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.
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.
Vanderbilt University School of Medicine, Nashville, Tennessee, USA. david.maron@vanderbilt.edu
David J
DJ
Maron
John A
JA
Spertus
G B John
GB
Mancini
Pamela M
PM
Hartigan
Steven P
SP
Sedlis
Eric R
ER
Bates
William J
WJ
Kostuk
Marcin
M
Dada
Daniel S
DS
Berman
Leslee J
LJ
Shaw
Bernard R
BR
Chaitman
Koon K
KK
Teo
Robert A
RA
O'Rourke
William S
WS
Weintraub
William E
WE
Boden
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000787:Angina Pectoris / Q000175:diagnosis / Q000628:therapy*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D002170:Canada / Q000453:epidemiology; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D009204:Myocardial Revascularization / Q000379:methods*; D009566:Nitrates / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic; D011379:Prognosis; D011788:Quality of Life; D013997:Time Factors; D014481:United States / Q000453:epidemiology
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D002121:Calcium Channel Blockers; D009566:Nitrates