Design and rationale of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial Veterans Affairs Cooperative Studies Program no. 424.
BACKGROUND
Major improvements in medical therapy and percutaneous coronary intervention (PCI) for coronary heart disease have occurred during the past decade, but no randomized trial has compared these 2 strategies for the "hard" clinical end points of death or myocardial infarction nor have earlier studies incorporated the use of coronary stents and aggressive multifaceted medical therapy during long-term follow-up.


METHODS
The COURAGE trial is a multicenter study of patients with documented myocardial ischemia and angiographically confirmed single or multivessel coronary artery disease who are randomized to a strategy of PCI plus intensive medical therapy or intensive medical therapy alone. Medical therapy in both groups is guideline-driven and includes: aspirin, clopidogrel, simvastatin (low-density lipoprotein cholesterol target 60-85 mg/dL), long-acting metoprolol and/or amlodipine, lisinopril or losartan, and long-acting nitrates, as well as lifestyle interventions. The primary end point is a composite of all-cause mortality or acute myocardial infarction, and there will be 85% power to detect an absolute 4.6% (relative 22%) difference between strategies. The principal hypothesis is that PCI plus aggressive medical therapy (projected event rate 16.4%) will be superior to aggressive medical therapy alone (projected event rate 21%) during a 2.5- to 7-year (median of 5 years) follow-up.


CONCLUSIONS
COURAGE is the largest prospective randomized trial of PCI versus intensive medical therapy to date and will define the incremental benefits of PCI in the setting of contemporary optimal medical therapy for chronic coronary heart disease. A total of 2287 patients have been enrolled, and follow-up will conclude in June 2006.
Boden
William E
WE
VA Connecticut Healthcare System, West Haven, CT, USA. wboden@harthosp.org
O'rourke
Robert A
RA
Teo
Koon K
KK
Hartigan
Pamela M
PM
Maron
David J
DJ
Kostuk
William
W
Knudtson
Merril
M
Dada
Marcin
M
Casperson
Paul
P
Harris
Crystal L
CL
Spertus
John A
JA
Shaw
Leslee
L
Chaitman
Bernard R
BR
Mancini
G B John
GB
Berman
Daniel S
DS
Weintraub
William S
WS
D003324:Coronary Artery Disease / Q000628:therapy*; D006801:Humans; D015337:Multicenter Studies as Topic; D017202:Myocardial Ischemia / Q000628:therapy*; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design