Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global

Prior treatment

• Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g. aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, platinum, chromium, sirolimus, everolimus, radiographic contrast material) that cannot be adequately pre-medicated;
• Currently participating in another investigational drug or device study.
  • Angiographic Exclusion Criteria

Other illness

• Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
• Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy (DAPT) can be maintained throughout the peri-surgical period;
• Patient undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)
• Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months;

Lab values

• Acute or chronic renal dysfunction (creatinine \>3.0 mg/dl);

Age

• Patient is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, \< 2 years postmenopausal, or does not consistently use effective methods of contraception\*;

Other

• Clinical Exclusion Criteria
• Patient in cardiogenic shock;
• In-stent restenotic lesions;
• Lesions involving venous or arterial bypass grafts.

• Clinical Inclusion Criteria
• Patient understands the trial requirements and the treatment procedures and provides written informed consent;
• Age ≥ 18 years of age (\> 19 years of age for South Korea and ≥ 21 years of age for Singapore);
• Diabetic patient: either:
  • Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)
  • Newly diagnosed diabetes: either:
  • Fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for ≥8 hours1 or ii. Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test or iii. HbA1c level ≥ 7% (53 mmol/mol) Patients who are newly diagnosed are included even if they are not on pharmacological treatment (oral hypoglycemic agents or insulin)
• Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS)
• Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed \>12 months before index procedure;
• Patient is willing and able to comply with all protocol-required follow-up evaluations.
  • Angiographic Inclusion Criteria (visual estimate)
• Presence of ≥1 de novo coronary artery stenosis \>50% in a native coronary artery which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with 1 or multiple stents; and
• No limitation to the number of treated lesions, number of vessels, or lesion length if the patient is judged eligible for PCI by the treating physician according to the local standard of care.