title: A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial.
abstract: OBJECTIVE
  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).
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China. Electronic address: gaorunlin@citmd.com.
authors.forename: Runlin
authors.initials: R
authors.lastname: Gao
authors.affiliation: Department of Cardiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: Jian'an
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China.
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Shaoliang
authors.initials: S
authors.lastname: Chen
authors.affiliation: Department of Cardiology, Jilin University the Second Hospital, Changchun, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Liu
authors.affiliation: Department of Cardiology, Affiliated Anzhen Hospital of Capital Medical University, Beijing, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Chen
authors.affiliation: Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China.
authors.forename: Zhanquan
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Cardiology, Shenyang Northern Hospital, Shenyang, China.
authors.forename: Yaling
authors.initials: Y
authors.lastname: Han
authors.affiliation: Department of Cardiology, Affiliated SRRS Hospital of Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: Guosheng
authors.initials: G
authors.lastname: Fu
authors.affiliation: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China.
authors.forename: Yelin
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Department of Cardiology, Affiliated Zhongshan Hospital of Fudan University, Shanghai, China.
authors.forename: Junbo
authors.initials: J
authors.lastname: Ge
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: in-stent restenosis; paclitaxel-coated balloon(s); paclitaxel-eluting stent(s)