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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

Published:September 01, 2009DOI:https://doi.org/10.1016/j.amjcard.2009.05.056
      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.
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      References

        • Boden W.E.
        • O'Rourke R.A.
        • Teo K.K.
        • Hartigan P.M.
        • Maron D.J.
        • Kostuk W.J.
        • Knudtson M.
        • Dada M.
        • Casperson P.
        • Harris C.L.
        • Chaitman B.R.
        • Shaw L.
        • Gosselin G.
        • Nawaz S.
        • Title L.M.
        • Gau G.
        • Blaustein A.S.
        • Booth D.C.
        • Bates E.R.
        • Spertus J.A.
        • Berman D.S.
        • Mancini G.B.
        • Weintraub W.S.
        Optimal medical therapy with or without PCI for stable coronary disease.
        N Engl J Med. 2007; 356: 1503-1516
        • Weintraub W.S.
        • Spertus J.A.
        • Kolm P.
        • Maron D.J.
        • Zhang Z.
        • Jurkovitz C.
        • Zhang W.
        • Hartigan P.M.
        • Lewis C.
        • Veledar E.
        • Bowen J.
        • Dunbar S.B.
        • Deaton C.
        • Kaufman S.
        • O'Rourke R.A.
        • Goeree R.
        • Barnett P.G.
        • Teo K.K.
        • Boden W.E.
        • Mancini G.B.
        Effect of PCI on quality of life in patients with stable coronary disease.
        N Engl J Med. 2008; 359: 677-687
        • Boden W.E.
        • O'Rourke R.A.
        • Teo K.K.
        • Hartigan P.M.
        • Maron D.J.
        • Kostuk W.
        • Knudtson M.
        • Dada M.
        • Casperson P.
        • Harris C.L.
        • Spertus J.A.
        • Shaw L.
        • Chaitman B.R.
        • Mancini G.B.
        • Berman D.S.
        • Weintraub W.S.
        Design and rationale of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial Veterans Affairs Cooperative Studies Program no. 424.
        Am Heart J. 2006; 151: 1173-1179
        • Gibbons R.J.
        • Abrams J.
        • Chatterjee K.
        • Daley J.
        • Deedwania P.C.
        • Douglas J.S.
        • Ferguson Jr, T.B.
        • Fihn S.D.
        • Fraker Jr, T.D.
        • Gardin J.M.
        • O'Rourke R.A.
        • Pasternak R.C.
        • Williams S.V.
        ACC/AHA 2002 guideline update for the management of patients with chronic stable angina—summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Chronic Stable Angina).
        J Am Coll Cardiol. 2003; 41: 159-168
        • Braunwald E.
        • Antman E.M.
        • Beasley J.W.
        • Califf R.M.
        • Cheitlin M.D.
        • Hochman J.S.
        • Jones R.H.
        • Kereiakes D.
        • Kupersmith J.
        • Levin T.N.
        • Pepine C.J.
        • Schaeffer J.W.
        • Smith III, E.E.
        • Steward D.E.
        • Theroux P.
        • Gibbons R.J.
        • Alpert J.S.
        • Faxon D.P.
        • Fuster V.
        • Gregoratos G.
        • Hiratzka L.F.
        • Jacobs A.K.
        • Smith Jr, S.C.
        ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction—summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina).
        J Am Coll Cardiol. 2002; 40: 1366-1374
        • Spertus J.A.
        • Winder J.A.
        • Dewhurst T.A.
        • Deyo R.A.
        • Prodzinski J.
        • McDonell M.
        • Fihn S.D.
        Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease.
        J Am Coll Cardiol. 1995; 25: 333-341
        • Spertus J.A.
        • Winder J.A.
        • Dewhurst T.A.
        • Deyo R.A.
        • Fihn S.D.
        Monitoring the quality of life in patients with coronary artery disease.
        Am J Cardiol. 1994; 74: 1240-1244
        • Spertus J.A.
        • Jones P.
        • McDonell M.
        • Fan V.
        • Fihn S.D.
        Health status predicts long-term outcome in outpatients with coronary disease.
        Circulation. 2002; 106: 43-49
        • Zhang Z.
        • Mahoney E.M.
        • Stables R.H.
        • Booth J.
        • Nugara F.
        • Spertus J.A.
        • Weintraub W.S.
        Disease-specific health status after stent-assisted percutaneous coronary intervention and coronary artery bypass surgery: one-year results from the Stent or Surgery trial.
        Circulation. 2003; 108: 1694-1700
        • Theroux P.
        • Fuster V.
        Acute coronary syndromes: unstable angina and non–Q-wave myocardial infarction.
        Circulation. 1998; 97: 1195-1206
        • Weaver W.D.
