Journal of Nuclear Cardiology

, Volume 20, Issue 6, pp 969–975

Lessons learned from MPI and physiologic testing in randomized trials of stable ischemic heart disease: COURAGE, BARI 2D, FAME, and ISCHEMIA

  • Lawrence M. Phillips
  • Rory Hachamovitch
  • Daniel S. Berman
  • Ami E. Iskandrian
  • James K. Min
  • Michael H. Picard
  • Raymond Y. Kwong
  • Matthias G. Friedrich
  • Marielle Scherrer-Crosbie
  • Sean W. Hayes
  • Tali Sharir
  • Gilbert Gosselin
  • Marco Mazzanti
  • Roxy Senior
  • Rob Beanlands
  • Paola Smanio
  • Abhi Goyal
  • Mouaz Al-Mallah
  • Harmony Reynolds
  • Gregg W. Stone
  • David J. Maron
  • Leslee J. Shaw
Perspective

Abstract

There is a preponderance of evidence that, in the setting of an acute coronary syndrome, an invasive approach using coronary revascularization has a morbidity and mortality benefit. However, recent stable ischemic heart disease (SIHD) randomized clinical trials testing whether the addition of coronary revascularization to guideline-directed medical therapy (GDMT) reduces death or major cardiovascular events have been negative. Based on the evidence from these trials, the primary role of GDMT as a front line medical management approach has been clearly defined in the recent SIHD clinical practice guideline; the role of prompt revascularization is less precisely defined. Based on data from observational studies, it has been hypothesized that there is a level of ischemia above which a revascularization strategy might result in benefit regarding cardiovascular events. However, eligibility for recent negative trials in SIHD has mandated at most minimal standards for ischemia. An ongoing randomized trial evaluating the effectiveness of randomization of patients to coronary angiography and revascularization as compared to no coronary angiography and GDMT in patients with moderate-severe ischemia will formally test this hypothesis. The current review will highlight the available evidence including a review of the published and ongoing SIHD trials.

