This application proposes evaluation of new device usage pattern, as well as immediate and follow up outcomes in patients undergoing percutaneous transluminal coronary revascularization. This proposed study complements prior NHLBI PTCA Registries in 1977 - 1981, 1985 - 1986, and the """"""""New Approaches to Coronary Intervention (NACI) Registry"""""""" in 1990 - 1994. Endpoints: Procedure characteristics, in hospital outcomes and one year follow-up (death/MI, CABG, repeat PTCA and other non-invasive revascularization) will be compared to the two previous registries in 1977-1981, and 1985-1986, and also between the different waves of the 2000 patients studied 18 months apart. Twelve of the 13 principal investigators for this study have participated in the NHLBI PTCA Registry for more than 15 years. Extensive training sessions will be conducted in Pittsburgh during the first month of the project to assure understanding of the patient sampling scheme, angiographic definitions, follow-up, data collection, instruments, and all other facets of this study. Core Laboratories will not be used. Based on previous experience, incidence of myocardial infarction etc., can be evaluated by routine straightforward questions. Similarly, an Angiographic Core Laboratory is not considered essential since procedural strategies are based on the local interventionalist's assessment rather than the Core Laboratory's evaluation, which is particularly the aim of the practice-based strategy of this Registry. However, it is planned to have an Angiographic Core Laboratory over read a random sample of films from each center. Reports from this study will provide the cardiology community with the facts needed for selection of appropriate interventional therapies, and for the design of clinical trials to evaluate competing devices in selected settings. This is an important opportunity to evaluate success rate and complications. It would be valuable to have a designated individual to set up definitions of complications and review the most serious events. The registry data of such defined complications provides an opportunity to evaluate safety and complications of different types of PTCA procedure, patient population and interactions, (e.g. with drugs). This type of information can be only possible if there is a uniform definition of complications. However, there are no concerns are comments regarding the study WOMEN AND MINORITIES In the previous review of this application, the investigators had proposed to collect registry data on approximately 25% women and 10% minorities and this was deemed inadequate to answer critical ethnic and gender differences on utilization. The previous review recommended additional or replacement centers to increase the representation of minorities and women. In response, the investigators have modified the sampling scheme to over sample consecutive women and minority patients at the end of each wave. Two new sites, with a relatively higher representation of minorities, have been added. The strategies outlined in the revised application should yield a 30% final sample of women and a 20% minority rate via over sampling once a """"""""cap"""""""" of white males is reached. Overall, it is felt that the investigators have been highly responsive to this concern. BUDGET In the previous review, the recommendation was that the doctoral-level support be reduced to 30%. In accordance, it is recommended that the current doctoral level of 40% be reduced as follows: Dr. Holubukove percent effort be reduced from 20 to 15%, and that Drs. Kelsey and Detre be maintained at 15 and 5%, respectively.
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