Xin Jia1, Jiwei Zhang2, Baixi Zhuang3, Weiguo Fu4, Danming Wu5, Feng Wang6, Yu Zhao7, Pingfan Guo8, Wei Bi9, Shenming Wang10, Wei Guo11. 1. Chinese PLA General Hospital, Beijing, China. 2. Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. 3. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China. 4. Zhongshan Hospital Fudan University, Shanghai, China. 5. The People's Hospital of Liaoning Province, Shenyang, China. 6. The First Affiliated Hospital of Dalian Medical University, Dalian, China. 7. The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. 8. The First Affiliated Hospital of Fujian Medical University, Fuzhou, China. 9. The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China. 10. The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. 11. Chinese PLA General Hospital, Beijing, China. Electronic address: pla301dml@vip.sina.com.
Abstract
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.
RCT Entities:
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.
Authors: Jordan A Anderson; Sujan Lamichhane; Kirby Fuglsby; Tyler Remund; Kathryn Pohlson; Rick Evans; Daniel Engebretson; Patrick Kelly Journal: J Vasc Surg Date: 2019-09-10 Impact factor: 4.268
Authors: Gary M Ansel; Marianne Brodmann; Koen Keirse; Antonio Micari; Michael R Jaff; Krishna Rocha-Singh; Eric J Fernandez; Hong Wang; Thomas Zeller Journal: J Endovasc Ther Date: 2018-10-03 Impact factor: 3.487