Author + information
- Received April 25, 2018
- Revision received July 10, 2018
- Accepted July 24, 2018
- Published online December 3, 2018.
- Yongle Xu, MDa,∗,
- 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
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.
- drug-coated balloon
- femoropopliteal artery disease
- midterm follow-up
- percutaneous transluminal angioplasty
↵∗ Drs. Xu, Jia, Zhang, and Zhuang contributed equally to this work.
This study was supported by an unrestricted grant from Acotec. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 25, 2018.
- Revision received July 10, 2018.
- Accepted July 24, 2018.
- 2018 American College of Cardiology Foundation
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