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药物涂层球囊血管成形术在真实世界股腘动脉队列中的三年持续临床疗效

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.

作者信息

Torsello Giovanni, Stavroulakis Konstantinos, Brodmann Marianne, Micari Antonio, Tepe Gunnar, Veroux Pierfrancesco, Benko Andrew, Choi Donghoon, Vermassen Frank E G, Jaff Michael R, Guo Jia, Dobranszki Reka, Zeller Thomas

机构信息

Department of Vascular Surgery, St Franziskus-Hospital Münster, Germany.

Department of Vascular Surgery, Ludwig-Maximilians-University Hospital Munich, Germany.

出版信息

J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.

Abstract

To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

摘要

报告前瞻性、多中心、单臂IN.PACT全球研究(标识符NCT01609296)的36个月结果,该研究评估了IN.PACT Admiral药物涂层球囊(DCB)在现实世界中患有股腘动脉闭塞性疾病患者中的性能。IN.PACT全球研究在64个国际地点进行,招募了1535例患有复杂病变的患者,这些病变包括双侧疾病、多处病变、新发支架内再狭窄、长病变和慢性完全闭塞。预定义的完整临床队列包括1406例患者(平均年龄68.6岁;67.8%为男性),他们因间歇性跛行或静息痛接受了研究DCB治疗。平均病变长度为12.09±9.54厘米;18.0%有支架内再狭窄,35.5%完全闭塞,68.7%钙化。通过36个月评估无临床驱动的靶病变血管重建(CD-TLR)情况。安全复合终点是30天内无器械和手术相关死亡,以及36个月内无主要靶肢体截肢和临床驱动的靶血管重建。所有安全和血管重建事件均由独立的临床事件委员会进行审查。36个月时无CD-TLR的Kaplan-Meier估计值为76.9%。75.6%的患者达到了复合安全终点。36个月的全因死亡率为11.6%,主要靶肢体截肢率为1.0%。与间歇性跛行患者相比,慢性肢体威胁性缺血(CLTI)患者36个月时无CD-TLR的Kaplan-Meier估计值显著更低(67.6%对78.0%;p = 0.003)。累及股浅动脉(SFA)和腘动脉的病变36个月时无CD-TLR的Kaplan-Meier自由度(69.2%)低于孤立的SFA病变(79.7%)或腘动脉病变(76.5%;对数秩p<0.001)。36个月时CD-TLR的预测因素包括病变长度增加、参考血管直径≤4.5毫米、支架内再狭窄、双侧疾病、CLTI和高脂血症。在一个多样化且复杂的现实世界人群中,使用IN.PACT Admiral DCB对股腘动脉疾病进行DCB血管成形术与初始手术后3年持续的临床疗效和低再干预率相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6116/7545651/a7ebceb59438/10.1177_1526602820931477-fig1.jpg

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