=255/576)。平均病变长度为(140.55±99.42)毫米。43.1%的患者(n=249/580)需要临时支架,平均支架长度比初始病变长度短(87.21±42.30毫米)。急性手术成功率为 99.4%(n=536/539),2 例院内死亡,1 例目标病变血栓形成。急性临床成功率为93.5%(n=504/539)。12个月综合安全终点为82.7%(5.7%全因死亡,0.7%主要截肢),估计主要通畅率为87.4%(95%CI:84.1;90.1%),f-TLR为96.2%(95%CI:93.9;97.6%),靶血管再通率为94.9%(95%CI:92.5;96.6%)。EQ-5D-5L调查问卷显示,12个月后,患者的生活质量明显改善,67.4%的患者活动能力得到改善,63.5%的患者疼痛和不适感减轻,47.8%的患者日常活动能力增强。步行障碍问卷的步行距离、速度和爬楼梯能力得分明显增加(从(31.4±24.7)分增加到(62.5±31.0)分,p结论:LUMIFOLLOW 登记结果表明,Luminor DCB 用于股骨头介入治疗既有效又安全。生活质量和行走能力的明显改善,以及高初次通畅率和低并发症发生率,凸显了 Luminor DCB 在实际环境中的优势。不过,临时支架植入率较高,这突出表明这些设备需要与其他血管内技术一起用于具有挑战性的病变。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
French Multicentric Registry on LUMINOR Drug-Eluting Balloon for Superficial Femoral and Popliteal Arteries.

Background: Endovascular interventions using drug-coated balloons (DCBs) have shown promise in improving outcomes for femoropopliteal revascularizations. Luminor, nanotechnology-based paclitaxel coated balloon, has demonstrated efficacy and safety in the Effpac trial. The LUMIFOLLOW registry, a large-scale, prospective, multicenter study, aims to assess the real-world performance of Luminor in femoropopliteal lesions.

Methods: LUMIFOLLOW enrolled 542 patients with 580 lesions across 15 French centers. It included both de novo and restenotic lesions, with calcified and/or long occlusions. Primary endpoints were medical safety (defined as freedom from peri-procedural death, index limb amputation, and/or all-cause mortality) and efficacy (primary patency defined as freedom from target lesion revascularization (f-TLR) and/or binary restenosis); secondary endpoints included acute device success, procedural and clinical success, major adverse events, and functional assessments.

Results: The mean age was 71.2 years, with 67.2% male patients. Prevalent comorbidities included diabetes (42.6% n=231/542), hypertension (72.1%, n=391/542), hyperlipidemia (56.3%, n=305/542) and current smoking (27.2%, n=147/540); 23.8% were classified as Rutherford classification (RC) 2 (n=129/542), 43.2% as RC 3 (n=234/542), 16.8% as RC 4 (n=91/542) and 16.2% as RC 5 (n=88/542). Lesions were located in the superficial femoral artery (57.5%, n=329/572) and could extend to the popliteal artery (42.5%, n=243/572), with 43.6% classified TASC II C-D; 24.2% were restenosis (n=139/575) with a 44.3% rate of total occlusions (n=255/576). Mean lesion length was 140.55±99.42mm. Provisional stenting was required in 43.1% (n=249/580) with a mean stent length shorter than the initial lesion length at 87.21±42.30mm. The acute procedural success rate was 99.4% (n=536/539), with 2 in-hospital deaths and one thrombosis of target lesion. Acute clinical success was achieved in 93.5% (n=504/539). The 12-month composite safety endpoint was 82.7% (5.7% all-cause mortality, 0.7% index limb major amputation) and estimated primary patency was 87.4% (95%CI: 84.1;90.1%), with f-TLR at 96.2% (95%CI: 93.9;97.6%) and from target vessel revascularization at 94.9% (95%CI: 92.5;96.6%). The EQ-5D-5L questionnaire indicated significant improvements in quality of life at 12 months, with 67.4% improved mobility, 63.5% reduced pain and discomfort, and 47.8% enhanced usual activities. Walking Impairment Questionnaire scores increased significantly in walking distance, speed, and stair-climbing ability (from 31.4±24.7 to 62.5±31.0, p<.001).

Conclusion: The LUMIFOLLOW registry demonstrates that Luminor DCBs are effective and safe for femoropopliteal interventions. The significant improvement in quality of life and walking ability, along with high primary patency and low complication rates, underscore the benefits of Luminor DCBs in real-world settings. However, the high rate of provisional stenting underscores the need for these devices to be used alongside other endovascular techniques in challenging lesions.

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来源期刊
CiteScore
7.70
自引率
18.60%
发文量
1469
审稿时长
54 days
期刊介绍: Journal of Vascular Surgery ® aims to be the premier international journal of medical, endovascular and surgical care of vascular diseases. It is dedicated to the science and art of vascular surgery and aims to improve the management of patients with vascular diseases by publishing relevant papers that report important medical advances, test new hypotheses, and address current controversies. To acheive this goal, the Journal will publish original clinical and laboratory studies, and reports and papers that comment on the social, economic, ethical, legal, and political factors, which relate to these aims. As the official publication of The Society for Vascular Surgery, the Journal will publish, after peer review, selected papers presented at the annual meeting of this organization and affiliated vascular societies, as well as original articles from members and non-members.
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