Bo Xu1, Runlin Gao2, Jian'an Wang3, Yuejin Yang1, Shaoliang Chen4, Bin Liu5, Fang Chen6, Zhanquan Li7, Yaling Han8, Guosheng Fu9, Yelin Zhao1, Junbo Ge10. 1. Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China. 2. Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China. Electronic address: gaorunlin@citmd.com. 3. Department of Cardiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. 4. Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. 5. Department of Cardiology, Jilin University the Second Hospital, Changchun, China. 6. Department of Cardiology, Affiliated Anzhen Hospital of Capital Medical University, Beijing, China. 7. Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China. 8. Department of Cardiology, Shenyang Northern Hospital, Shenyang, China. 9. Department of Cardiology, Affiliated SRRS Hospital of Zhejiang University School of Medicine, Hangzhou, China. 10. Department of Cardiology, Affiliated Zhongshan Hospital of Fudan University, Shanghai, China.
Abstract
OBJECTIVES: The intention of the PEPCAD China ISR (A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis) was to demonstrate the efficacy of paclitaxel-coated balloon (PCB) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR). BACKGROUND: The treatment of DES-ISR is still challenging with no established best strategy. Moreover, there is no study on the effect of PCB in the treatment of ISR in the Chinese population. METHODS: PEPCAD China ISR was a 220-patient randomized (1:1), single-blind prospective multicenter trial conducted in China. Patients with coronary DES-ISR received either PCB (SeQuent Please, B. Braun Melsungen AG, Melsungen, Germany) or paclitaxel-eluting stent (Taxus Liberté, Boston Scientific, Natick, Massachusetts) treatment. The primary endpoint was in-segment late lumen loss at 9 months. RESULTS: There were no significant baseline differences between both treatment groups in terms of patient, lesion, or procedural characteristics. At 9 months, in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group (0.46 ± 0.51 mm vs. 0.55 ± 0.61 mm; difference: -0.06 mm with 95% confidence interval: -0.23 to 0.10; p for noninferiority = 0.0005). The 9-month rate of binary restenosis and 12-month composite clinical event rates were not significantly different between groups. CONCLUSIONS: In a randomized trial of 220 patients, angioplasty with aPCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR. On the basis of these, as well as previous randomized trial data, PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release. (A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent [PEPCAD]; NCT01622075).
RCT Entities:
OBJECTIVES: The intention of the PEPCAD China ISR (A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis) was to demonstrate the efficacy of paclitaxel-coated balloon (PCB) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR). BACKGROUND: The treatment of DES-ISR is still challenging with no established best strategy. Moreover, there is no study on the effect of PCB in the treatment of ISR in the Chinese population. METHODS: PEPCAD China ISR was a 220-patient randomized (1:1), single-blind prospective multicenter trial conducted in China. Patients with coronary DES-ISR received either PCB (SeQuent Please, B. Braun Melsungen AG, Melsungen, Germany) or paclitaxel-eluting stent (Taxus Liberté, Boston Scientific, Natick, Massachusetts) treatment. The primary endpoint was in-segment late lumen loss at 9 months. RESULTS: There were no significant baseline differences between both treatment groups in terms of patient, lesion, or procedural characteristics. At 9 months, in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group (0.46 ± 0.51 mm vs. 0.55 ± 0.61 mm; difference: -0.06 mm with 95% confidence interval: -0.23 to 0.10; p for noninferiority = 0.0005). The 9-month rate of binary restenosis and 12-month composite clinical event rates were not significantly different between groups. CONCLUSIONS: In a randomized trial of 220 patients, angioplasty with a PCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR. On the basis of these, as well as previous randomized trial data, PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release. (A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent [PEPCAD]; NCT01622075).