Ronald J Krone1, Andrew D Althouse2, Jacqueline Tamis-Holland3, Lakshmi Venkitachalam4, Arturo Campos5, Alan Forker6, Alice K Jacobs7, Salvador Ocampo5, George Steiner8, Francisco Fuentes9, Ivan R Pena Sing10, Maria Mori Brooks2. 1. Division of Cardiology, Washington University, St. Louis, Missouri, USA. Electronic address: rkrone@dom.wustl.edu. 2. Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. 3. Mount Sinai Saint Luke's Hospital, New York, New York, USA. 4. Department of Biomedical and Health Informatics, University of Missouri-Kansas City, Kansas City, Missouri, USA. 5. Department of Cardiology, Hospital de Especialidades, Centro Medico La Raza, IMSS, Mexico City, Mexico. 6. Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, USA. 7. Boston University and Boston Medical Center, Boston, Massachusetts, USA. 8. The University of Toronto, Toronto, Ontario, Canada. 9. Division of Cardiology, The University of Texas Health Science Center at Houston, Houston, Texas, USA. 10. Heart and Vascular Catheterization Laboratories, Nanticoke Memorial Hospital, Seaford, Delaware, USA; New York University, New York, New York, USA.
Abstract
BACKGROUND: The 2012 Guidelines for Diagnosis and Management of Patients with Stable Ischemic Heart Disease recommendintensive antianginal and risk factor treatment (optimal medical management [OMT]) before considering revascularization to relieve symptoms. The Bypass Angioplasty RevascularizationInvestigation 2 Diabetes (BARI 2D) trial randomized patients with ischemic heart disease and anatomy suitable to revascularization to (1) initial OMT with revascularization if needed or (2) initialrevascularization plus OMT and found no difference in major cardiovascular events. Ultimately, however, 37.9% of the OMT group was revascularized during the 5-year follow-up period. METHODS: Data from the 1192 patients randomized toOMT were analyzed to identify subgroups in which the incidence of revascularization was so high that direct revascularization without a trial period could be justified. Multivariate logistic analysis, Cox regression models of baseline data, and a landmark analysis of participants who did not undergo revascularization at 6 months were constructed. RESULTS: The models that used only data available at the time of study entry had limited predictive value for revascularization by 6 months or by 5 years; however, the model incorporating severity of angina during the first 6 months could better predict revascularization (C statistic = 0.789). CONCLUSIONS: With the possible exception of patients with severe angina and proximal left anterior descending artery disease, this analysis supports the recommendation of the 2012 guidelines for a trial of OMT before revascularization. Patients could not be identified at the time of catheterization, but a short period of close follow-up during OMT identified the nearly 40% of patients who underwent revascularization.
RCT Entities:
BACKGROUND: The 2012 Guidelines for Diagnosis and Management of Patients with Stable Ischemic Heart Disease recommend intensive antianginal and risk factor treatment (optimal medical management [OMT]) before considering revascularization to relieve symptoms. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial randomized patients with ischemic heart disease and anatomy suitable to revascularization to (1) initial OMT with revascularization if needed or (2) initial revascularization plus OMT and found no difference in major cardiovascular events. Ultimately, however, 37.9% of the OMT group was revascularized during the 5-year follow-up period. METHODS: Data from the 1192 patients randomized to OMT were analyzed to identify subgroups in which the incidence of revascularization was so high that direct revascularization without a trial period could be justified. Multivariate logistic analysis, Cox regression models of baseline data, and a landmark analysis of participants who did not undergo revascularization at 6 months were constructed. RESULTS: The models that used only data available at the time of study entry had limited predictive value for revascularization by 6 months or by 5 years; however, the model incorporating severity of angina during the first 6 months could better predict revascularization (C statistic = 0.789). CONCLUSIONS: With the possible exception of patients with severe angina and proximal left anterior descending artery disease, this analysis supports the recommendation of the 2012 guidelines for a trial of OMT before revascularization. Patients could not be identified at the time of catheterization, but a short period of close follow-up during OMT identified the nearly 40% of patients who underwent revascularization.
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