A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results

医学 紫杉醇 气球 失调家庭 药品 放射科 外科 药理学 化疗 精神科
作者
Dimitrios Karnabatidis,Panagiotis Kitrou,Pedro Ponce,Tze Tec Chong,Radosław Pietura,Jean-Dominique Pegis,Po‐Jen Ko,Chia Hsun Lin,Dimitrios Karnabatidis,Pedro Ponce,Tze Tec Chong,Radosław Pietura,Jean-Dominique Pegis,Po‐Jen Ko,Chia Hsun Lin,Matteo Tozzi,Carlos Lucas,John Chien-Hwa Chang,Hannes Deutschmann,Ounali Jaffer,Ángel Ferrario,Guido Saracino,Kate Steiner,Jackie Pei Ho,Jos Van Den Berg,Benoît Boura,Dmytro Mishunin,Farhan Ahmad,Ulf Teichgraeber,Roberto Cioni,Hsuan‐Li Huang,Mohammad Arabi,Daniele Savio
出处
期刊:Journal of Vascular and Interventional Radiology [Elsevier BV]
卷期号:32 (3): 360-368.e2 被引量:12
标识
DOI:10.1016/j.jvir.2020.11.018
摘要

To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population.This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints.The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for ≥120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005).The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas.
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