title: A new generation of biodegradable polymer-coated sirolimus-eluting stents for the treatment of coronary artery disease: final 5-year clinical outcomes from the CREATE study.
abstract: OBJECTIVE
  The aim of the present study was to evaluate the five-year safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent with six months dual antiplatelet therapy in daily practice.
  
  
  RESULTS
  Two thousand and seventy-seven daily practice patients, exclusively treated with biodegradable polymer-coated sirolimus-eluting stents (EXCEL; JW Medical Systems, Weihai, China), were prospectively enrolled in the multicentre CREATE study. Clinical follow-up was completed in 1,982 patients (95.4%) at five-year follow-up. The rates of cardiac death, non-fatal myocardial infarction (MI), target lesion revascularisation and overall major adverse cardiac events (MACE) at five-year follow-up were 3.0%, 1.5%, 3.7% and 7.4%, respectively. The rates of definite or probable stent thrombosis (ST) at five years and definite ST from one to five years were 1.1% and 0.3%, respectively. Heart failure (hazard ratio [HR]: 3.324, 95% confidence interval [CI]: 1.729-6.391, p<0.001) and prior MI (HR: 2.664, 95% CI: 1.358-5.227, p=0.004) were independent predictors of ST. Landmark analysis of a propensity score matched patient cohort showed that patients with or without clopidogrel treatment after six months had similar clinical outcomes.
  
  
  CONCLUSIONS
  The present study demonstrates satisfactory and sustained five-year clinical safety and efficacy profiles as evidenced by the low rates of MACE and ST for the EXCEL, a biodegradable polymer-based sirolimus-eluting stent, when patients were treated with six months dual antiplatelet therapy in daily practice.
authors.affiliation: Department of Cardiology, Shenyang Northern Hospital, Shenyang, 110840 China. hanyaling.nh@gmail.com
authors.forename: Ya-Ling
authors.initials: YL
authors.lastname: Han
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.forename: Li-Xia
authors.initials: LX
authors.lastname: Yang
authors.forename: Hui-Liang
authors.initials: HL
authors.lastname: Liu
authors.forename: Peng
authors.initials: P
authors.lastname: Qu
authors.forename: Wei-Min
authors.initials: WM
authors.lastname: Li
authors.forename: Tie-Min
authors.initials: TM
authors.lastname: Jiang
authors.forename: Shu-Mei
authors.initials: SM
authors.lastname: Li
authors.forename: Quan-Min
authors.initials: QM
authors.lastname: Jing
authors.forename: Quan-Yu
authors.initials: QY
authors.lastname: Zhang
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.forename: Yi
authors.initials: Y
authors.lastname: Li
authors.forename: Run-Lin
authors.initials: RL
authors.lastname: Gao
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006333:Heart Failure / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011108:Polymers; D057216:Propensity Score; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus