Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Piedmont Heart Institute, Inc., Atlanta, GA
Saint Luke's Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 day survival following high risk percutaneous coronary revascularization who are at high risk. | 30 days | Patients will be followed with phone calls at 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only. | 12 months | Patients will be called at 12 months time by the centralized follow up center. |
Countries
United States
Outcome results
None listed