title: A randomized comparison of novel biodegradable polymer- and durable polymer-coated cobalt-chromium sirolimus-eluting stents.
abstract: OBJECTIVE
  The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES.
  
  
  BACKGROUND
  No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type.
  
  
  METHODS
  In this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis.
  
  
  RESULTS
  At 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: -1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55).
  
  
  CONCLUSIONS
  In this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381).
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, China. Electronic address: hanyaling@263.net.
authors.forename: Yaling
authors.initials: Y
authors.lastname: Han
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Quanmin
authors.initials: Q
authors.lastname: Jing
authors.affiliation: Affiliated Anzhen Hospital of Capital Medical University, Beijing, China.
authors.forename: Shuzheng
authors.initials: S
authors.lastname: Lu
authors.affiliation: Kunming General Hospital of Chengdu Military Region, Kunming, China.
authors.forename: Lixia
authors.initials: L
authors.lastname: Yang
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Xu
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Li
authors.affiliation: General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Changdong
authors.initials: C
authors.lastname: Guan
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Yang
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D002858:Chromium Alloys; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D002858:Chromium Alloys; D011108:Polymers; D020123:Sirolimus
keywords: biodegradable polymer; clinical outcome; drug-eluting stent; durable polymer; noninferiority trial