RELIABILITY OF THE QUANTITATIVE ANGIOGRAPHIC MEASUREMENTS IN THE NEW-APPROACHES-TO-CORONARY-INTERVENTION (NACI) REGISTRY - A COMPARISON OF CLINICAL SITE AND REPEATED ANGIOGRAPHIC CORE LABORATORY READINGS

To assess the agreement of clinical site and angiographic core laborat ory readings obtained in the New Approaches to Coronary intervention ( NACI) registry, we reviewed the angiographic results obtained in 787 l esions assessed both by the sites and the core laboratory, including 1 35 lesions analyzed twice (greater than or equal to 2 months apart) by the angiographic core laboratory, Although moderate agreement was dem onstrated between the clinical site and angiographic core laboratory f or qualitative lesion morphology such as lesion calcium (kappa [kappa] = 0.42), only fair agreement was found between site and core laborato ry estimation of lesion ulceration (kappa = 0.33); thrombus (kappa = 0 .30); and eccentricity (kappa = 0.27); with poor agreement for angulat ion (kappa = 0.16); and proximal vessel tortuosity (kappa = 0.03). Agr eement for qualitative morphology was better for repeated core laborat ory readings of lesion eccentricity (kappa = 0.75); angulation (kappa = 0.72); thrombus (kappa = 0.68); proximal vessel tortuosity (kappa = 0.66); and calcification (kappa = 0.64), Quantitative angiographic mea surements correlated moderately between the clinical site using the di gital caliper method and the core laboratory using the automated edge- detection method, including preprocedural percentage diameter stenosis (intraclass correlation [R] = 0.50) and postprocedural percentage dia meter stenosis (R = 0.63). Repeated core laboratory readings had almos t perfect agreement, with R ranging from 0.88 for postprocedural perce ntage diameter stenosis to 0.93 for reference vessel diameter and pre- and postprocedural minimal lumen diameters. Repeated angiographic cor e laboratory readings provided highly consistent quantitative and qual itative morphologic results in the NACI registry, but the core laborat ory readings varied substantially from those obtained at the clinical site, More standardized angiographic analytic criteria and core labora tory feedback to investigators may improve agreement between the clini cal sites and the angiographic core laboratory in subsequent studies. (C) 1997 by Excerpta Medica, Inc.