• Am. J. Cardiol. · Oct 2009

    Randomized Controlled Trial Multicenter Study Comparative Study

    Impact of an initial strategy of medical therapy without percutaneous coronary intervention in high-risk patients from the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial.

    • David J Maron, John A Spertus, G B John Mancini, Pamela M Hartigan, Steven P Sedlis, Eric R Bates, William J Kostuk, Marcin Dada, Daniel S Berman, Leslee J Shaw, Bernard R Chaitman, Koon K Teo, Robert A O'Rourke, William S Weintraub, William E Boden, and COURAGE Trial Research Group.
    • Vanderbilt University School of Medicine, Nashville, Tennessee, USA. david.maron@vanderbilt.edu
    • Am. J. Cardiol. 2009 Oct 15;104(8):1055-62.

    AbstractWe explored the safety and quality-of-life consequences of treating patients with stable coronary disease and high-risk features initially with optimal medical therapy (OMT) alone compared to OMT plus percutaneous coronary intervention. This was a post hoc analysis of Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial patients. We defined high risk as the onset of Canadian Cardiovascular Society class III angina within 2 months or stabilized acute coronary syndrome within 2 weeks of enrollment. The primary end point was death or myocardial infarction after 4.6 years. Of the 2,287 patients enrolled in the COURAGE trial, 264 (12%) were high risk and had a relative risk of 1.56 for death or myocardial infarction (p = 0.0008) compared to those with non-high-risk features. A total of 35 primary events occurred in the OMT group and 32 in the percutaneous coronary intervention plus OMT group (hazard ratio 1.11, 95% confidence interval 0.69 to 1.79; p = 0.68). No significant difference was found in the prevalence of angina between the 2 groups at 1 year. During the first year of follow-up, 30% of the OMT patients crossed over to the revascularization group. In conclusion, an initial strategy of OMT alone for high-risk patients in the COURAGE trial did not result in increased death or myocardial infarction at 4.6 years or worse angina at 1 year, but it was associated with a high rate of crossover to revascularization.

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