Triple vessel disease | Disease Proximal Left Anterior Descending Artery | Disease Mid-Left Anterior Descending Artery | Percent Diameter Stenosis Measurement Angiography | Site Quantity Analysis Visual | Requirement Myocardial Revascularization | Stenosis Limiting Blood flow
Item
triple-vessel disease with proximal or mid lad disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization or triple-vessel disease with proximal or mid lad disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
boolean
C0856738 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3640705 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C3640698 (UMLS CUI [3,2])
C3897965 (UMLS CUI [4,1])
C0002978 (UMLS CUI [4,2])
C1515974 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0936012 (UMLS CUI [5,3])
C0234621 (UMLS CUI [5,4])
C1514873 (UMLS CUI [6,1])
C0027056 (UMLS CUI [6,2])
C1261287 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0232338 (UMLS CUI [7,3])
Coronary Artery Disease Score
Item
total syntax score > 22
boolean
C1956346 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Circumflex branch of left coronary artery Requirement Revascularization | Right coronary artery Requirement Revascularization | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Therapy Vessel Major Quantity | Exception LAD
Item
lcx and rca territories estimated to be equivalently revascularized by either pci or cabg, with at least one major non-lad vessel to be treated
boolean
C1305727 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0581603 (UMLS CUI [1,3])
C0226042 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0581603 (UMLS CUI [2,3])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C0005847 (UMLS CUI [5,2])
C0205164 (UMLS CUI [5,3])
C1265611 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C1321506 (UMLS CUI [6,2])
Eligibility Percutaneous Coronary Intervention | Eligibility Coronary Artery Bypass Surgery
Item
clinical and anatomic eligibility for both pci and cabg as agreed to by both interventional and surgical consensus
boolean
C1548635 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0010055 (UMLS CUI [2,2])
Determination Appropriateness Percutaneous Coronary Intervention | Determination Eligibility Percutaneous Coronary Intervention
Item
interventionalist determines pci appropriateness and eligibility
boolean
C0521095 (UMLS CUI [1,1])
C0814634 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0521095 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
Determination Appropriateness Surgical | Determination Eligibility Surgical
Item
surgeon determines surgical appropriateness and eligibility
boolean
C0521095 (UMLS CUI [1,1])
C0814634 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0521095 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Silent myocardial ischemia | Stable angina | Angina, Unstable | Myocardial Infarction
Item
silent ischemia, stable angina, unstable angina or recent mi
boolean
C0340291 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Myocardial Infarction | Biomarkers Return to Normal
Item
if recent mi, cardiac biomarkers must have returned to normal prior to randomization
boolean
C0027051 (UMLS CUI [1])
C0005516 (UMLS CUI [2,1])
C0332156 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
Informed Consent | Protocol Compliance
Item
ability to sign informed consent and comply with all study procedures
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Percutaneous Coronary Intervention Previous | Coronary Artery Bypass Surgery Previous
Item
prior pci or cabg at any time prior to randomization
boolean
C1532338 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Patient need for Cardiac Surgery procedure | Exception Coronary Artery Bypass Surgery | Operative Surgical Procedures Valve | Aorta repair
Item
need for any concomitant cardiac surgery other than cabg (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated cabg will be performed
boolean
C0686904 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0010055 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1186983 (UMLS CUI [3,2])
C0190364 (UMLS CUI [4])
Antiplatelet therapy Dual Unable | Lacking Compliance behavior Antiplatelet therapy Dual
Item
patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
boolean
C1096021 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C1096021 (UMLS CUI [2,3])
C0205173 (UMLS CUI [2,4])
Requirement Cardiac Surgery procedure Additional | Requirement Operative Surgical Procedure Additional
Item
patients requiring additional surgery (cardiac or non cardiac) within one year
boolean
C1514873 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
Medical condition Percutaneous Coronary Intervention Unfavorable | Coronary Artery Bypass Surgery Recommended | Medical therapy Recommended
Item
the presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by pci, but rather should be managed with cabg or medical therapy - reasons will be documented)
boolean
C3843040 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0010055 (UMLS CUI [2,1])
C0034866 (UMLS CUI [2,2])
C0418981 (UMLS CUI [3,1])
C0034866 (UMLS CUI [3,2])
Medical condition Coronary Artery Bypass Surgery Unfavorable | Percutaneous Coronary Intervention Recommended | Medical therapy Recommended
Item
the presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by cabg, but rather should be managed with pci. or medical therapy - reasons will be documented)
boolean
C3843040 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C1532338 (UMLS CUI [2,1])
C0034866 (UMLS CUI [2,2])
C0418981 (UMLS CUI [3,1])
C0034866 (UMLS CUI [3,2])
Comorbidity | Exception Heart Disease | Life Expectancy
Item
non cardiac co-morbidities with life expectancy less than 1 year
boolean
C0009488 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Primary Endpoint failed
Item
other investigational drug or device studies that have not reached their primary endpoint.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2986535 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])