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Angiographic Validation of the American College of Cardiology Foundation-The Society of Thoracic Surgeons Collaboration Angiographic Validation of the American College of Cardiology Foundation-The Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies (ASCERT) Study Poster Title Anjan K. Chakrabarti, M. D. ; Maria V Grau-Sepulveda, M. D. , M. P. H. ; Sean O’ Brien, Ph. D. ; Cassandra Abueg, M. P. H. ; Angelo Ponirakis, Ph. D. ; Elizabeth Delong, Ph. D. ; Eric Peterson, M. D. ; Kirk N. Garratt, M. Sc. , M. D. ; William S. Weintraub, M. D. ; C. Michael Gibson, M. S. , M. D. *From the Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (AC, CMG); PERFUSE Angiographic Core Laboratories and Data Coordinating Center, Beth Israel Deaconess Medical Center, Boston, MA (AC, CA, CMG); Duke Clinical Research Institute, Duke University, Durham, NC (MVG-S, SO, ED, EP); American College of Cardiology, Washington, DC (AP); Northshore-LIJ/Lenox Hill Hospital, New York, NY (KG); Christiana Care Health System (WSW) ABSTRACT Disclosures: The primary author has no conflicts of interest to disclose. Dr. Peterson has received consulting fees and honoraria from Janssen, Genentech, Boehringer Ingelheim as well as research grants from Eli Lilly, Janssen. Dr. . Weintraub has received consulting fees and honoraria from Eli Lilly, Bristol Myers Squibb, Pfizer, and Amarin. Dr. Gibson has received consulting fees and honoraria from Johnson & Johnson Corp. , Bayer Corporation, Ischemix, Inc. , BCRI, Sanofi-Aventis Corp. , Genentech, Inc. , Merck & Co. , CSL Behring, Biogen Idec, Daiichi Sankyo, Inc. , Bristol Meyer Squibb, The Medicines Company, Janssen Pharmaceuticals, Inc, Regado Biosciences, Inc. , St. Jude Medical Corp. , Ortho Mc. Neil, Portola Pharmaceuticals, Eli Lilly and Company, and Glaxo. Smith. Kline, as well as research grants from Lantheus Medical Imaging, Janssen Pharmaceuticals, Inc, Bayer Corporation, Genentech Inc. , Merck & Co. , Atrium Medical Systems, Roche Diagnostics, Ikaria, Inc. , Portola Pharmaceuticals, Johnson & Johnson Corp. , Angel Medical Corporation, Volcano Corp. , Stealth Peptides, Sanofi-Aventis, Walk Vascular , and St. Jude's Medical, as well as other financial support from Up. To. Date in Cardiovascular Medicine. All other co-authors have no conflicts to disclose. METHODS • Background: The goal of this study was to compare angiographic interpretation of coronary arteriograms by sites in community practice versus those made by a centralized angiographic core laboratory. • The sampling scheme for the SYNTAX substudy is described in Figure 2. • Methods: The primary analysis compared Registry (NCDR®) defined 2 - and 3 -vessel disease vs. those from an angiographic core laboratory analysis. • Vessel-level data focusing on left main disease demonstrated that 11. 2% (17/152) of the cases called as left main disease by the core lab were deemed normal by registry data (corelab “overcall”), whereas 56. 7% (177/312) that were read as left main disease by the registry but had no left main lesion by core-lab analysis (registry “overcall”). • The primary endpoint was a vesselbased analysis evaluating the rate of concordance (i. e. the kappa coefficient) between the site and the core laboratory as to whether a significant (>50%) lesion was present by visual assessment anywhere in the vessel. • Results: Vessel-level kappa coefficients suggested moderate agreement between NCDR® and core lab analysis, ranging from kappa = 0. 39 (95% CI 0. 32 -0. 45) for the left anterior descending artery to kappa = 0. 59 (95% CI 0. 55 -0. 64) for the right coronary artery. Overall, 6. 3% (n= 127/2013) of those patients identified with multi-vessel disease at NCDR® sites had 0 - or 1 vessel disease by core lab reading. There was no direction bias with regard to “overcall. ” • Conclusions: There was only modest agreement between angiographic readings in clinical practice and those from an independent core laboratory. OBJECTIVES • Prior analyses of the appropriateness of coronary interventions have assumed that the clinical site’s assessment of disease extent and left main severity are accurate, and the angiograms have generally not been independently verified by a core laboratory. 1 -5 • The American College of Cardiology Foundation (ACCF), the Society of Thoracic Surgeons (STS), and the Duke Clinical Research Institute (DCRI) are collaborating on a comparative effectiveness study (ASCERT) of coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI). 6, 7 • An additional aim of ASCERT is to develop novel, long-term mortality risk prediction models for CABG and PCI. 8, 9 The clinical sites’ assessment of disease extent is included in these models, and the quality of the sites clinical interpretation of the angiogram is therefore integral to the validity of this model. • The goal of the present study was to assess the rate of concordance between clinical sites and an independent angiographic core laboratory in their interpretation of the angiogram, and to determine if discordance among interpreters served as a marker for poor clinical outcomes. • Clinical outcomes including death and recurrent myocardial infarction (MI) were evaluated for patients with “overcalled” left main disease (i. e. patients with left main disease by registry analysis but not by corelab analysis) compared to those with left main agreement. • Survival analysis was performed evaluating the clinical outcomes of death and recurrent MI as they relate to both negatively concordant left main disease and registry “over-call” of left main disease (Figure 3 A and 3 B). There was no statistically significant difference between groups Figure 2: Study population. Records available from SYNTAX study with angiographic analysis performed at the PERFUSE angiographic core lab. RESULTS • There was no direction bias with regard to “overcall, ” i. e. 12. 3% of cases read as 3 -vessel disease by the sites were read as < 3 -vessel disease by the core lab and 13. 9% of core lab 3 -vessel cases were read as <3 -vessel by the sites. Table 1: Analysis of agreement on vessellevel results. Kappa coefficients are presented demonstrating whethere is agreement regarding the showing presence/absence of stenosis as determined by PERFUSE vs. CATHPCI. *Disease is defined as vessel stenosis >50% • Table 1 depicts agreement between NCDR and core lab data at the vessel level. All kappa coefficients presented fall in the range of at most moderate agreement, with the highest kappa values occurring in right coronary artery group (kappa = 0. 59, 95% CI 0. 55 -0. 64). Figure 1: Left Main Disease. Is there greater than 50% LM disease? This angiogram illustrates the potential of intraand inter-observer variability Figure 3 A and 3 B: Analysis of clinical outcomes by left main agreement. Survival curves were estimated using the Kaplan-Meier method for censored data. Follow-up time was administratively censored on 31 st December 2008. For MI, patients who died were retained in the denominator, i. e, these patients were not censored on date of death. The resulting KM curves are interpreted as “actual” rather than “actuarial” probabilities. The log-rank test evaluates if there is difference between the survival curves. (A) is the Kaplan-Meier curve for the outcome of death, and (B) is the curve for recurrent myocardial infcarction. CONCLUSION There was modest agreement between angiographic readings in clinical practice and those from an independent core laboratory. Further study will be needed as the implications for patient management are uncertain. 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