Outcomes of Surgically Ineligible Patients With Multivessel CAD
Outcomes of Surgically Ineligible Patients With Multivessel CAD
The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort
 design to follow patients who have multivessel or left main coronary artery disease
 ("surgical anatomy" according to ACC/AHA Appropriateness Criteria for PCI12) and are deemed
 ineligible for coronary artery bypass surgery. It is anticipated that 20 sites will be
 selected to participate in the registry from a national network of leading centers across the
 United States with recognized expertise in both complex PCI and coronary artery bypass
 surgery. We will invite leading cardiac centers, as defined by US News and World reports
 rankings for heart care. Additional sites may be added to meet the target enrollment goal.
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.