title: Acotec Drug-Coated Balloon Catheter: Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial.
abstract: 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.
  
  
  
  The incidence of restenosis can be reduced by the use of drug-coated balloons. However, dose, coating composition, and technology are decisive for efficacy.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Jia
authors.affiliation: Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Jiwei
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Baixi
authors.initials: B
authors.lastname: Zhuang
authors.affiliation: Zhongshan Hospital Fudan University, Shanghai, China.
authors.forename: Weiguo
authors.initials: W
authors.lastname: Fu
authors.affiliation: The People's Hospital of Liaoning Province, Shenyang, China.
authors.forename: Danming
authors.initials: D
authors.lastname: Wu
authors.affiliation: The First Affiliated Hospital of Dalian Medical University, Dalian, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Wang
authors.affiliation: The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
authors.forename: Pingfan
authors.initials: P
authors.lastname: Guo
authors.affiliation: The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Bi
authors.affiliation: The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
authors.forename: Shenming
authors.initials: S
authors.lastname: Wang
authors.affiliation: Chinese PLA General Hospital, Beijing, China. Electronic address: pla301dml@vip.sina.com.
authors.forename: Wei
authors.initials: W
authors.lastname: Guo
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; D000792:Angiography; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D020099:Coated Materials, Biocompatible; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: drug-coated balloon catheter; femoropopliteal disease; randomized clinical trial; restenosis inhibition