Author + information
- Received May 4, 2016
- Revision received June 6, 2016
- Accepted June 20, 2016
- Published online September 26, 2016.
- Xin Jia, MDa,
- Jiwei Zhang, MDb,
- Baixi Zhuang, MDc,
- Weiguo Fu, MDd,
- Danming Wu, MDe,
- Feng Wang, MDf,
- Yu Zhao, MDg,
- Pingfan Guo, MDh,
- Wei Bi, MDi,
- Shenming Wang, MDj and
- Wei Guo, MDa,∗ ()
- aChinese PLA General Hospital, Beijing, China
- bRenji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
- cXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
- dZhongshan Hospital Fudan University, Shanghai, China
- eThe People’s Hospital of Liaoning Province, Shenyang, China
- fThe First Affiliated Hospital of Dalian Medical University, Dalian, China
- gThe First Affiliated Hospital of Chongqing Medical University, Chongqing, China
- hThe First Affiliated Hospital of Fujian Medical University, Fuzhou, China
- iThe Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China
- jThe First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- ↵∗Reprint requests and correspondence:
Dr. Wei Guo, Vascular Surgery Department, Fuxing Road 28, Beijing 100853, China.
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.
This study was supported by an unrestricted grant from Acotec. All authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Jia, Zhang, and Zhuang contributed equally to this work. Drs. Guo and Fu have overall responsibility.
- Received May 4, 2016.
- Revision received June 6, 2016.
- Accepted June 20, 2016.
- American College of Cardiology Foundation