Coronary artery disease (CAD) is a major cause of morbidity and mortality in the United States. Despite being researched extensively, there remain questions regarding the comparative effectiveness of the two forms of coronary revascularization therapy, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery. This study will compare these two procedures using existing databases from the American College of Cardiology Foundation (ACCF) and The Society of Thoracic Surgeons (STS), as well as the Centers for Medicare and Medicaid Services MEDPAR data. By linking these three databases, the study will compare CABG and PCI in order to better understand the procedures, help physicians make better treatment decisions, and improve care for patients with CAD.
The aims of the study are to: 1) Create separate PCI and CABG prediction models of death and non-fatal events long-term after initial revascularization in the setting of chronic coronary artery disease. 2) Characterize patients undergoing CABG vs. PCI by developing propensity scores for CABG in patients undergoing isolated CABG or PCI not in the setting of an acute myocardial infarction. Describe these patients in both groups across the range of their propensity scores. 3) Compare long-term survival, hospitalization for MI, renal failure, stroke and repeat revascularization using propensity score methods. 4) Select a random sample of patients undergoing CABG or PCI for detailed angiographic analysis to create a SYNTAX score. In this sample, attempt to model the SYNTAX score based on covariates available in the STS and ACC Databases. Use these data to consider the presence of residual confounding based on angiographic severity defined by the SYNTAX score. 5) Assess long-term outcomes by age, gender, co-morbidity, and severity of disease. 6) Assess resource use and long-term costs in each group using MEDPAR. The cost and incremental cost-effectiveness of CABG compared to PCI will be considered for the whole matched group and for subgroups as defined above. The outcome will be in cost per life year gained and cost per quality adjusted life year gained. This is a joint project of the STS and the ACCF. Duke Clinical Research Institute (DCRI) will perform the analysis for clinical outcomes and Christiana Care Center for Outcomes Research (CCOR) will perform the analysis for economic outcomes. A steering committee of investigators representing each institution will be responsible for the design, conduct, and reporting of the study. Because ACC and STS cover virtually all of cardiovascular medicine, the approach used in this project can be adopted by other specialties and their professional societies for comparative effectiveness studies and quality improvement initiatives. The techniques of analysis used in this project should have broad application to the entire field of medicine. 1
By linking three national patient record databases, this study will compare coronary artery bypass graft surgery and percutaneous coronary intervention in order to better understand the procedures and improve healthcare for patients with coronary artery disease, one of the major causes of morbidity and mortality in the United States. Such linked data will contain process, risk-adjusted outcomes, utilization, and cost data spanning several years that has a potentially great benefit to society. Specifically, this study will permit a direct comparative effectiveness study of CABG vs. PCI that is more comprehensive than any currently available, and will be of inestimable benefit in provider decision-making and patient counseling in a variety of clinical situations.
