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The Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients With Multivessel or
Adam C Salisbury1, Ajay J Kirtane2, Ziad A Ali2
1Saint Luke's Mid America Heart Institute, Kansas City, MO, United States of America; University of Missouri-Kansas City, Kansas City, MO, United States of America.
Insights
The OPTIMUM registry is the first prospective study on high-risk patients with complex coronary artery disease (CAD) ineligible for bypass surgery. It examines percutaneous coronary intervention (PCI) use, outcomes, and patient health status.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- Coronary artery bypass grafting (CABG) is recommended for left main and/or multivessel coronary artery disease (CAD).
- A significant number of patients are deemed too high-risk for CABG by Heart Teams.
- Lack of prospective data on contemporary treatment and outcomes for surgically ineligible high-risk CAD patients.
Purpose of the Study:
- To prospectively evaluate treatment patterns and outcomes in high-risk patients with advanced CAD unsuitable for CABG.
- To assess the safety and effectiveness of percutaneous coronary intervention (PCI) in this population.
- To analyze factors influencing surgical risk determination and the impact of revascularization completeness on outcomes.
Main Methods:
- The Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease (OPTIMUM) registry is a prospective, multicenter study.
- It includes patients with "surgical anatomy" at prohibitive risk for bypass surgery.
- Primary outcome: observed vs. predicted 30-day mortality; Secondary outcomes: patient-reported health status, completeness of revascularization, and clinical outcomes.
Main Results:
- The registry will report patient characteristics driving surgical risk assessment.
- Peri-operative risk will be evaluated using validated scoring methods.
- Angiograms and clinical events will be independently assessed and adjudicated.
Conclusions:
- OPTIMUM is the first prospective, multicenter study on treatment strategies and outcomes for multivessel CAD patients ineligible for surgical revascularization.
- The registry will offer unique insights into clinical decision-making, revascularization practices, safety, effectiveness, and health status in this high-risk group.
Background:
Guidelines endorse coronary artery bypass as the preferred revascularization strategy for patients with left main and/or multivessel coronary artery disease (CAD). However, many patients are deemed excessively high risk for surgery after Heart Team evaluation. No prospective studies have examined contemporary treatment patterns, rationale for surgical decision-making, completeness of revascularization with percutaneous coronary intervention (PCI), and outcomes in this high-risk population with advanced CAD.
Methods:
We designed the Outcomes of Percutaneous RevascularizaTIon for Management of SUrgically Ineligible Patients with Multivessel or Left Main Coronary Artery Disease (OPTIMUM) registry, a prospective, multicenter study of patients with "surgical anatomy" determined to be at prohibitive risk for bypass surgery. The primary outcome is comparison of observed to predicted 30-day mortality, with secondary outcomes of patient-reported health status and the association between completeness of revascularization and clinical outcomes. Patient characteristics driving surgical risk determinations will be reported, and peri-operative risk will be assessed using validated scoring methods. Angiograms will be assessed by an independent core laboratory, and clinical events will be adjudicated.
Results:
Clinical outcomes assessments will include 30-day and 1-year cardiovascular events, health status at 1, 6 and 12-months, and 5-year mortality.
Conclusions:
OPTIMUM is the first prospective, multicenter study to examine treatment strategies and outcomes among multivessel CAD patients deemed ineligible for surgical revascularization after Heart Team assessment. This registry will provide unique insights into the clinical decision-making, revascularization practices, safety, effectiveness, and health status outcomes in this high-risk population.
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