Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes

This registry study will be conducted in 56 centers in which Firebird 2 stent is implemented. The data of 1300 patients, in which only Fireibrd2 stent is implanted, will be collected. All inclusive patients should be definitely diagnosed type 2 DM, either before or during the present hospitalization and with complex coronary lesions. The diagnosis criteria is the World Health Organization(WHO) recommended criteria 1999 version. I.e., fasting blood glucose ≥7.0mmol/L，random blood glucose ≥11.1mmol/L，or OGTT 2h blood glucose ≥11.1mmol/L. Impaired fasting glucose (6.0mmol/L～7.0mmol/L) or Impaired glucose tolerance (oral glucose tolerance test(OGTT) 2h blood glucose 7.8mmol/L～11.1mmol/L) can not be enrolled. The stress-induced hyperglycemia of acute coronary syndrome is illegible.

Inclusion Criteria:

• Definitely diagnosed type 2 DM either before or during the current hospitalization and with complex coronary lesions
• The coronary lesion is complied with the definition of complex type. (defined by protocol)
• The investigator admitted patients which are suitable for implanting Firebird2 CoCr-alloyed Sirolimus-eluting stent(SES)
• Patient or his/ her legal supervisor are provided with informed consents.

Exclusion Criteria:

• Women during pregnancy and breast-feeding;
• ST-segment elevated MI occurred within 1 week;
• Graft lesion after the coronary artery bypass graft(CABG) operation;
• Patient with other brand of stent implanted;
• LVEF ≤ 35%;
• Renal insufficiency before operation (Serum creatinine ≥ 177umol/L)
• Impaired fasting glucose（6.0mmol/L～7.0mmol/L）or impaired glucose tolerance（OGTT 2h blood glucose 7.8mmol/L～11.1mmol/L）patient;
• Recent PCI within 6 months or previous intravascular radiotherapy;
• Predicted life span is less than 12 months;
• Patient allergic to the following materials: aspirin, heparin, Clopidogrel, CoCr alloy, contrast agent or sirolimus.
• Recent participation of trial medication or other device study without endpoints completion or it is clinically interfering FIRE2－DIABETES study endpoints.
• Considered by other investigators unsuitable for implanting Firebird2 CoCr-alloyed SES
• Patients could not obey the study rules, such as not understanding the study manner, scope or its outcome, not cooperative, not providing the informed consent, not accepting follow-up, not finishing the whole study procedure.