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.
Study Type
OBSERVATIONAL
Enrollment
750
Banner University Medical Center
Phoenix, Arizona, United States
Unifersity of California San Diego Medical Center
San Diego, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 11 more locations
30 day survival following high risk percutaneous coronary revascularization who are at high risk.
Patients will be followed with phone calls at 30 days.
Time frame: 30 days
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.
Time frame: 12 months
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