Yongle Xu1, Jie Liu1, Jiwei Zhang2, Baixi Zhuang3, Xin Jia1, Weiguo Fu4, Danming Wu5, Feng Wang6, Yu Zhao7, Pingfan Guo8, Wei Bi9, Shenming Wang10, Wei Guo11. 1. Department of Vascular Surgery, Chinese PLA General Hospital, Beijing, China. 2. Department of Vascular Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. 3. Department of Peripheral Vascular Disease, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China. 4. Department of Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, China. 5. Department of Vascular Surgery, The People's Hospital of Liaoning Province, Shenyang, Shenyang, China. 6. Department of Interventional Therapy, First Affiliated Hospital of Dalian Medical University, Dalian, China. 7. Department of Vascular Surgery, First Affiliated Hospital of Chongqing Medical University, Chongqing, China. 8. Department of Vascular Surgery, First Affiliated Hospital of Fujian Medical University, Fuzhou, China. 9. Department of Vascular Surgery, Second Hospital of Hebei Medical University, Shijiazhuang, China. 10. Department of Vascular Surgery, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. 11. Department of Vascular Surgery, Chinese PLA General Hospital, Beijing, China. Electronic address: guoweiplagh@sina.com.
Abstract
OBJECTIVE: We evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD). METHODS: In this prospective, multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment. RESULTS: During the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period. CONCLUSIONS: We found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.
RCT Entities:
OBJECTIVE: We evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD). METHODS: In this prospective, multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment. RESULTS: During the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period. CONCLUSIONS: We found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.