title: Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus insight from the 4-year results of the create study.
abstract: BACKGROUND
  Diabetes mellitus is an independent predictor of adverse clinical events after drug-eluting stent implantation.
  
  
  OBJECTIVE
  The objective of this study is to evaluate the long-term clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in diabetic versus non-diabetic patients.
  
  
  METHODS
  A total of 2077 "all comers," including 440 (21.2%) diabetic patients and 1637 (78.8%) non-diabetic patients, were prospectively enrolled in the CREATE study at 59 centers in four countries. The recommended antiplatelet regimen was clopidogrel and aspirin for 6 months followed by chronic aspirin therapy. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), and target lesion revascularization (TLR).
  
  
  RESULTS
  Diabetic patients had higher risks of all-cause death (8.2% vs. 3.4%, P < 0.001) and cardiac death (4.1% vs. 1.4%, P < 0.001) compared with non-diabetic patients at 4 years. The rates of non-fatal MI (0.2% vs. 0.9%, P = 0.218), TLR (2.0% vs. 2.8%, P = 0.357), MACE (5.9% vs. 4.4%, P = 0.227), and overall stent thrombosis (1.6% vs. 1.6%, P = 0.932) were not significantly different between diabetic and non-diabetic patients. A landmark analysis showed that prolonged clopidogrel therapy (>6 months) was not beneficial in reducing the cumulative hazards of MACE either in diabetic or non-diabetic patients (log rank P = 0.810).
  
  
  CONCLUSIONS
  Biodegradable polymer-based sirolimus-eluting stents for the treatment of diabetic patients had a similar clinical event rate at 4 years compared with non-diabetic patients, except for a higher mortality rate.
authors.affiliation: Shenyang Northern Hospital, Shenyang, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Li
authors.forename: Yaling
authors.initials: Y
authors.lastname: Han
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.forename: Quanmin
authors.initials: Q
authors.lastname: Jing
authors.forename: Xiaozeng
authors.initials: X
authors.lastname: Wang
authors.forename: Gaoliang
authors.initials: G
authors.lastname: Yan
authors.forename: Yingyan
authors.initials: Y
authors.lastname: Ma
authors.forename: Geng
authors.initials: G
authors.lastname: Wang
authors.forename: Shouli
authors.initials: S
authors.lastname: Wang
authors.forename: Xuezhi
authors.initials: X
authors.lastname: Chen
authors.forename: Lixia
authors.initials: L
authors.lastname: Yang
authors.forename: Guoying
authors.initials: G
authors.lastname: Zhu
authors.forename: Huiliang
authors.initials: H
authors.lastname: Liu
authors.forename: Tieming
authors.initials: T
authors.lastname: Jiang
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003920:Diabetes Mellitus / Q000401:mortality; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011108:Polymers; 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