title: Efficacy and safety of a biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCROSSAL) in treating de novo coronary artery disease: A pooled analysis of the CREDIT II and CREDIT III trials.
abstract: The safety and efficacy of the second-generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) in daily clinical practice remains unknown. Additionally, to meet the China Food and Drug Administration requirements, we conducted an objective performance criterion study from the CREDIT II and CREDIT III trials.
  
  
  
  CREDIT II was a randomized trial comparing the EXCEL2 versus EXCEL stent in patients with up to 2 de novo coronary lesions. CREDIT III was a prospective, single-arm study evaluating the efficacy and safety of EXCEL2 in broad types of de novo coronary artery lesions. This pooled analysis included patients in the CREDIT III and EXCEL2 arm of the CREDIT II trial. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinical indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed.
  
  
  
  A total of 833 patients were included, consisting of 625 in the CREDIT III trial and 208 in the EXCEL2 arm of the CREDIT II trial. Twelve-month TLF occurred in 6.1% patients, cardiac death in 0.4%, TV-MI in 5%, and CI-TLR in 1.1%. Additionally, 64 (7.7%) PoCE and 3 probable late stent thromboses (0.4%) were recorded.
  
  
  
  EXCEL2 stent met the objective performance criterion on efficacy and safety with a low level of 12-month TLF as well as stent thrombosis when treating patients with de novo coronary lesions. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Geng
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Heyang
authors.initials: H
authors.lastname: Wang
authors.affiliation: Department of Cardiology, Cardiovascular Institute and Fu Wai Hospital, Beijing, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.affiliation: Department of Cardiology, Cardiovascular Institute and Fu Wai Hospital, Beijing, China.
authors.forename: Yuejin
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Cardiology, The 2nd Affiliated Hospital of Shanxi Medical University, Taiyuan, China.
authors.forename: Zhiming
authors.initials: Z
authors.lastname: Yang
authors.affiliation: Department of Cardiology, Daqing Oilfield General Hospital, Daqing, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, China.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Department of Cardiology, Affiliated 1st Hospital of The Fourth Military Medical University, Xi'an, China.
authors.forename: Haichang
authors.initials: H
authors.lastname: Wang
authors.affiliation: Department of Cardiology, General Hospital of Chengdu Military Region, Kunming, China.
authors.forename: Lixia
authors.initials: L
authors.lastname: Yang
authors.affiliation: Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Yaling
authors.initials: Y
authors.lastname: Han
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020341:Absorbable Implants; D002317:Cardiovascular Agents / Q000008:administration & dosage / Q000009:adverse effects; D002681:China; D002858:Chromium Alloys; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D053208:Kaplan-Meier Estimate; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D011108:Polymers; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D002858:Chromium Alloys; D011108:Polymers; D020123:Sirolimus
keywords: biodegradable polymer; coronary artery disease; percutaneous coronary intervention; sirolimus-eluting stents