XIENCE 28 USA Study

The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE
implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be
registered from approximately 50 sites in the United States and Canada. Subject registration
is capped at 75 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be
assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat
coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1
month (prior to 1-month visit but at least 28 days) after stenting AND have been compliant
with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for
> 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor
inhibitor as early as 28 days and continued with aspirin monotherapy through 12-month
follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The
data collected from the XIENCE 28 USA Study will be pooled with the data from the XIENCE 28
Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex
HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA
Study.

Inclusion Criteria:

1. 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 > 1-month DAPT outweighs the
benefit:

1. ≥ 75 years of age.

2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation
therapy

3. History of major bleeding which required medical attention within 12 months of
the index procedure.

4. History of stroke (ischemic or hemorrhagic).

5. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).

6. 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/mm3, or any known coagulation disorder
associated with increased bleeding risk).

7. Anemia with hemoglobin < 11g/dl.

2. Subject must be at least 18 years of age.

3. Subject must provide written informed consent as approved by the Institutional Review
Board (IRB) of the respective clinical site prior to any trial related procedure.

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

5. Subject must agree not to participate in any other clinical trial for a period of one
year following the index procedure, except for cases where subject is transferred to
the XIENCE 90 study after the 1-month visit assessment

Angiographic Inclusion Criteria

1. 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.

2. Target lesion must be located in a native coronary artery with visually estimated
reference vessel diameter between 2.25 mm and 4.25 mm.

3. Exclusive use of XIENCE family of stent systems during the index procedure.

4. Target lesion has been treated successfully, which is defined as achievement of a
final in-stent residual diameter stenosis of <20% with final TIMI-3 flow assessed by
online quantitative angiography or visual estimation, with no residual dissection
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.

Exclusion Criteria:

1. Subject with an indication for the index procedure of acute ST-segment elevation MI
(STEMI).

2. 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.

3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12
months prior to index procedure.

4. Subject has a known left ventricular ejection fraction (LVEF) <30%.

5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor
use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.

6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12
inhibitor within 1 month following index procedure.

7. Subject with a current medical condition with a life expectancy of less than 12
months.

8. Subject intends to participate in an investigational drug or device trial within 12
months following the index procedure. Transferring to the XIENCE 90 study will not be
an exclusion criterion.

9. 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.

10. Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results.

11. Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint.

Angiographic Exclusion Criteria

1. Target lesion is in a left main location.

2. Target lesion is located within an arterial or saphenous vein graft.

3. Target lesion is restenotic from a previous stent implantation.

4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0
for at least 3 months).

5. Target lesion is implanted with overlapping stents, whether planned or for bailout.