Yongle Xu1, 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. Electronic address: fu.weiguo@zs-hospital.sh.cn. 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: guowei@301hospital.com.cn.
Abstract
OBJECTIVES: The authors sought to investigate the midterm efficacy and safety of drug-coated balloon (DCB) in the treatment of severe femoropopliteal artery disease (FPAD). BACKGROUND: The midterm outcome of DCB versus uncoated balloon percutaneous transluminal angioplasty (PTA) for FPAD are still debated. METHODS: A total of 200 Chinese patients with FPAD were prospectively randomized into treatment with DCB or with PTA. The primary efficacy endpoints were primary patency of the target lesion, freedom from clinically driven target lesion revascularization, improved ankle-brachial index, and improved Rutherford class at 24 months. The primary safety endpoint was the rate of major adverse events. RESULTS: The DCB group and PTA group were comparable in demographic characteristics and clinical severity at baseline. At 24-month follow-up, primary patency was better in the DCB group versus PTA group (64.6% vs. 31.4%; p < 0.001). The DCB group had a higher rate of freedom from clinically driven target lesion revascularization than the PTA group (86.5% vs. 58.9%; p < 0.001). Rutherford class and ankle-brachial index also confirmed more improvements in the DCB group (p < 0.01 and p < 0.05, respectively). There was no significant difference in major adverse events. CONCLUSIONS: The superiority of DCB versus PTA in the efficacy of FPAD treatment persists at 24-month follow-up and the safety of DCB is equivalent to that of PTA.
RCT Entities:
OBJECTIVES: The authors sought to investigate the midterm efficacy and safety of drug-coated balloon (DCB) in the treatment of severe femoropopliteal artery disease (FPAD). BACKGROUND: The midterm outcome of DCB versus uncoated balloon percutaneous transluminal angioplasty (PTA) for FPAD are still debated. METHODS: A total of 200 Chinese patients with FPAD were prospectively randomized into treatment with DCB or with PTA. The primary efficacy endpoints were primary patency of the target lesion, freedom from clinically driven target lesion revascularization, improved ankle-brachial index, and improved Rutherford class at 24 months. The primary safety endpoint was the rate of major adverse events. RESULTS: The DCB group and PTA group were comparable in demographic characteristics and clinical severity at baseline. At 24-month follow-up, primary patency was better in the DCB group versus PTA group (64.6% vs. 31.4%; p < 0.001). The DCB group had a higher rate of freedom from clinically driven target lesion revascularization than the PTA group (86.5% vs. 58.9%; p < 0.001). Rutherford class and ankle-brachial index also confirmed more improvements in the DCB group (p < 0.01 and p < 0.05, respectively). There was no significant difference in major adverse events. CONCLUSIONS: The superiority of DCB versus PTA in the efficacy of FPAD treatment persists at 24-month follow-up and the safety of DCB is equivalent to that of PTA.