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Comparison of Characteristics and Outcomes of Veterans With Stable Ischemic Heart Disease Enrolled in the COURAGE Trial Versus the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program

      Randomized clinical trials have not demonstrated a survival benefit with percutaneous coronary intervention in stable ischemic heart disease (SIHD). We evaluated the generalizability of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial findings to the broader population of veterans with SIHD. Veterans who underwent coronary angiography between 2005 and 2013 for SIHD were identified from the Veterans Affairs Clinical Assessment, Reporting and Tracking Program (VA CART). Patient-level comparisons were made between patients from VA CART who met the eligibility criteria for COURAGE and veterans enrolled in COURAGE between 1999 and 2004. All-cause mortality over long-term follow-up was assessed using Cox proportional hazards models. COURAGE-eligible patients from VA CART (n = 59,758) were older, had a higher body mass index, a greater prevalence of co-morbidities, but fewer diseased vessels on index coronary angiography, and were less likely to be on optimal medical therapy at baseline and on 1-year follow-up compared with VA COURAGE participants (n = 968). Patients from VA CART (median follow-up 6.5 years) had higher all-cause mortality (adjusted hazard ratio [aHR] 1.98 [1.61 to 2.43]) than participants from VA COURAGE (median follow-up: 4.6 years). Risks of mortality were greater in the 56.4% patients from CART who were medically managed (aHR 1.94 [1.49 to 2.53]) and in the 43.6% who underwent percutaneous coronary intervention (aHR 1.99 [1.45 to 2.74]), compared with their respective VA COURAGE arms. In conclusion, in this noncontemporaneous patient-level analysis, veterans in the randomized COURAGE trial had more favorable outcomes than the population of veterans with SIHD at large.
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      References

        • Fihn SD
        • Blankenship JC
        • Alexander KP
        • Bittl JA
        • Byrne JG
        • Fletcher BJ
        • Fonarow GC
        • Lange RA
        • Levine GN
        • Maddox TM
        • Naidu SS
        • Ohman EM
        • Smith PK.
        2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
        Circulation. 2014; 130: 1749-1767
        • 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
        • Stergiopoulos K
        • Boden WE
        • Hartigan P
        • Möbius-Winkler S
        • Hambrecht R
        • Hueb W
        • Hardison RM
        • Abbott JD
        • Brown DL.
        Percutaneous coronary intervention outcomes in patients with stable obstructive coronary artery disease and myocardial ischemia: a collaborative meta-analysis of contemporary randomized clinical trials.
        JAMA Intern Med. 2014; 174: 232-240
        • Rothwell PM.
        External validity of randomised controlled trials: "to whom do the results of this trial apply?.
        Lancet. 2005; 365: 82-93
        • Lauer MS.
        Commentary: how the debate about comparative effectiveness research should impact the future of clinical trials.
        Stat Med. 2012; 31: 3051-3053
        • Luce BR
        • Kramer JM
        • Goodman SN
        • Connor JT
        • Tunis S
        • Whicher D
        • Schwartz JS.
        Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change.
        Ann Intern Med. 2009; 151: 206-209
        • Sharpe N.
        Clinical trials and the real world: selection bias and generalisability of trial results.
        Cardiovasc Drugs Ther. 2002; 16: 75-77
        • Hordijk-Trion M
        • Lenzen M
        • Wijns W
        • de Jaegere P
        • Simoons ML
        • Scholte op Reimer WJ
        • Bertrand ME
        • Mercado N
        • Boersma E
        • Investigators EHS-CR
        Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the euro Heart Survey on Coronary revascularization.
        Eur Heart J. 2006; 27: 671-678
        • 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
        • Sedlis SP
        • Hartigan PM
        • Teo KK
        • Maron DJ
        • Spertus JA
        • Mancini GB
        • Kostuk W
        • Chaitman BR
        • Berman D
        • Lorin JD
        • Dada M
        • Weintraub WS
        • Boden WE
        COURAGE Trial Investigators. Effect of PCI on long-term survival in patients with stable ischemic heart disease.
        N Engl J Med. 2015; 373: 1937-1946
        • Byrd JB
        • Vigen R
        • Plomondon ME
        • Rumsfeld JS
        • Box TL
        • Fihn SD
        • Maddox TM.
        Data quality of an electronic health record tool to support VA cardiac catheterization laboratory quality improvement: the VA Clinical Assessment, Reporting, and Tracking System for Cath Labs (CART) program.
        Am Heart J. 2013; 165: 434-440
        • Maddox TM
        • Plomondon ME
        • Petrich M
        • Tsai TT
        • Gethoffer H
        • Noonan G
        • Gillespie B
        • Box T
        • Fihn SD
        • Jesse RL
        • Rumsfeld JS.
