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| Name | Class |
|---|---|
| Piedmont Heart Institute, Inc., Atlanta, GA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guideline Directed Medical Therapy | Patients who have an initial treatment strategy of using guideline-directed medical therapy only. | ||
| Percutaneous Coronary Intervention | Patients who will have a Percutaneous Coronary Intervention as the initial treatment strategy along with guideline directed medical therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 30 day survival following high risk percutaneous coronary revascularization who are at high risk. | Patients will be followed with phone calls at 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 12 month Seattle Angina Questionnaire Overall summary score comparing patients undergoing PCI versus those treated with medical therapy only. | Patients will be called at 12 months time by the centralized follow up center. | 12 months |
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Inclusion Criteria:
- Participant Selection Inclusion Criteria
Exclusion Criteria:
Exclusion Criteria
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Patients identified as having Coronary Artery Disease with Left Main or multivessel involvement, who have been deemed ineligible to receive coronary bypass surgery as treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Adam C Salisbury, MD MSc | Saint Luke's Health System | Principal Investigator |
| David E Kandzari, MD | Piedmont Heart and Vascular Institute | Principal Investigator |
| James A Grantham, MD | Saint Luke's Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Unifersity of California San Diego Medical Center |
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| San Diego |
| California |
| 92037 |
| United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30606 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University in Saint Louis | St Louis | Missouri | 63110 | United States |
| Northwell Health System | Manhasset | New York | 11030 | United States |
| Columiba University Medical Center | New York | New York | 10032 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Geisinger Health System | Danville | Pennsylvania | 17822 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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