Frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial

Circulation: Cardiovascular Quality and Outcomes

Volumn 6, Issue 4, 2013, Pages 409-418

  Spertus, John A ^a   Maron, David J ^b   Cohen, David J ^a   Kolm, Paul ^c   Hartigan, Pam ^d   Weintraub, William S ^c   Berman, Daniel S ^e   Teo, Koon K ^f   Shaw, Leslee J ^g   Sedlis, Steven P ^h   Knudtson, Merril ⁱ   Aslan, Mihaela ^d   Dada, Marcin ^j   Boden, William E ^k   John Mancini, G B ^l  

^a UNIVERSITY OF MISSOURI KANSAS CITY   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^c CHRISTIANA CARE HEALTH SYSTEM   (United States)

^d VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^e CEDARS SINAI MEDICAL CENTER   (United States)

^f MCMASTER UNIVERSITY MEDICAL CENTRE   (Canada)

^g EMORY UNIVERSITY   (United States)

^h NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ LIBIN CARDIOVASCULAR INSTITUTE OF ALBERTA   (Canada)

^j HARTFORD HOSPITAL   (United States)

^k UNIVERSITY AT BUFFALO   (United States)

^l UNIVERSITY OF BRITISH COLUMBIA   (Canada)

more..

Author keywords

Angina; Chronic coronary artery disease; Clinical trials; Percutaneous coronary interventions; Quality of life

Indexed keywords

ADULT; ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE ASSOCIATION; FEMALE; HEALTH CARE SYSTEM; HEALTH STATUS; HEART MUSCLE REVASCULARIZATION; HUMAN; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SEATTLE ANGINA QUESTIONNAIRE; TREATMENT OUTCOME;

ANGINA; CHRONIC CORONARY ARTERY DISEASE; CLINICAL TRIALS; PERCUTANEOUS CORONARY INTERVENTIONS; QUALITY OF LIFE;

AGED; ANGINA, UNSTABLE; CARDIOVASCULAR AGENTS; CHI-SQUARE DISTRIBUTION; COMORBIDITY; CORONARY STENOSIS; CROSS-OVER STUDIES; FEMALE; HEALTH STATUS; HUMANS; LOGISTIC MODELS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; NORTH AMERICA; PATIENT ADMISSION; PATIENT SATISFACTION; PERCUTANEOUS CORONARY INTERVENTION; PROPORTIONAL HAZARDS MODELS; QUALITY OF LIFE; QUESTIONNAIRES; RISK FACTORS; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84884498150     PISSN: 19417713     EISSN: 19417705     Source Type: Journal    
DOI: 10.1161/CIRCOUTCOMES.113.000139     Document Type: Article

References (31)

1. Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB III, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV, Anderson JL. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012;126:e354-e471.
2. Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356:1503-1516.
3. Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk W, Knudtson M, Dada M, Casperson P, Harris CL, Spertus JA, Shaw L, Chaitman BR, Mancini GB, Berman DS, Weintraub WS; COURAGE Trial Coprincipal Investigators and Study Coordinators. 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.
4. Diamond GA, Kaul S. From here to eternity: a unified kinetic model for the pathophysiology of atherosclerotic events. Am J Med. 2007;120:5-11.
5. Fraker TD Jr, Fihn SD, Gibbons RJ, Abrams J, Chatterjee K, Daley J, Deedwania PC, Douglas JS, Ferguson TB Jr, Gardin JM, O'Rourke RA, Williams SV, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 chronic angina focused update of the ACC/AHA 2002 guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association task force on practice guidelines writing group to develop the focused update of the 2002 guidelines for the management of patients with chronic stable angina. J Am Coll Cardiol. 2007;50:2264-2274.
6. Gibbons RJ, Abrams J, Chatterjee K, Daley J, Deedwania PC, Douglas JS, Ferguson TB Jr, Fihn SD, Fraker TD Jr, Gardin JM, O'Rourke RA, Pasternak RC, Williams SV, Alpert JS, Antman EM, Hiratzka LF, Fuster V, Faxon DP, Gregoratos G, Jacobs AK, Smith SC Jr. 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). Circulation. 2003;107:149-158.
7. Califf RM, Phillips HR III, Hindman MC, Mark DB, Lee KL, Behar VS, Johnson RA, Pryor DB, Rosati RA, Wagner GS. Prognostic value of a coronary artery jeopardy score. J Am Coll Cardiol. 1985;5:1055-1063.
8. Mancini GB, Bates ER, Maron DJ, Hartigan P, Dada M, Gosselin G, Kostuk W, Sedlis SP, Shaw LJ, Berman DS, Berger PB, Spertus J, Mavromatis K, Knudtson M, Chaitman BR, O'Rourke RA, Weintraub WS, Teo K, Boden WE; COURAGE Trial Investigators and Coordinators. Quantitative results of baseline angiography and percutaneous coronary intervention in the COURAGE trial. Circ Cardiovasc Qual Outcomes. 2009;2:320-327.
9. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol. 1994;74:1240-1244.
10. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. 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.
11. Spertus JA, Jones P, McDonell M, Fan V, Fihn SD. Health status predicts long-term outcome in outpatients with coronary disease. Circulation. 2002;106:43-49.
12. Mozaffarian D, Bryson CL, Spertus JA, McDonell MB, Fihn SD. Anginal symptoms consistently predict total mortality among outpatients with coronary artery disease. Am Heart J. 2003;146:1015-1022.
13. Arnold SV, Morrow DA, Lei Y, Cohen DJ, Mahoney EM, Braunwald E, Chan PS. Economic impact of angina after an acute coronary syndrome: insights from the MERLIN-TIMI 36 trial. Circ Cardiovasc Qual Outcomes. 2009;2:344-353.
14. Austin PC. The performance of different propensity score methods for estimating marginal odds ratios. Stat Med. 2007;26:3078-3094.
15. Austin PC. A critical appraisal of propensity-score matching in the medical literature between 1996 and 2003. Stat Med. 2008;27:2037-2049.
16. Spertus J. Selecting end points in clinical trials: what evidence do we really need to evaluate a new treatment? Am Heart J. 2001;142:745-747.
17. Mark DB, Naylor CD, Hlatky MA, Califf RM, Topol EJ, Granger CB, Knight JD, Nelson CL, Lee KL, Clapp-Channing NE. Use of medical resources and quality of life after acute myocardial infarction in Canada and the United States. N Engl J Med. 1994;331:1130-1135.
18. Rouleau JL, Moyé LA, Pfeffer MA, Arnold JM, Bernstein V, Cuddy TE, Dagenais GR, Geltman EM, Goldman S, Gordon D. A comparison of management patterns after acute myocardial infarction in Canada and the United States. The SAVE investigators. N Engl J Med. 1993;328:779-784.
19. Pilote L, Racine N, Hlatky MA. Differences in the treatment of myocardial infarction in the United States and Canada. A comparison of two university hospitals. Arch Intern Med. 1994;154:1090-1096.
20. Tu JV, Pashos CL, Naylor CD, Chen E, Normand SL, Newhouse JP, McNeil BJ. Use of cardiac procedures and outcomes in elderly patients with myocardial infarction in the United States and Canada. N Engl J Med. 1997;336:1500-1505.
21. Petersen LA, Normand SL, Leape LL, McNeil BJ. Regionalization and the underuse of angiography in the Veterans Affairs Health Care System as compared with a fee-for-service system. N Engl J Med. 2003;348:2209-2217.
22. Anderson GM, Grumbach K, Luft HS, Roos LL, Mustard C, Brook R. Use of coronary artery bypass surgery in the United States and Canada. Influence of age and income. JAMA. 1993;269:1661-1666.
23. Wennberg DE, Birkmeyer NJO, Lucas FL, Malenka DJ, McGrath PD, O'Connor GT, Quinton HB, Shawver TA, Stewers AE. The Dartmouth atlas of cardiovascular health care. 1999:288.
24. Lucas FL, Siewers AE, Malenka DJ, Wennberg DE. Diagnostictherapeutic cascade revisited: coronary angiography, coronary artery bypass graft surgery, and percutaneous coronary intervention in the modern era. Circulation. 2008;118:2797-2802.
25. Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization: a report of the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology: endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography. Circulation. 2009;119:1330-1352.
26. Smith SC Jr, Dove JT, Jacobs AK, Kennedy JW, Kereiakes D, Kern MJ, Kuntz RE, Popma JJ, Schaff HV, Williams DO, Gibbons RJ, Alpert JP, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines)-executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions. Circulation. 2001;103:3019-3041.
27. Eagle KA, Guyton RA, Davidoff R, Edwards FH, Ewy GA, Gardner TJ, Hart JC, Herrmann HC, Hillis LD, Hutter AM Jr, Lytle BW, Marlow RA, Nugent WC, Orszulak TA, Antman EM, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Ornato JP. ACC/AHA 2004 guideline update for coronary artery bypass graft surgery: summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee to update the 1999 guidelines for coronary artery bypass graft surgery). Circulation. 2004;110:1168-1176.
28. Maron DJ, Boden WE, O'Rourke RA, Hartigan PM, Calfas KJ, Mancini GB, Spertus JA, Dada M, Kostuk WJ, Knudtson M, Harris CL, Sedlis SP, Zoble RG, Title LM, Gosselin G, Nawaz S, Gau GT, Blaustein AS, Bates ER, Shaw LJ, Berman DS, Chaitman BR, Weintraub WS, Teo KK; COURAGE Trial Research Group. Intensive multifactorial intervention for stable coronary artery disease: optimal medical therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial. J Am Coll Cardiol. 2010;55:1348-1358.
29. Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE, Mancini GB; COURAGE Trial Research Group. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008;359:677-687.
30. O'Gara PT. The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial: can we deliver on its promise? J Am Coll Cardiol. 2010;55:1359-1361.
31. Weintraub WS, Boden WE, Zhang Z, Kolm P, Zhang Z, Spertus JA, Hartigan P, Veledar E, Jurkovitz C, Bowen J, Maron DJ, O'Rourke R, Dada M, Teo KK, Goeree R, Barnett PG; Department of Veterans Affairs Cooperative Studies Program No. 424 (COURAGE Trial) Investigators and Study Coordinators. Cost-effectiveness of percutaneous coronary intervention in optimally treated stable coronary patients. Circ Cardiovasc Qual Outcomes. 2008;1:12-20.