        A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program).
        Am J Cardiol. 2014; 114: 1750-1757
        • 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
        • 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
        • Boden WE
        • O'Rourke RA
        • Teo KK
        • Maron DJ
        • Hartigan PM
        • Sedlis SP
        • Dada M
        • Labedi M
        • Spertus JA
        • Kostuk WJ
        • Berman DS
        • Shaw LJ
        • Chaitman BR
        • Mancini GB
        • Weintraub WS
        COURAGE Trial Investigators. 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).
        Am J Cardiol. 2009; 104: 1-4
        • 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
        • Sohn MW
        • Arnold N
        • Maynard C
        • Hynes DM.
        Accuracy and completeness of mortality data in the Department of Veterans Affairs.
        Popul Health Metr. 2006; 4: 2
        • Spertus JA
        • Maron DJ
        • Cohen DJ
        • Kolm P
        • Hartigan P
        • Weintraub WS
        • Berman DS
        • Teo KK
        • Shaw LJ
        • Sedlis SP
        • Knudtson M
        • Aslan M
        • Dada M
        • Boden WE
        • Mancini GB
        Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) Trial Investigators and Coordinators. 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.
        Circ Cardiovasc Qual Outcomes. 2013; 6: 409-418
        • Maron DJ
        • Hochman JS
        • Reynolds HR
        • Bangalore S
        • O'Brien SM
        • Boden WE
        • Chaitman BR
        • Senior R
        • López-Sendón J
        • Alexander KP
        • Lopes RD
        • Shaw LJ
        • Berger JS
        • Newman JD
        • Sidhu MS
        • Goodman SG
        • Ruzyllo W
        • Gosselin G
        • Maggioni AP
        • White HD
        • Bhargava B
        • Min JK
        • Mancini GBJ
        • Berman DS
        • Picard MH
        • Kwong RY
        • Ali ZA
        • Mark DB
        • Spertus JA
        • Krishnan MN
        • Elghamaz A
        • Moorthy N
        • Hueb WA
        • Demkow M
        • Mavromatis K
        • Bockeria O
        • Peteiro J
        • Miller TD
        • Szwed H
        • Doerr R
        • Keltai M
        • Selvanayagam JB
        • Steg PG
        • Held C
        • Kohsaka S
        • Mavromichalis S
        • Kirby R
        • Jeffries NO
        • Harrell FE, Jr
        • Rockhold FW
        • Broderick S
        • Ferguson TB, Jr
        • Williams DO
        • Harrington RA
        • Stone GW
        • Rosenberg Y
        • ISCHEMIA Research Group
        Initial invasive or conservative strategy for stable coronary disease.
        N Engl J Med. 2020; 382: 1395-1407
        • Iqbal J
        • Zhang YJ
        • Holmes DR
        • Morice MC
        • Mack MJ
        • Kappetein AP
        • Feldman T
        • Stahle E
        • Escaned J
        • Banning AP
        • Gunn JP
        • Colombo A
        • Steyerberg EW
        • Mohr FW
        • Serruys PW.
        Optimal medical therapy improves clinical outcomes in patients undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting: insights from the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial at the 5-year follow-up.
        Circulation. 2015; 131: 1269-1277
        • Kawashima H
        • Serruys PW
        • Ono M
        • Hara H
        • O'Leary N
        • Mack MJ
        • Holmes DR
        • Morice MC
        • Head SJ
        • Kappetein AP
        • Thuijs DJFM
        • Milojevic M
        • Noack T
        • Mohr FW
        • Davierwala PM
        • Sharif F
        • McEvoy JW
        • Onuma Y
        SYNTAX Extended Survival Investigators. Impact of optimal medical therapy on 10-year mortality after coronary revascularization.
        J Am Coll Cardiol. 2021; 78: 27-38
        • Boden WE
        • Gersh BJ.
        Defining the proper SYNTAX for long-term benefit of myocardial revascularization with optimal medical therapy.
        J Am Coll Cardiol. 2021; 78: 39-41
        • Detre KM
        • Guo P
        • Holubkov R
        • Califf RM
        • Sopko G
        • Bach R
        • Brooks MM
        • Bourassa MG
        • Shemin RJ
        • Rosen AD
        • Krone RJ
        • Frye RL
        • Feit F.
        Coronary revascularization in diabetic patients: a comparison of the randomized and observational components of the Aypass angioplasty revascularization Investigation (BARI).
