The National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) has awarded a grant to the American College of Cardiology (ACC) in partnership with The Society of Thoracic Surgeons (STS) to study the comparative effectiveness of the two forms of coronary revascularization; percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery. This study will compare catheter-based and surgery-based procedures using existing databases from the ACC and STS, as well as the Centers for Medicare and Medicaid Services’ MEDPAR data. By linking these three databases, the study will help physicians make better decisions and improve healthcare for patients with coronary artery disease.
Dr. William Weintraub, principal investigator on the study and chair of the ACC’s National Cardiovascular Data Registry (NCDR) CathPCI Registry Steering Committee said, “There remains considerable uncertainty about the best strategy between catheter-based and surgery-based approaches in patients requiring revascularization for coronary artery disease. This collaboration between the ACC and STS will allow us to address this vital question. By having available to us combined databases of over 10 million people, we will also be able to address concerns about choice in critical subgroups such as patients with other severe diseases and the elderly. This grant will offer a model for how to pursue comparative effectiveness research using large clinical databases."
The study will set a standard for combining clinical databases with administrative databases to study comparative effectiveness of therapies in large patient populations as well as help to inform shared decision making between physicians and patients about the best approach for their treatment. The approach used in this project can be adopted by other specialties and their professional societies for comparative effectiveness studies and quality improvement initiatives, and the techniques of analysis should have broad application to the entire field of medicine.
“This has potential to be a significant study, given the focus of the research (PCI vs. CABG), use of the two most prominent clinical registries in the country, and the fact that collaboration between STS and ACC covers the entire spectrum of adult cardiovascular disease. To my knowledge there is no other research that has approached the scope of this project,” said Dr. Fred H. Edwards, also principal investigator on the study and chair of the STS Workforce on National Databases.
This is a joint project of the ACC and STS. 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. In addition, PERFUSE Angiographic Core Laboratories and Data Coordination Center will be performing detailed angiographic analysis on 2,000 angiograms of patients undergoing PCI in order to determine their SYNTAX score. Led by Drs. Weintraub and Edwards, a steering committee of investigators representing ACC, STS, DCRI, CCOR and PERFUSE will be responsible for the administration and conduct of this study. This award has been issued under the American Recovery and Reinvestment Act of 2009 and is in the amount of $4,026,764 over the two year period of the study.