title: Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial.
abstract: OBJECTIVE
  This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions.
  
  
  RESULTS
  The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2™ stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11±0.18 mm vs. 0.14±0.23 mm, p=0.16; non-inferiority p<0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p>0.05, respectively).
  
  
  CONCLUSIONS
  The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355).
authors.affiliation: Fuwai Hospital, National Centre for Cardiovascular Diseases of China, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.forename: Kefei
authors.initials: K
authors.lastname: Dou
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Yang
authors.forename: Shuzheng
authors.initials: S
authors.lastname: Lv
authors.forename: Lefeng
authors.initials: L
authors.lastname: Wang
authors.forename: Haichang
authors.initials: H
authors.lastname: Wang
authors.forename: Zhanquan
authors.initials: Z
authors.lastname: Li
authors.forename: Lei
authors.initials: L
authors.lastname: Wang
authors.forename: Yundai
authors.initials: Y
authors.lastname: Chen
authors.forename: Yong
authors.initials: Y
authors.lastname: Huo
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.forename: Runlin
authors.initials: R
authors.lastname: Gao
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000704:Analysis of Variance; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D002681:China; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011091:Polyesters; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D002858:Chromium Alloys; D011091:Polyesters; C033616:poly(lactide); D020123:Sirolimus