TY - JOUR
T1 - Impact of Optimal Medical Therapy With or Without Percutaneous Coronary Intervention on Long-Term Cardiovascular End Points in Patients With Stable Coronary Artery Disease (from the COURAGE Trial)
AU - Boden, William E.
AU - O'Rourke, Robert A.
AU - Teo, Koon K.
AU - Maron, David J.
AU - Hartigan, Pamela M.
AU - Sedlis, Steven P.
AU - Dada, Marcin
AU - Labedi, Mohammed
AU - Spertus, John A.
AU - Kostuk, William J.
AU - Berman, Daniel S.
AU - Shaw, Leslee J.
AU - Chaitman, Bernard R.
AU - Mancini, G. B.John
AU - Weintraub, William S.
N1 - Funding Information:
This study was sponsored by the Department of Veterans Affairs Cooperative Studies Program. Additional funding was provided by the Canadian Institutes of Health Research. Supplemental corporate support from several pharmaceutical companies included funding and in-kind support. All support from the pharmaceutical industry consisted of unrestricted research grants payable to the Department of Veterans Affairs.
Funding Information:
The rationale, design, baseline characteristics, and main results of the COURAGE trial have been described previously. 1–3 Sponsorship and oversight of the trial were provided by the Department of Veterans Affairs Cooperative Studies Program. Additional funding was provided by the Canadian Institutes of Health Research. Supplemental corporate support from several pharmaceutical companies included funding and in-kind support. All support from the pharmaceutical industry consisted of unrestricted research grants payable to the Department of Veterans Affairs. Clinical outcomes were adjudicated by an independent committee whose members were unaware of treatment assignments.
PY - 2009/7/1
Y1 - 2009/7/1
N2 - The main results of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial revealed no significant differences in the primary end point of all-cause mortality or nonfatal myocardial infarction [MI] or major secondary end points (composites of death/MI/stroke; hospitalization for acute coronary syndromes [ACSs]) during a median 4.6-year follow-up in 2,287 patients with stable coronary artery disease randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). We sought to assess the impact of PCI when added to OMT on major prespecified tertiary cardiovascular outcomes (time to first event), namely cardiac death and composites of cardiac death/MI, cardiac death/MI/hospitalization for ACS, cardiac death/MI/stroke, MI/stroke, or cardiac death/MI/ACS/stroke, during study follow-up. There were no significant differences between treatment arms for the composite of cardiac death or MI (15% in PCI + OMT group vs 14.2% in OMT group, hazard ratio 1.07, 95% confidence interval 0.86 to 1.33, p = 0.62) or in any of the major prespecified composite cardiovascular events during long-term follow-up, even after excluding periprocedural MI as an outcome of interest. Overall, cause-specific cardiovascular outcomes paralleled closely the primary and secondary composite outcomes of the trial as a whole. In conclusion, compared with an initial management strategy of OMT alone, addition of PCI did not decrease the incidence of major cardiovascular outcomes including cardiac death or the composite of cardiac death/MI/ACS/stroke in patients with stable coronary artery disease.
AB - The main results of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial revealed no significant differences in the primary end point of all-cause mortality or nonfatal myocardial infarction [MI] or major secondary end points (composites of death/MI/stroke; hospitalization for acute coronary syndromes [ACSs]) during a median 4.6-year follow-up in 2,287 patients with stable coronary artery disease randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). We sought to assess the impact of PCI when added to OMT on major prespecified tertiary cardiovascular outcomes (time to first event), namely cardiac death and composites of cardiac death/MI, cardiac death/MI/hospitalization for ACS, cardiac death/MI/stroke, MI/stroke, or cardiac death/MI/ACS/stroke, during study follow-up. There were no significant differences between treatment arms for the composite of cardiac death or MI (15% in PCI + OMT group vs 14.2% in OMT group, hazard ratio 1.07, 95% confidence interval 0.86 to 1.33, p = 0.62) or in any of the major prespecified composite cardiovascular events during long-term follow-up, even after excluding periprocedural MI as an outcome of interest. Overall, cause-specific cardiovascular outcomes paralleled closely the primary and secondary composite outcomes of the trial as a whole. In conclusion, compared with an initial management strategy of OMT alone, addition of PCI did not decrease the incidence of major cardiovascular outcomes including cardiac death or the composite of cardiac death/MI/ACS/stroke in patients with stable coronary artery disease.
UR - http://www.scopus.com/inward/record.url?scp=67649385760&partnerID=8YFLogxK
U2 - 10.1016/j.amjcard.2009.02.059
DO - 10.1016/j.amjcard.2009.02.059
M3 - Article
C2 - 19576311
AN - SCOPUS:67649385760
SN - 0002-9149
VL - 104
SP - 1
EP - 4
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 1
ER -