Keywords

Myocardial perfusion imaging ischemia coronary artery disease clinical trials 

References

  1. 1.
    Mehta SR, Cannon CP, Fox KA, Wallentin L, Boden WE, Spacek R, et al. Routine vs selective invasive strategies in patients with acute coronary syndromes: A collaborative meta-analysis of randomized trials. J Am Med Assoc 2005;293:2908-17.CrossRefGoogle Scholar
  2. 2.
    Lagerqvist B, Husted S, Kontny F, Stahle E, Swahn E, Wallentin L. 5-Year outcomes in the FRISC-II randomized trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: A follow-up study. Lancet 2006;368:998-1004.PubMedCrossRefGoogle Scholar
  3. 3.
    Lakkis N, Tsyboulev V, Gibson CM, Murphy SA, Weintraub WS, DiBattiste PM, et al. Outcome of patients with acute coronary syndrome admitted to hospitals with or without onsite cardiac catheterization laboratory: A TACTICS-TIMI 18 substudy. Crit Pathw Cardiol 2002;1:232-7.PubMedCrossRefGoogle Scholar
  4. 4.
    Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007;356:1503-16.PubMedCrossRefGoogle Scholar
  5. 5.
    Frye RL, August P, Brooks MM, Hardison RM, Kelsey SF, MacGregor JM, et al. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med 2009;360:2503-15.PubMedCrossRefGoogle Scholar
  6. 6.
    Beller GA, Zaret BL. Contributions of nuclear cardiology to diagnosis and prognosis of patients with coronary artery disease. Circulation 2000;101:1465-78.PubMedCrossRefGoogle Scholar
  7. 7.
    Shaw LJ, Iskandrian AE. Prognostic value of gated myocardial perfusion SPECT. J Nucl Cardiol 2004;11:171-85.PubMedCrossRefGoogle Scholar
  8. 8.
    Shaw L, Achenbach S, Narula J. Anatomy trumps all! JACC Cardiovasc Imaging 2013;6:745-6. doi:10.1016/j.jcmg.2013.05.001.PubMedCrossRefGoogle Scholar
  9. 9.
    Hachamovitch R, Berman DS, Shaw LJ, Kiat H, Cohen I, Cabico JA, et al. Incremental prognostic value of myocardial perfusion single photon emission computed tomography for the prediction of cardiac death: Differential stratification for risk of cardiac death and myocardial infarction. Circulation 1998;97:535-43.PubMedCrossRefGoogle Scholar
  10. 10.
    Califf RM, Armstrong PW, Carver JR, D’Agostino RB, Strauss WE. 27th Bethesda conference: Matching the intensity of risk factor management with the hazard for coronary disease events. Task Force 5. Stratification of patients into high, medium and low risk subgroups for purposes of risk factor management. J Am Coll Cardiol 1996;27:1007-19.PubMedCrossRefGoogle Scholar
  11. 11.
    Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, et al. 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. J Am Coll Cardiol 2012;60:e44-164. doi:10.1016/j.jacc.2012.07.013.PubMedCrossRefGoogle Scholar
  12. 12.
    Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography. Circulation 2003;107:2900-7.PubMedCrossRefGoogle Scholar
  13. 13.
    Moroi M, Yamashina A, Tsukamoto K, Nishimura T, J-ACCESS Investigators. Coronary revascularization does not decrease cardiac events in patients with stable ischemic heart disease but might do in those who showed moderate to severe ischemia. Int J Cardiol 2012;158:246-52.PubMedCrossRefGoogle Scholar
  14. 14.
    Califf RM, Armstrong PW, Carver JR, D’Agostino RB, Strauss WE. 27th Bethesda conference: Matching the intensity of risk factor management with the hazard for coronary disease events. Task Force 5. Stratification of patients into high, medium and low risk subgroups for purposes of risk factor management. J Am Coll Cardiol 1995;27:1007-19.CrossRefGoogle Scholar
  15. 15.
    Kwon DH, Hachamovitch R, Popovic ZB, Starling RC, Desai MY, Flamm SD, et al. Survival in patients with severe ischemic cardiomyopathy undergoing revascularization versus medical therapy: Association with end-systolic volume and viability. Circulation 2012;126:S3-8.PubMedCrossRefGoogle Scholar
  16. 16.
    Ling LF, Marwick TH, Flores DR, Jaber WA, Brunken RC, Cerqueira MD, et al. Identification of therapeutic benefit from revascularization in patients with left ventricular systolic dysfunction: Inducible ischemia versus hibernating myocardium. Circ Cardiovasc Imaging 2013;6:363-72.PubMedCrossRefGoogle Scholar
  17. 17.
    Panza JA, Holly TA, Asch FM, She L, Pellikka PA, Velazquez EJ, et al. Inducible myocardial ischemia and outcomes in patients with coronary artery disease and left ventricular dysfunction. J Am Coll Cardiol 2013;61:1860-70.PubMedCrossRefGoogle Scholar
  18. 18.
    Shaw LJ, Weintraub WS, Maron DJ, Hartigan PM, Hachamovitch R, Min JK, et al. 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;164:243-50.PubMedCrossRefGoogle Scholar
  19. 19.
    Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, et al. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med 2008;359:677-87.PubMedCrossRefGoogle Scholar
  20. 20.
    Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, et al. 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;117:1283-91.PubMedCrossRefGoogle Scholar
  21. 21.
    Shaw LJ, Heller GV, Casperson P, Miranda-Peats R, Friedman J, Hayes SW, et al. Gated myocardial perfusion single photon emission computed tomography imaging in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trial. J Nucl Cardiol 2006;13:685-98.PubMedCrossRefGoogle Scholar
  22. 22.
    Slomka PJ, Nishina H, Berman DS, Akincioglu C, Abidov A, Friedman JD, et al. Automated quantification of myocardial perfusion SPECT using simplified normal limits. J Nucl Cardiol 2005;12:66-77.PubMedCrossRefGoogle Scholar
  23. 23.
    Iskandrian AE, Heo J, Mehta D, Tauxe EL, Yester M, Hall MB, et al. Gated SPECT perfusion imaging for the simultaneous assessment of myocardial perfusion and ventricular function in the BARI 2D trial: An initial report from the nuclear core laboratory. J Nucl Cardiol 2006;13:83-90.PubMedCrossRefGoogle Scholar
  24. 24.
    Shaw LJ, Cerqueira MD, Brooks MM, Althose AD, Sansing VV, Beller GA, et al. Impact of left ventricular function and the extent of ischemia and scar by stress myocardial perfusion imaging on prognosis and therapeutic risk reduction in diabetic patients with coronary artery disease: Results from the bypass angioplasty revascularization investigation 2 diabetes (BARI 2D) trial. J Nucl Cardiol 2012;19:658-69.PubMedCrossRefGoogle Scholar
  25. 25.
    Mahmarian JJ, Shaw LJ, Olszewski GH, Pounds BK, Frias ME, Pratt CM, et al. Adenosine sestamibi SPECT post-infarction evaluation (INSPIRE) trial: A randomized, prospective multicenter trial evaluating the role of adenosine Tc-99m sestamibi SPECT for assessing risk and therapeutic outcomes in survivors of acute myocardial infarction. J Nucl Cardiol 2004;11:458-69.PubMedCrossRefGoogle Scholar
  26. 26.
    Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van’ t Veer M, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213-24.PubMedCrossRefGoogle Scholar
  27. 27.
    Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol 2010;56:177-84.PubMedCrossRefGoogle Scholar
  28. 28.
    De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med 2012;367:991-1001.PubMedCrossRefGoogle Scholar
  29. 29.
    Christou MA, Siontis GC, Katritsis DG, Ioannidis JP. Meta-analysis of fractional flow reserve versus quantitative coronary angiography and noninvasive imaging for evaluation of myocardial ischemia. Am J Cardiol 2007;99:450-6.PubMedCrossRefGoogle Scholar
  30. 30.
    Melikian N, De Bondt P, Tonino P, De Winter O, Wyffels E, Bartunek J, et al. Fractional flow reserve and myocardial perfusion imaging in patients with angiographic multivessel coronary artery disease. JACC Cardiovasc Interv 2010;3:307-14.PubMedCrossRefGoogle Scholar
  31. 31.
    www.ischemiatrial.org. Accessed 31 July 2013.

