XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.

Inclusion Criteria

• Subject is considered at high risk for bleeding (HBR), defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 3-month DAPT outweighs the benefit:
• ≥ 75 years of age.
• Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy.
• History of major bleeding which required medical attention within 12 months of the index procedure.
• History of stroke (ischemic or hemorrhagic).
• Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
• Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count 2 lesions requiring treatment within both the LAD and a diagonal branch in total.
• If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
• Target lesion ≤ 32 mm in length by visual estimation.
• Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
• Exclusive use of XIENCE family of stent systems during the index procedure.
• Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of 5 minutes, and no ST segment elevation > 0.5 mm or depression lasting > 5 minutes.

General Exclusion Criteria

• Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
• Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Subject with implantation of another drug-eluting stent (other than XIENCE) within 9 months prior to index procedure.
• Subject has a known left ventricular ejection fraction (LVEF) <30%.
• Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use.
• Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure.
• Subject with a current medical condition with a life expectancy of less than 12 months.
• Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Note: Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the study design, product characteristics and/or study population

• Subject is part of a vulnerable population, defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: individuals with lack of or loss of autonomy due to immaturity