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

ABILITY Diabetes Global

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the treatment of de novo coronary artery disease in patients with diabetes mellitus. ABILITY is a prospective, multi-center, multinational, randomized, open label, 2-arm parallel group, post-approval study.

Inclusion Criteria:

Clinical Inclusion Criteria

1. Patient understands the trial requirements and the treatment procedures and provides written informed consent;

2. Age ≥ 18 years of age (> 19 years of age for South Korea and ≥ 21 years of age for Singapore);

3. Diabetic patient: either:

   1. Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)
   2. Newly diagnosed diabetes: either:

   i. 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)

4. Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

5. Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed >12 months before index procedure;

6. Patient is willing and able to comply with all protocol-required follow-up evaluations.

   Angiographic Inclusion Criteria (visual estimate)

7. 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

8. 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.

Exclusion Criteria:

Clinical Exclusion Criteria

1. Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent

2. Patient in cardiogenic shock;

3. 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;

4. 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;

5. Patient undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)

6. 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*;

7. 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;

8. Acute or chronic renal dysfunction (creatinine >3.0 mg/dl);

9. Currently participating in another investigational drug or device study.

   Angiographic Exclusion Criteria

10. In-stent restenotic lesions;

11. Lesions involving venous or arterial bypass grafts.