Copyright information

© American Society of Nuclear Cardiology 2013

Authors and Affiliations

  • Lawrence M. Phillips
    • 1
  • Rory Hachamovitch
    • 2
  • Daniel S. Berman
    • 3
  • Ami E. Iskandrian
    • 4
  • James K. Min
    • 5
  • Michael H. Picard
    • 6
  • Raymond Y. Kwong
    • 7
  • Matthias G. Friedrich
    • 8
  • Marielle Scherrer-Crosbie
    • 6
  • Sean W. Hayes
    • 3
  • Tali Sharir
    • 9
  • Gilbert Gosselin
    • 8
  • Marco Mazzanti
    • 10
  • Roxy Senior
    • 11
  • Rob Beanlands
    • 12
  • Paola Smanio
    • 13
  • Abhi Goyal
    • 14
  • Mouaz Al-Mallah
    • 15
  • Harmony Reynolds
    • 1
  • Gregg W. Stone
    • 16
  • David J. Maron
    • 17
  • Leslee J. Shaw
    • 14
  1. 1.New York University School of MedicineNew YorkUSA
  2. 2.Cleveland Clinic FoundationClevelandUSA
  3. 3.Cedars-Sinai Medical CenterLos AngelesUSA
  4. 4.University of Alabama – BirminghamBirminghamUSA
  5. 5.Weill Cornell Medical CollegeNew YorkUSA
  6. 6.Massachusetts General HospitalBostonUSA
  7. 7.Brigham and Women’s HospitalBostonUSA
  8. 8.Montreal Heart InstituteMontrealCanada
  9. 9.Assuta Medical CenterTel AvivIsrael
  10. 10.University Hospital of AnconaAnconaItaly
  11. 11.Northwick Park HospitalLondonUnited Kingdom
  12. 12.Ottawa Heart InstituteOttawaCanada
  13. 13.Instituto Dante Pazzanese de CardiologiaSão PauloBrazil
  14. 14.Emory University School of MedicineAtlantaUSA
  15. 15.King Abdulaziz Cardiac CenterRiyadhSaudi Arabia
  16. 16.New York Presbyterian Hospital/Columbia University Medical CenterNew YorkUSA
  17. 17.Vanderbilt UniversityNashvilleUSA

Personalised recommendations