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

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• 作者：Xin Jia ; MD^a ; Jiwei Zhang ; MD^b ; Baixi Zhuang ; MD^c ; Weiguo Fu ; MD^d ; Danming Wu ; MD^e ; Feng Wang ; MD^f ; Yu Zhao ; MD^g ; Pingfan Guo ; MD^h ; Wei Bi ; MDⁱ ; Shenming Wang ; MD^j ; Wei Guo ; MD^a ; ^{pla301dml@vip.sina.com" class="auth_mail" title="E-mail the corresponding author}
• 关键词：drug-coated balloon catheter ; femoropopliteal disease ; randomized clinical trial ; restenosis inhibition
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2016
• 出版时间：26 September 2016
• 年：2016
• 卷：9
• 期：18
• 页码：1941-1949
• 全文大小：584 K

文摘

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.