title: Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in "real-world" practice: three-year outcomes of the CREATE (Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents) study.
abstract: BACKGROUND
  The CREATE is a post-marketing surveillance multicenter registry that demonstrated satisfactory angiographic and clinical (at 18 months) outcomes of a biodegradable polymer based sirolimus-eluting stent (EXCEL, JW Medical System, Weihai, China) for the treatment of patients in routine clinical practice.
  
  
  OBJECTIVE
  To evaluate the three-year clinical safety and efficacy outcomes in patients enrolled in the CREATE study.
  
  
  METHODS
  A total of 2077 all comers have been enrolled in the CREATE study at 59 centers from four countries. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The prespecified primary outcome was the rate of major adverse cardiac events (MACE) at 12, 18, and 36 months.
  
  
  RESULTS
  Clinical follow-up was completed in 2025 (97.5%) patients at three years. The average duration of clopidogrel treatment was 199.8 ± 52.7 days and 80.5% of discharged patients discontinued clopidogrel at six months. The cumulative rate of MACE was 4.5% and the rate of stent thrombosis was 1.53% at three years. At six months to three years, prolonged clopidogrel therapy (>6 months) was not beneficial in reducing cumulative hazards of MACE (3.4% vs. 3.1%, log rank P = 0.725) or stent thrombosis (1.5% vs. 0.6%, log rank P = 0.053).
  
  
  CONCLUSIONS
  This study demonstrates sustained three-year clinical safety and efficacy of biodegradable polymer-based sirolimus-eluting stents when used with six months of dual antiplatelet therapy in a "real-world" setting.
authors.affiliation: Department of Cardiology, Shenyang Northern Hospital, Shenyang, China. hanyaling.nh@gmail.com
authors.forename: Yaling
authors.initials: Y
authors.lastname: Han
authors.forename: Quanmin
authors.initials: Q
authors.lastname: Jing
authors.forename: Yi
authors.initials: Y
authors.lastname: Li
authors.forename: Lixia
authors.initials: L
authors.lastname: Yang
authors.forename: Huiliang
authors.initials: H
authors.lastname: Liu
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Shang
authors.forename: Tiemin
authors.initials: T
authors.lastname: Jiang
authors.forename: Zhanquan
authors.initials: Z
authors.lastname: Li
authors.forename: Hua
authors.initials: H
authors.lastname: Zhang
authors.forename: Gaoliang
authors.initials: G
authors.lastname: Yan
mesh_terms: D020341:Absorbable Implants; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000494:pharmacology*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D020123:Sirolimus