1018-46 Influence of Randomized Trials on Clinical Practice: A Comparison of Directional Atherectomy and New Device Use Before and After the CAVEAT Trial at CAVEAT Sites

Abstract

In order to evaluate the impact of the Coronary Angioplasty versus Excisional Atherectomy Trial (CAVEAT-I) on practice patterns of coronary intervention, a week-long registry of the “universe” of all coronary interventions performed at 35 investigational sites between April 18 and 22, 1994 was compared with a similar registry obtained before the trial was initiated. A total of 97% of sites responded. Additional sites which took part in CAVEAT-II comparing DCA and PTCA in vein grafts were also audited for generalizability:DeviceCAVEAT-I sitesCAVEAT-II sitespre-CAVEATpost-CAVEATpost-CAVEATn%n%n%PTCA53983.844.368.530778.1DCA6910.79114.1399.9Other355411317.54712* P < 0.0001*p value for comparison of CAVEAT-I sites pre vs. post CAVEAT p value for comparison of CAVEAT-I sites pre vs. post CAVEAT There has been a significant decline in the proportion of procedures relying exclusively on balloon angioplasty and paradoxically, despite the negative findings of CAVEAT-I, a noteworthy trend towards an increase in use of DCA and other devices at CAVEAT sites. This paradoxic increase in trend was still evident when subgroup analysis of American and European CAVEAT-I sites was performed. These findings suggest that even among investigators in the trial, there is a lack of influence of CAVEAT-I data on clinical practice patterns.