Very Large Observational Study Finds Significant Mortality Advantage for CABG Over PCI in High Risk Patients Reply

Although PCI has a small, early mortality benefit compared to CABG in high risk patients, after the first year a striking survival advantage for CABG develops, according to results of the ASCERT study, presented on Monday at the annual meeting of the Society of Thoracic Surgeons (STS) meeting.

Fred Edwards presented the high-risk subset of ASCERT (ACCF-STS Database Collaboration on the Comparative Effectiveness of Revascularization Strategies), an NHLBI-funded study based on linked data from the STS, the ACC, and CMS administrative data. (The full results of ASCERT will be presented in March at the ACC scientific sessions.) The study population included patients 65 or older with 2 or 3 vessel disease who underwent CABG or PCI in the period from 2004 through 2007. 189,793 patients were followed in the study; 103,549 received PCI and 86,244 underwent CABG.

At 4 years there was a 22% risk reduction in adjusted mortality in the CABG group compared to the PCI group (RR = 0.78, CI 0.74-0.82). A similar pattern was observed in patients regardless of age, gender, diabetes status, and ejection fraction.

“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,” said Edwards in an STS press release.

Here is the press release from the Society of Thoracic Surgeons:

The World’s Largest Observational Study of CABG v. PCI Reveals Survival Advantage in Key Clinical Populations

FT. LAUDERDALE, FL, Jan. 30, 2011 – Today, at The Society of Thoracic Surgeons (STS) 48th Annual Meeting <http://www.sts.org/education-meetings/sts-annual-meeting> , investigators revealed partial results of the world’s largest observational study of long-term survival in patients undergoing heart bypass surgery (CABG) compared to patients undergoing coronary stent placement by percutaneous coronary intervention  percutaneous (PCI). In the STS presentation, it was decided to focus entirely on the high-risk clinical subgroups. For these subsets, a progressively higher long-term survival advantage for CABG patients compared to 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 <http://accscientificsession.cardiosource.org/ACC12.aspx>  in Chicago, IL in March.

Funded by the National Institutes of Health (NIH) <http://www.nih.gov/> , the ACCF-STS Database Collaboration on the Comparative Effectiveness of Revascularization Strategies (ASCERT) study is an unprecedented study that used the clinical databases of both The Society of Thoracic Surgeons and the American College of Cardiology (ACC). In order to obtain long-term follow up, patient records were also linked to data from the Centers for Medicare and Medicaid Services (CMS) <http://www.cms.gov/> .

ASCERT looked at over 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 an ASCERT 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,” said Dr. Edwards.

“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. 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.” concluded Dr. Edwards.

The CABG population for ASCERT was taken from the STS Adult Cardiac Surgery Database, the country’s premier clinical database that currently contains more than 4.5 million surgical records and represents an estimated 94 percent of all adult cardiac surgery centers across the United States.

The PCI population for ASCERT was taken from ACC’s National Cardiovascular Data Registry, the most comprehensive, outcomes-based quality improvement program in the United States representing over 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.

ASCERT Principal Investigators are Fred H. Edwards, MD and William S. Weintraub, MD.

The ASCERT TRIAL UPDATE will take place at 2pm EST at the 48th Annual STS Meeting in the Grand Floridian Ballroom A at the Broward County Convention Center.

Fred H. Edwards, MD, head of the STS Research Center and ASCERT principal investigator, and David M. Shahian, Chair of the STS Workforce on National Databases, will both present.

·         Dr. Edwards will present the differences in long-term survival between CABG and PCI in the high-risk subgroups.

·         Dr. Shahian will present how the ASCERT population was used to develop a new STS statistical model of CABG long-term survival.

Note to Editors: For more information about the ASCERT study, including study abstract or presentation slides, or to arrange for an interview with Dr. Edwards, either ON SITE at the STS Annual Meeting or via phone, contact Rachel Estrada atrestrada@sts.org <mailto:restrada@sts.org>   or by cellphone at (202) 531-5788. After Feb. 2nd, please contact (312) 202-5865.

Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 6,300 surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. The mission of the Society is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy. Learn more at www.sts.org .

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