title: Two-year results and subgroup analyses of the PEPCAD China in-stent restenosis trial: A prospective, multicenter, randomized trial for the treatment of drug-eluting stent in-stent restenosis.
abstract: BACKGROUND
  The PEPCAD China ISR trial investigated the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).
  
  
  METHODS
  A total of 220 patients with coronary DES-ISR were treated with PCB angioplasty or with paclitaxel-eluting stents (PES). This randomized (1:1), single-blind prospective multicenter trial in a Chinese population used 9-month in-segment late lumen loss (LLL) as the primary endpoint. Secondary endpoints included the 24-month clinical event rates.
  
  
  RESULTS
  Both treatment groups were similar in terms of patient, lesion, or procedural characteristics. After the 12-month follow-up evaluation, additional clinical events only occurred in the PES study group. The combined rate of all-cause mortality and myocardial infarction (MI) in the PCB group was significantly lower than that in the PES group (3.7% vs. 11.8%, P = 0.03). Additional subgroup analyses of 9-month in-segment LLL and 2-year target lesion failure in patients with diabetes, small vessels, diffuse ISR, and stent margin restenosis did not show more favorable results for one specific treatment group.
  
  
  CONCLUSIONS
  The 2-year follow-up demonstrated sustained long-term clinical efficacy for both devices. PCB angioplasty was associated with significantly lower overall and cardiovascular mortality/MI rates in patients with DES-ISR lesions while avoiding the use of additional metal layers for drug release (ClinicalTrials.gov identifier: NCT 01622075).
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Qian
authors.affiliation: Affiliated Zhongshan Hospital of Fudan University, Shanghai, China.
authors.forename: Junbo
authors.initials: J
authors.lastname: Ge
authors.affiliation: The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: Jian'an
authors.initials: J
authors.lastname: Wang
authors.affiliation: Affiliated Anzhen Hospital of Capital Medical University, Beijing, China.
authors.forename: Fang
authors.initials: F
authors.lastname: Chen
authors.affiliation: Guangdong General Hospital, Guangzhou, China.
authors.forename: Jiyan
authors.initials: J
authors.lastname: Chen
authors.affiliation: Shanghai Sixth People's Hospital, Shanghai, China.
authors.forename: Meng
authors.initials: M
authors.lastname: Wei
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: Yundai
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Runlin
authors.initials: R
authors.lastname: Gao
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: drug-eluting stent; in-stent restenosis; paclitaxel-coated balloon; paclitaxel-eluting stents