The Bypass Angioplasty Revascularization Investigation (BARI) is a multicenter, randomized clinical trial assessing balloon angioplasty versus coronary surgery in patients with multivessel coronary disease. Angiography from 19 clinical sites is interpreted at a central radiographie laboratory (CRL) to ensure consistency and reproducibility.
Angiographie definitions were based on formats used in prior revascularization trials, particularly the Coronary Artery Surgery Study. New definitions and concepts were implemented that focus on assessing revascularization. The relative size of left ventricular myocardial territories is derived from the distribution of their coronary blood supply, which is subdivided into anterior, lateral, and inferoposterior regions. Based on 50% threshold for lesion severity, the amount of jeopardized left ventricular myocardium is estimated. Lesion severity is graded by a combination of continuous and categoric scales. Lesion suitability for angioplasty is assessed using a standard, three-level categorization. A distributed angio-acquisition computer collects data entered by clinical site angiographers. A duplicate system is used by CRL angiographers for primary analysis and adjudication of interpretive differences between clinical sites and the CRL.
Angiographie criteria are detailed that define coronary artery segmentation; left ventricular myocardial territories and distribution of coronary vessels; lesion identification, location, and severity assessment; lesion classification; distal flow through native vessels; collaterals and grafts; lesion importance and suitability for revascularization; post-percutaneous transluminal coronary angioplasty (PTCA) descriptors; and postcoronary graft surgery descriptors and categories of lesion change.
Criteria for defining multiple angiographie aspects of coronary disease, vessel distribution, PTCA, and coronary surgery are provided. An anatomically flexible, menu-driven, computer-assisted data entry system is used to provide convenient means for data acquisition. We believe the criteria used in BARI will be useful in other studies of coronary revascularization and in providing standardized nomenclature and definitions.
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