Published Online
on February 11, 2008

A more recent version of this article appeared on March 11, 2008

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Submitted on October 3, 2007
Accepted on January 8, 2008

Optimal Medical Therapy With or Without Percutaneous Coronary Intervention to Reduce Ischemic Burden. Results From the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) Trial Nuclear Substudy

Leslee J. Shaw PhD^*, Daniel S. Berman MD, David J. Maron MD, G. B. John Mancini MD, Sean W. Hayes MD, Pamela M. Hartigan PhD, William S. Weintraub MD, Robert A. O’Rourke MD, Marcin Dada MD, John A. Spertus MD, MPH, Bernard R. Chaitman MD, John Friedman MD, Piotr Slomka PhD, Gary V. Heller MD, PhD, Guido Germano PhD, Gilbert Gosselin MD, Peter Berger MD, William J. Kostuk MD, Ronald G. Schwartz MD, Merill Knudtson MD, Emir Veledar PhD, Eric R. Bates MD, Benjamin McCallister MD, Koon K. Teo MD, William E. Boden MD, for the COURAGE Investigators

From Emory University School of Medicine, Atlanta, Ga (L.J.S., E.V.); Cedars-Sinai Medical Center, Los Angeles, Calif (D.S.B., S.W.H., J.F., P.S., G. Germano); Vanderbilt University Medical Center, Nashville, Tenn (D.J.M.); Vancouver Hospital and Health Sciences Centre, Vancouver, British Columbia, Canada (G.B.J.M.); Veterans Affairs Cooperative Studies Program Coordinating Center, Veterans Affairs Connecticut Healthcare System, West Haven (P.M.H.); Christiana Care Health System, Newark, Del (W.S.W.); South Texas Veterans Health Care System, San Antonio, Tex (R.A.O., G.V.H.); Hartford Hospital, Hartford, Conn (M.D.); Mid America Heart Institute/University of Missouri–Kansas City, Kansas City, Mo (J.A.S., B.M.); St Louis University, St Louis, Mo (B.R.C.); Montreal Heart Institute, Montreal, Quebec, Canada (G. Gosselin); Geisinger Clinic, Danville, Pa (P.B.); London Health Sciences Centre, London, Ontario, Canada (W.J.K.); University of Rochester, Rochester, NY (R.G.S.); Foothills Hospital, Calgary, Alberta, Canada (M.K.); University of Michigan, Ann Arbor (E.R.B.); McMaster University, Hamilton, Ontario, Canada (K.K.T.); and Western New York Veterans Affairs Healthcare Network/Buffalo General Hospital/State University of New York, Buffalo (W.E.B.).

^* To whom correspondence should be addressed. E-mail: leslee.shaw{at}emory.edu.

Background—Extent and severity of myocardial ischemia are determinants of risk for patients with coronary artery disease, and ischemia reduction is an important therapeutic goal. The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) nuclear substudy compared the effectiveness of percutaneous coronary intervention (PCI) for ischemia reduction added to optimal medical therapy (OMT) with the use of myocardial perfusion single photon emission computed tomography (MPS).

Methods and Results—Of the 2287 COURAGE patients, 314 were enrolled in this substudy of serial rest/stress MPS performed before treatment and 6 to 18 months (mean=374±50 days) after randomization using paired exercise (n=84) or vasodilator stress (n=230). A blinded core laboratory analyzed quantitative MPS measures of percent ischemic myocardium. Moderate to severe ischemia encumbered 10% myocardium. The primary end point was 5% reduction in ischemic myocardium at follow-up. Treatment groups had similar baseline characteristics. At follow-up, the reduction in ischemic myocardium was greater with PCI+OMT (-2.7%; 95% confidence interval, -1.7%, -3.8%) than with OMT (-0.5%; 95% confidence interval, -1.6%, 0.6%; P<0.0001). More PCI+OMT patients exhibited significant ischemia reduction (33% versus 19%; P=0.0004), especially patients with moderate to severe pretreatment ischemia (78% versus 52%; P=0.007). Patients with ischemia reduction had lower unadjusted risk for death or myocardial infarction (P=0.037 [risk-adjusted P=0.26]), particularly if baseline ischemia was moderate to severe (P=0.001 [risk-adjusted P=0.08]). Death or myocardial infarction rates ranged from 0% to 39% for patients with no residual ischemia to 10% residual ischemia on follow-up MPS (P=0.002 [risk-adjusted P=0.09]).

Conclusions—In COURAGE patients who underwent serial MPS, adding PCI to OMT resulted in greater reduction in ischemia compared with OMT alone. Our findings suggest a treatment target of 5% ischemia reduction with OMT with or without coronary revascularization.

Key words: ischemia • perfusion • prevention • prognosis

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