Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions

Inclusion criteria

• The patient must be minimum 18 years of age;
• Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
• Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;
• Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
• The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
• The target lesion is <30 mm in length (visual estimate) located in a native coronary artery;
• Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);

Exclusion criteria

• Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
• Patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (Brittle Diabetics);
• Ejection fraction 30%;
• Impaired renal function (creatinine > 2.0 mg/dL);