Investigators revealed Jan. 30 that partial results of the world's largest observational study of long-term survival in patients undergoing CABG surgery procedures compared with patients undergoing coronary stent placement by PCI, according to a study presented at the 48th annual meeting of the Society of Thoracic Surgeons (STS).
In the STS presentation, it was decided to focus entirely on the high-risk clinical subgroups, in whom, a progressively higher long-term survival advantage for CABG patients compared with PCI patients was shown.
Overall results of the trial will be presented at the late breaking clinical trials session at the American College of Cardiology's (ACC) 61st Annual Scientific Session & Expo in Chicago in March.
Funded by the National Institutes of Health (NIH), the ASCERT [ACC-STS Database Collaboration on the Comparative Effectiveness of Revascularization Strategies] study is a trial that used the clinical databases of both STS and ACC. To obtain long-term follow up, patient records also were linked to data from the Centers for Medicare & Medicaid Services (CMS).
ASCERT researchers assessed more than 185,000 Medicare patients undergoing heart revascularization from 2004 to 2008.
In the high-risk patient subsets presented at the STS meeting, first year survival favored stent placement. However, beyond the first year of revascularization, these subgroups showed a CABG survival advantage that progressively increased over time.
"The focus of the ASCERT study was on 'real-world' patients," said Fred H. Edwards, MD, current head of the STS Research Center and ASCERT co-principal investigator. "Previous observational studies have shown a long-term survival advantage for CABG over PCI. These partial ASCERT results confirm that in important high-risk clinical subsets the CABG survival advantage can also be seen in a large nationwide population." William S. Weintraub, MD, chief of cardiology at Christiana Care Health System in Wilmington, Del., is the co-principal investigator.
"By linking the two clinical registry patient records with the longitudinal CMS claims data, ASCERT offers patients and physicians a comprehensive look at the comparative effectiveness of open heart surgery and stent procedures," said Edwards, from the division of cardiothoracic surgery at the Shands Jacksonville Medical Center in Jacksonville, Fla. "The results of this subset study and our forthcoming report of the overall ASCERT population, to be presented at ACC's Scientific Session in March, should be used to improve the quality of care for heart patients."
The CABG population for ASCERT was taken from the STS Adult Cardiac Surgery Database, which currently contains more than 4.5 million surgical records and represents an estimated 94 percent of all adult cardiac surgery centers across the U.S. The PCI population for ASCERT was taken from ACC's National Cardiovascular Data Registry, an outcomes-based quality improvement U.S. program representing more than 10.6 million patient records.
The funding for the ASCERT study was issued under the American Recovery and Reinvestment Act of 2009. This is the first time STS and ACC have collaborated in an NIH study.
Edwards and David M. Shahian, MD, chair of the STS Workforce on national databases, presented the findings of the ASCERT trial at STS12.