Journal of the American College of Cardiology Vol. 55, No.

13, 2010
© 2010 by the American College of Cardiology Foundation ISSN 0735-1097/10/$36.00
Published by Elsevier Inc. doi:10.1016/j.jacc.2009.11.061

QUARTERLY FOCUS ISSUE: PREVENTION/OUTCOMES

Editorial Comment

The COURAGE (Clinical Outcomes Utilizing

The primary goals of treatment for patients with stable neous coronary intervention with optimal medical therapy
(chronic) coronary artery disease (CAD) include the pre- (PCI ⫹ OMT) and those assigned to OMT had been
vention of death and myocardial infarction (MI) and the consistently observed in other, smaller trials of this nature
relief of ischemic symptoms. In this regard, medical therapy (9). There were also no significant differences between
and revascularization comprise complementary approaches. groups for the secondary composite end point of death, MI,
Despite the dissemination of evidence-based practice guide- and stroke; for hospital stay for acute coronary syndrome;
lines (1–3) and appropriate use criteria (4), there is wide- and for MI. However, nearly one-third of patients in the
spread recognition that clinical decision-making varies con- OMT group required revascularization for clinical indica-
siderably among physicians, practice groups, and health tions over the course of follow-up, and patients who
systems, particularly with respect to the threshold at which underwent PCI initially reported better angina-specific
percutaneous coronary intervention (PCI) is undertaken. As health status and quality of life over the first 6 to 24 months
an example, in an observational cohort study of 2004 of the study, differences that were no longer apparent at 3
Medicare beneficiaries, less than one-half (44.5%) under- years (10). A small substudy of the COURAGE trial
went stress testing in the 90 days before elective PCI (5). suggested that PCI might provide relatively greater reduc-
There is equal concern that the intensity and scope of tion in ischemic burden (11), an observation that merits
medical therapy are often not accorded the attention they further study.
deserve. The reasons for these discrepancies are some- The observed event rates in the COURAGE trial were
times embedded in the context of an individual patient’s substantially lower than predicted, due in part to the excellent
clinical course and its dynamic change. Certainly, no one background therapy provided to the study participants. Inter-
size fits all. Several lines of evidence, however, suggest estingly, the major outcomes in the COURAGE trial were
that opportunities remain to narrow the gap between similar to those reported in the EuroHeart Survey for a
recommended and applied management strategies for
subgroup of patients with stable angina and angiographi-
patients with chronic CAD.
cally confirmed CAD (rate of death or nonfatal MI 3.9 per
100 patient-years) (12). Overestimation of clinical event
See page 1348
rates in medically managed patients has been observed in
recent post-MI and acute coronary syndrome trials (13,14).
In the more than 2 years since publication of its main
The implication is clear that the aggressive medical and
results, the COURAGE (Clinical Outcomes Utilizing Re-
lifestyle interventions employed in such trials are effective
vascularization and Aggressive Drug Evaluation) trial has
and safe for large numbers of patients across the CAD
been the subject of intense scrutiny and editorial comment
spectrum. Whether they can be implemented in routine
(6 – 8). That there was no difference in the primary com-
posite outcome (death from any cause and nonfatal MI) clinical practice, outside the confines of a well-executed
between patients assigned to an initial strategy of percuta- clinical trial, remains to be seen.
In this issue of the Journal, the COURAGE investigators
describe in greater detail the components of the multimo-
dality treatment program used for both the PCI and OMT
*Editorials published in the Journal of the American College of Cardiology reflect the
views of the authors and do not necessarily represent the views of JACC or the
groups, adherence rates observed over the course of the trial,
American College of Cardiology. and the targets achieved (15). It is self-evident that the
From the Cardiovascular Division, Department of Medicine, Brigham and remarkable results seen across multiple domains were in no
Women’s Hospital, Harvard Medical School, Boston, Massachusetts. Dr. O’Gara
is the chair of the Data Monitoring Committee of Lantheus Medical Imaging, small measure related to regularly scheduled nurse manager
and is a consultant for E-Valve. visits and the provision of most medications (including
1360 O’Gara JACC Vol. 55, No. 13, 2010
The COURAGE Trial: Can We Deliver on Its Promise? March 30, 2010:1359–61

statins, clopidogrel, beta-blockers, and either angiotensin- tural competence, and reimbursement. The current battles
converting enzyme inhibitors or angiotensin receptor block- surrounding health care reform do not engender much
ers) at no cost to the patient. The degree to which patient optimism, despite the emphasis on prevention in some of
demographics (85% male, 86% white, 42% U.S. veterans) the proposed legislation. It would be easy to dismiss the
might have influenced the results is unclear. The adherence COURAGE trial results as being too impractical, expen-
rates observed for the use of evidence-based medications for sive, or difficult to replicate in practice, were it not for the
secondary prevention and ischemia management establish a fact that this is precisely the direction in which multiple
new benchmark for patients with chronic CAD. Significant programs for quality and performance improvement have
improvements were noted for smoking cessation, dietary pointed. It is also relevant to underscore the recognition that
composition, and physical activity levels, yet body mass approximately one-half of the recent decline in U.S. deaths
index increased slightly, the hemoglobin A1c levels of from coronary heart disease might be attributable to reduc-
patients with diabetes at baseline did not change, and 8% of tions in major risk factors (26). Implementation will require
patients developed diabetes over the course of the study. policymakers to make difficult but informed choices about
The blood pressure and lipid levels achieved were exem- what can be done to improve the public health in ways that
plary, although 30% to 40% of patients did not meet the are both predictable and affordable from patient-centered
pre-specified targets of ⬍130 mm Hg systolic blood pres- and societal perspectives.
sure and ⬍85 mg/dl for low-density lipoprotein cholesterol,
respectively, despite the disciplined manner in which pa- Reprint requests and correspondence: Dr. Patrick T. O’Gara,
tients were managed. Lastly, there were no differences Cardiovascular Division, Department of Medicine, Brigham and
between the PCI and OMT groups in the intensity with Women’s Hospital, Harvard Medical School, 75 Francis Street,
which the interventions were applied, the (surrogate) end Boston, Massachusetts 02115. E-mail: pogara@partners.org.
points achieved, or treatment satisfaction scores.
The COURAGE trial reinforces several important con-
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