XIENCE 28 Global Study

• Subject is considered at 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 \> 1-month DAPT outweighs the benefit:

‣ Subjects ≥ 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 \<100,000/mm\^3, or any known coagulation disorder associated with increased bleeding risk).

⁃ Anemia with hemoglobin \< 11g/dl.

• Subject must be at least 18 years of age.

• Subject must provide written informed consent as approved by the Ethics Committee (EC) of the respective clinical site prior to any trial related procedure.

• Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.

• Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.

∙ Angiographic Inclusion Criteria

• Up to three target lesions with a maximum of two target lesions per epicardial vessel.

• Note:

⁃ The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have \>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 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 \<20% with final thrombolysis in myocardial infarction (TIMI-3) flow assessed by online quantitative angiography or visual estimation, with no residual dissection National Heart, Lung, and Blood Institute (NHLBI) grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting \> 5 minutes, and no ST segment elevation \> 0.5mm or depression lasting \> 5 minutes.