Outcomes of Surgically Ineligible Patients With Multivessel CAD

Objectives 1. Compare 30-day mortality and the composite of mortality and morbidity following
high-risk percutaneous coronary revascularization with predicted Society of Thoracic Surgeons
(STS) survival and morbidity in patients with severe multivessel or left main coronary artery
disease (CAD).

2. Compare the 12-month health status and clinical outcomes of surgically ineligible
multivessel or left main CAD patients treated with PCI compared to those treated with a
medical therapy alone.

3. Understand the association between completeness of revascularization and long-term health
status and clinical outcomes among patients with multivessel or left main CAD treated with
PCI deemed ineligible for surgery.

4. Compare 6-month and 1-year survival among surgically ineligible high-risk PCI patients
with predicted STS survival (ASCERT risk model)

5. Determine the justification for surgical ineligibility by cardiologists and cardiac
surgeons among patients with severe multivessel or left main coronary artery disease (CAD).

6. Describe the frequency and predictors of PCI versus medical management among surgically
ineligible patients with severe multivessel or left main CAD.

7. Describe the frequency and predictors of complete revascularization in this population.

8. Describe the costs and costs per quality adjusted life year (QALY) gained of the strategy
of management of multivessel or left main CAD with PCI versus medical therapy among
surgically ineligible patients.

Inclusion Criteria:

- Participant Selection Inclusion Criteria

1. Participant undergoes coronary angiography revealing unprotected left main stenosis of
> 50%, 3 vessel disease with stenoses > 70% or 2 vessel coronary disease (>70%) with
one lesion involving the proximal LAD. Patients will also be included if there is FFR
evidence of flow limiting stenosis (FFR ≤ 0.80) in the setting of > 40% angiographic
stenosis the left main, 3 epicardial coronaries or 2 vessels including the proximal
LAD. Patients with prior bypass surgery will be included if they have ≥ 2 epicardial
vascular distributions subtended by a severe native coronary stenosis with either no
bypass graft supplying the vessel, a severely diseased (>70% stenosis) bypass graft
supplying the affected vessel or an occluded bypass graft to the affected vessel.

2. Patient considered high risk for coronary artery bypass surgery and declared
ineligible for surgery by the heart team.

3. Patient is experiencing clinical symptoms consistent with obstructive coronary artery
disease or with evidence of coronary ischemia on non-invasive/invasive (FFR)
functional testing.

4. Subject is ≥ 18 years of age at the time of consent and is willing to sign an informed
consent document approved by the enrolling hospital's Institutional Review Board and
follow-up for 12-months following enrollment in the study

5. Patient is able to speak English.

Exclusion Criteria:

- Exclusion Criteria

1. Established iodine allergy that cannot be managed medically, allergy to
everolimus, or absolute contraindication to aspirin, P2Y12 antagonist therapy
with either clopidogrel, prasgurel, ticagrelor or ticlopidine or absolute
contraindication to bivalirudin and heparin precluding procedural
anticoagulation.

2. Emergent revascularization required for ST-elevation myocardial infarction or
cardiac arrest, or severe sustained hemodynamic instability.

3. Patients presenting late after STEMI (> 12 hours after symptom onset) for
"salvage" PCI.

4. Too hard of hearing to do follow-up by telephone.

5. Currently incarcerated.

6. Dementia.

7. Subjects with no way to be contacted by telephone for follow-up, including those
who live outside of the U.S. or spend significant time outside of the U.S.

8. Patients with conditions such as cancer, mental illness, or other pathology
which, in the opinion of the local investigator, might put the patient at risk,
preclude follow-up or confound the results of the study.

9. Patients who refuse.

10. Female subjects with a positive quantitative or qualitative pregnancy test will
not be enrolled.