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
Received 11 April 2008; received in revised form 20 May 2008; accepted 20 May 2008. published online 01 September 2009.
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.
aVanderbilt University School of Medicine, Nashville, Tennessee
bMid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri
cUniversity of British Columbia, Vancouver, British Columbia, Canada
dVeterans Affairs Cooperative Studies Program Coordinating Center, West Haven, Connecticut
eNew York Veterans Affairs Medical Center, New York, New York
fUniversity of Michigan Medical Center, Ann Arbor, Michigan
gLondon Health Sciences Centre, London, Ontario, Canada
oWestern New York Veterans Affairs Healthcare Network and Department of Medicine, Buffalo General Hospital-State University of New York, Buffalo, New York
This work was supported by the Cooperative Studies Program of the United States Department of Veterans Affairs Office of Research and Development [Veterans Affairs Cooperative Studies Program no. 424]; in collaboration with the Canadian Institutes of Health Research; and by unrestricted research grants from Merck (Whitehouse Station, New Jersey), Pfizer (New York, New York), Bristol-Myers-Squibb (New York, New York), Fujisawa (Tokyo, Japan), Kos Pharmaceuticals (Abbott Park, Illinois), Datascope (Fairfield, New Jersey), AstraZeneca (London, United Kingdom), Key Pharmaceutical (Sydney, Australia), Sanofi-Aventis (Paris, France), First Horizon (Alpharetta, Georgia), and GE Healthcare (Waukesha, Wisconsin). All industrial funding in support of the trial was directed through the United States Department of Veterans Affairs.