This revised application proposes to establish an Economics and Quality of Life Coordinating Center for the Open Artery Trial, (OAT), a multi-center, randomized trial of late (3-21 days) percutaneous revascularization versus standard medical therapy in 3200 asymptomatic high-risk acute myocardial infarction (MI) survivors and who are found at diagnostic catheterization to have an occluded infarct-related artery. All patients will receive standard medical therapy (including aspirin, beta blockers, ACE inhibitors). Qualifying patient will be randomized in equal proportions to either percutaneous revascularization of the occluded infarct related artery or medical therapy alone. Patients will be recruited into the trial over a 2 year period, with a subsequent minimum follow-up period of 2.25 years. The primary endpoint of the trial is a composite of all cause mortality, non-fatal MI and hospitalization for class IV heart failure. Cost, cost effectiveness and health-related quality of life are secondary endpoints. In collaboration with the Clinical Coordinating Center and the Statistical and Data Coordinating Center, the Economics and Quality of Life Coordinating Center will perform the following major functions: 1) obtain baseline economic status and quality of life data from all patients enrolled at each participating study site at the time of randomization; 2) collect detailed health resource consumption data from the index hospitalization; 3) assess detailed economic, functional status and quality of life outcomes during follow-up telephone contacts by study site coordinators at 4 months, 1 year and 2.25 years after enrollment; 4) assess angina- and heart failure-related functional status by telephone contacts every 4 months during study follow-up; 5) identify all major medical encounters that occur during follow-up and collect detailed health care resource consumption data and cost data for each; 5) compare cost and quality of life outcomes for the two treatment arms according to intention-to-treat; 7) estimate the incremental cost effectiveness ratio for the experimental arm and perform extensive sensitivity analyses. If efficacy is demonstrated for the primary study endpoint, then the economic and quality of life data collected as part of this proposal will clearly be pivotal in determining how the results of this study are viewed and whether the findings of the trial receive widespread implementation. We propose to use state-of-the-art methods for measuring cost and quality of life and for estimating cost effectiveness.