        Circulation. 1999; 99: 633-640
        • Maron DJ
        • Hochman JS
        • O'Brien SM
        • Reynolds HR
        • Boden WE
        • Stone GW
        • Bangalore S
        • Spertus JA
        • Mark DB
        • Alexander KP
        • Shaw L
        • Berger JS
        • Ferguson TB, Jr
        • Williams DO
        • Harrington RA
        • Rosenberg Y
        • ISCHEMIA Trial Research Group
        International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: rationale and design.
        Am Heart J. 2018; 201: 124-135
        • Fröbert O
        • Lagerqvist B
        • Olivecrona GK
        • Omerovic E
        • Gudnason T
        • Maeng M
        • Aasa M
        • Angerås O
        • Calais F
        • Danielewicz M
        • Erlinge D
        • Hellsten L
        • Jensen U
        • Johansson AC
        • Kåregren A
        • Nilsson J
        • Robertson L
        • Sandhall L
        • Sjögren I
        • Ostlund O
        • Harnek J
        • James SK
        • Trial TASTE
        Thrombus aspiration during ST-segment elevation myocardial infarction.
        N Engl J Med. 2013; 369: 1587-1597
        • Götberg M
        • Christiansen EH
        • Gudmundsdottir IJ
        • Sandhall L
        • Danielewicz M
        • Jakobsen L
        • Olsson SE
        • Öhagen P
        • Olsson H
        • Omerovic E
        • Calais F
        • Lindroos P
        • Maeng M
        • Tödt T
        • Venetsanos D
        • James SK
        • Kåregren A
        • Nilsson M
        • Carlsson J
        • Hauer D
        • Jensen J
        • Karlsson AC
        • Panayi G
        • Erlinge D
        • Fröbert O
        • iFR-SWEDEHEART Investigators
        Instantaneous wave-free ratio versus fractional flow reserve to guide PCI.
        N Engl J Med. 2017; 376: 1813-1823
        • Erlinge D
        • Omerovic E
        • Fröbert O
        • Linder R
        • Danielewicz M
        • Hamid M
        • Swahn E
        • Henareh L
        • Wagner H
        • Hårdhammar P
        • Sjögren I
        • Stewart J
        • Grimfjärd P
        • Jensen J
        • Aasa M
        • Robertsson L
        • Lindroos P
        • Haupt J
        • Wikström H
        • Ulvenstam A
        • Bhiladvala P
        • Lindvall B
        • Lundin A
        • Tödt T
        • Ioanes D
        • Råmunddal T
        • Kellerth T
        • Zagozdzon L
        • Götberg M
        • Andersson J
        • Angerås O
        • Östlund O
        • Lagerqvist B
        • Held C
        • Wallentin L
        • Scherstén F
        • Eriksson P
        • Koul S
        • James S.
        Bivalirudin versus heparin monotherapy in myocardial infarction.
        N Engl J Med. 2017; 377: 1132-1142
        • Hofmann R
        • James SK
        • Jernberg T
        • Lindahl B
        • Erlinge D
        • Witt N
        • Arefalk G
        • Frick M
        • Alfredsson J
        • Nilsson L
        • Ravn-Fischer A
        • Omerovic E
        • Kellerth T
        • Sparv D
        • Ekelund U
        • Linder R
        • Ekström M
        • Lauermann J
        • Haaga U
        • Pernow J
        • Östlund O
        • Herlitz J
        • Svensson L
        • DETO2X–SWEDEHEART Investigators
        Oxygen therapy in suspected acute myocardial infarction.
        N Engl J Med. 2017; 377: 1240-1249
        • Shaw LJ
        • Weintraub WS
        • Maron DJ
        • Hartigan PM
        • Hachamovitch R
        • Min JK
        • Dada M
        • Mancini GB
        • Hayes SW
        • O'Rourke RA
        • Spertus JA
        • Kostuk W
        • Gosselin G
        • Chaitman BR
        • Knudtson M
        • Friedman J
        • Slomka P
        • Germano G
        • Bates ER
        • Teo KK
        • Boden WE
        • Berman DS.
        Baseline stress myocardial perfusion imaging results and outcomes in patients with stable ischemic heart disease randomized to optimal medical therapy with or without percutaneous coronary intervention.
        Am Heart J. 2012; 164: 243-250
        • Mancini GB
        • Hartigan PM
        • Bates ER
        • Sedlis SP
        • Maron DJ
        • Spertus JA
        • Berman DS
        • Kostuk WJ
        • Shaw LJ
        • Weintraub WS
        • Teo KK
        • Dada M
        • Chaitman BR
        • O'Rourke RA
        • Boden WE
        COURAGE Investigators and Coordinators. Angiographic disease progression and residual risk of cardiovascular events while on optimal medical therapy: observations from the COURAGE Trial.
        Circ Cardiovasc Interv. 2011; 4: 545-552