        • Simes R.J.
        • Betriu A.
        • Grines C.L.
        • Zijlstra F.
        • Garcia E.
        • Grinfeld L.
        • Gibbons R.J.
        • Ribeiro E.E.
        • DeWood M.A.
        • Ribichini F.
        Comparison of primary coronary angioplasty and intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review.
        JAMA. 1997; 278: 2093-2098
        • Keeley E.C.
        • Boura J.A.
        • Grines C.L.
        Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials.
        Lancet. 2003; 361: 13-20
        • Ottervanger J.P.
        • Armstrong P.
        • Barnathan E.S.
        • Boersma E.
        • Cooper J.S.
        • Ohman E.M.
        • James S.
        • Wallentin L.
        • Simoons M.L.
        Association of revascularisation with low mortality in non-ST elevation acute coronary syndrome: a report from GUSTO IV-ACS.
        Eur Heart J. 2004; 25: 1494-1501
        • Mehta S.R.
        • Cannon C.P.
        • Fox K.A.
        • Wallentin L.
        • Boden W.E.
        • Spacek R.
        • Widimsky P.
        • McCullough P.A.
        • Hunt D.
        • Braunwald E.
        • Yusuf S.
        Routine vs selective invasive strategies in patients with acute coronary syndromes: a collaborative meta-analysis of randomized trials.
        JAMA. 2005; 293: 2908-2917
        • Shaw L.J.
        • Berman D.S.
        • Maron D.J.
        • Mancini G.B.
        • Hayes S.W.
        • Hartigan P.M.
        • Weintraub W.S.
        • O'Rourke R.A.
        • Dada M.
        • Spertus J.A.
        • Chaitman B.R.
        • Friedman J.
        • Slomka P.
        • Heller G.V.
        • Germano G.
        • Gosselin G.
        • Berger P.
        • Kostuk W.J.
        • Schwartz R.G.
        • Knudtson M.
        • Veledar E.
        • Bates E.R.
        • McCallister B.
        • Teo K.K.
        • Boden W.E.
        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.
        Circulation. 2008; 117: 1283-1291
        • Malenka D.J.
        • Kaplan A.V.
        • Lucas F.L.
        • Sharp S.M.
        • Skinner J.S.
        Outcomes following coronary stenting in the era of bare-metal vs the era of drug-eluting stents.
        JAMA. 2008; 299: 2868-2876
        • Tu J.V.
        • Bowen J.
        • Chiu M.
        • Ko D.T.
        • Austin P.C.
        • He Y.
        • Hopkins R.
        • Tarride J.E.
        • Blackhouse G.
        • Lazzam C.
        • Cohen E.A.
        • Goeree R.
        Effectiveness and safety of drug-eluting stents in Ontario.
        N Engl J Med. 2007; 357: 1393-1402
        • Mauri L.
        • Silbaugh T.S.
        • Wolf R.E.
        • Zelevinsky K.
        • Lovett A.
        • Zhou Z.
        • Resnic F.S.
        • Normand S.L.
        Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts.
        Circulation. 2008; 118: 1817-1827
        • Kastrati A.
        • Mehilli J.
        • Pache J.
        • Kaiser C.
        • Valgimigli M.
        • Kelbaek H.
        • Menichelli M.
        • Sabate M.
        • Suttorp M.J.
        • Baumgart D.
        • Seyfarth M.
        • Pfisterer M.E.
        • Schomig A.
        Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents.
        N Engl J Med. 2007; 356: 1030-1039
        • Spaulding C.
        • Daemen J.
        • Boersma E.
        • Cutlip D.E.
        • Serruys P.W.
        A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents.
        N Engl J Med. 2007; 356: 989-997
        • Stettler C.
        • Wandel S.
        • Allemann S.
        • Kastrati A.
        • Morice M.C.
        • Schomig A.
        • Pfisterer M.E.
        • Stone G.W.
        • Leon M.B.
        • de Lezo J.S.
        • Goy J.J.
        • Park S.J.
        • Sabate M.
        • Suttorp M.J.
        • Kelbaek H.
        • Spaulding C.
        • Menichelli M.
        • Vermeersch P.
        • Dirksen M.T.
        • Cervinka P.
        • Petronio A.S.
        • Nordmann A.J.
        • Diem P.
        • Meier B.
        • Zwahlen M.
        • Reichenbach S.
        • Trelle S.
        • Windecker S.
        • Juni P.
        Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis.
        Lancet. 2007; 370: 937-948
        • James S.K.
        • Stenestrand U.
        • Lindback J.
        • Carlsson J.
        • Schersten F.
        • Nilsson T.
        • Wallentin L.
        • Lagerqvist B.
        Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden.
        N Engl J Med. 2009; 360: 1933-1945