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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.

Abstract
We 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.
AuthorsDavid 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, COURAGE Trial Research Group
JournalThe American journal of cardiology (Am J Cardiol) Vol. 104 Issue 8 Pg. 1055-62 (Oct 15 2009) ISSN: 1879-1913 [Electronic] United States
PMID19801024 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.)
Chemical References
  • Adrenergic beta-Antagonists
  • Angiotensin-Converting Enzyme Inhibitors
  • Calcium Channel Blockers
  • Nitrates
Topics
  • Adrenergic beta-Antagonists (therapeutic use)
  • Angina Pectoris (diagnosis, therapy)
  • Angiotensin-Converting Enzyme Inhibitors (therapeutic use)
  • Calcium Channel Blockers (therapeutic use)
  • Canada (epidemiology)
  • Electrocardiography
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Myocardial Infarction (epidemiology, etiology, prevention & control)
  • Myocardial Revascularization (methods)
  • Nitrates (therapeutic use)
  • Practice Guidelines as Topic
  • Prognosis
  • Quality of Life
  • Time Factors
  • United States (epidemiology)

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