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Acotec Drug-Coated Balloon Catheter Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial 期刊论文

编号：

ebf1780d-7a9b-45f7-a25d-2e27f1f78c10
作者：

Jia, Xin^[1] Zhang, Jiwei^[2] Zhuang, Baixi^[3] Fu, Weiguo^[4] Wu, Danming^[5] Wang, Feng^[6] Zhao, Yu^[7] Guo, Pingfan^[8] Bi, Wei^[9] Wang, Shenming^[10] Guo, Wei^[1]
语种：

English
期刊：

JACC-CARDIOVASCULAR INTERVENTIONS ISSN：1936-8798 2016 年 9 卷 18 期 (1941 - 1949) ; SEP 26
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关键词：

drug-coated balloon catheter femoropopliteal disease randomized clinical trial restenosis inhibition
摘要：

OBJECTIVES The aim of this study was to investigate the efficacy and safety of a new paclitaxel-coated balloon catheter in the treatment of stenotic or occluded femoropopliteal arteries. BACKGROUND The incidence of restenosis can be reduced by the use of drug-coated balloons. However, dose, coating composition, and technology are decisive for efficacy. METHODS Two hundred Chinese patients with peripheral arterial occlusive disease were prospectively randomized to treatment with new paclitaxel-coated or standard uncoated balloon catheters. The primary endpoint was angiographic late lumen loss at 6 months, measured by a blinded core laboratory. Secondary angiographic endpoints (6 months) and specific clinical endpoints (1 year) were binary restenosis, ankle-brachial index, Rutherford stage, clinically driven target lesion revascularization, and amputation. RESULTS Patients' mean age was 66 years, 74% were men, 31% were smokers, and 55% had diabetes. Patients were in Rutherford stages 2 through 5, with a mean lesion length of 150 mm; 25% had in-stent restenosis, 55% had occlusion or partial occlusion, and 20% underwent provisional stenting. Late lumen loss at 6 months was available for 89%, and clinical follow-up was available for > 95% per group. Mean late lumen loss was 0.05 +/- 0.73 mm with coated balloons and 1.15 +/- 0.89 mm with uncoated balloons (p < 0.001). Correspondingly, the rates of restenosis were 22.5% and 70.8% (p < 0.001). After 1 year, the rates of target lesion revascularization were 7.2% and 39.6% (p < 0.001), and Rutherford class and ankle-brachial index improved more markedly in the coated group (p < 0.046 and p = 0.023, respectively). One major amputation was recorded in the control group. No coating-related adverse events were observed for doses of up to 43 mg paclitaxel per patient. CONCLUSIONS In this medium-sized trial with long superficial femoral artery lesions, the use of paclitaxel-coated balloon catheters markedly improved angiographic and clinical outcomes of interventions despite advanced disease in the majority of patients. (C) 2016 by the American College of Cardiology Foundation.
推荐引用方式
GB/T 7714：

Jia Xin,Zhang Jiwei,Zhuang Baixi, et al. Acotec Drug-Coated Balloon Catheter Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial [J].JACC-CARDIOVASCULAR INTERVENTIONS,2016,9(18):1941-1949.
APA：

Jia Xin,Zhang Jiwei,Zhuang Baixi,Fu Weiguo,&Guo Wei.(2016).Acotec Drug-Coated Balloon Catheter Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial .JACC-CARDIOVASCULAR INTERVENTIONS,9(18):1941-1949.
MLA：

Jia Xin, et al. "Acotec Drug-Coated Balloon Catheter Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial" .JACC-CARDIOVASCULAR INTERVENTIONS 9,18(2016):1941-1949.

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