Incorporation of bleeding as an element of the composite end point in clinical trials of antithrombotic therapies in patients with non-ST-segment elevation acute coronary syndrome: Validity, pitfalls, and future approaches

American Heart Journal

Volumn 165, Issue 5, 2013, Pages

  Subherwal, Sumeet ^a   Ohman, E Magnus ^a   Mahaffey, Kenneth W ^a   Rao, Sunil V ^a   Alexander, John H ^a   Wang, Tracy Y ^a   Alexander, Karen P ^a   Hasselblad, Vic ^a   Roe, Matthew T ^a  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FONDAPARINUX; HIRULOG;

ANTICOAGULANT THERAPY; BLEEDING; EXPERIMENTAL THERAPY; HEART INFARCTION; HEART MUSCLE ISCHEMIA; INCIDENCE; MORTALITY; NON ST SEGMENT ELEVATION ACUTE CORONARY SYNDROME; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; STENT THROMBOSIS; THERAPY EFFECT; TREATMENT RESPONSE; VALIDITY;

EID: 84876783218     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2012.11.012     Document Type: Review

References (55)

1. S.D. Wiviott, E. Braunwald, and C.H. McCabe Prasugrel versus clopidogrel in patients with acute coronary syndromes N Engl J Med 357 2007 2001 2015
2. G.W. Stone, B.T. McLaurin, and D.A. Cox Bivalirudin for patients with acute coronary syndromes N Engl J Med 355 2006 2203 2216
3. The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators S. Yusuf, and S.R. Mehta Comparison of fondaparinux and enoxaparin in acute coronary syndromes N Engl J Med 354 2006 1464 1476
4. J.J. Ferguson, R.M. Califf, and E.M. Antman Enoxaparin versusunfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial JAMA 292 2004 45 54
5. L. Wallentin, R.C. Becker, and A. Budaj Ticagrelor versus clopidogrel in patients with acute coronary syndromes N Engl J Med 361 2009 1045 1057
6. G.W. Stone, H.D. White, and E.M. Ohman Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial Lancet 369 2007 907 919
7. M.T. Roe, J.C. Messenger, and W.S. Weintraub Treatments, trends, and outcomes of acute myocardial infarction and percutaneous coronary intervention J Am Coll Cardiol 56 2010 254 263
8. F.A. Spencer, M. Moscucci, and C.B. Granger Does comorbidity account for the excess mortality in patients with major bleeding in acute myocardial infarction? Circulation 116 2007 2793 2801
9. S.V. Rao, J.G. Jollis, and R.A. Harrington Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes JAMA 292 2004 1555 1562
10. S.V. Rao, K. O'Grady, and K.S. Pieper Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes Am J Cardiol 96 2005 1200 1206
11. J.W. Eikelboom, S.R. Mehta, and S.S. Anand Adverse impact of bleeding on prognosis in patients with acute coronary syndromes Circulation 114 2006 774 782
12. R. Mehran, S.J. Pocock, and E. Nikolsky A risk score to predict bleeding in patients with acute coronary syndromes J Am Coll Cardiol 55 2010 2556 2566
13. C.W. Hamm, J.P. Bassand, and S. Agewall ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation Eur Heart J 32 2011 2999 3054
14. J.H. Alexander, R.D. Lopes, and S. James Apixaban with antiplatelet therapy after acute coronary syndrome N Engl J Med 365 2011 699 708
15. P. Tricoci, Z. Huang, and C. Held Thrombin-receptor antagonist vorapaxar in acute coronary syndromes N Engl J Med 366 2012 20 33
16. A.M. Lincoff, J.A. Bittl, and R.A. Harrington Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial JAMA 289 2003 853 863
17. R.S. Wright, J.L. Anderson, and C.D. Adams 2011 ACCF/AHA focused update of the guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons J Am Coll Cardiol 57 2011 1920 1959
18. S. Yusuf, F. Zhao, and S.R. Mehta Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation N Engl J Med 345 2001 494 502
19. S.R. Mehta, J.F. Tanguay, and J.W. Eikelboom Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial Lancet 376 2010 1233 1243
20. D.L. Bhatt, M.T. Roe, and E.D. Peterson Utilization of early invasive management strategies for high-risk patients with non-ST-segment elevation acute coronary syndromes: results from the CRUSADE Quality Improvement Initiative JAMA 292 2004 2096 2104
21. V.M. Montori, G. Permanyer-Miralda, and I. Ferreira-González Validity of composite end points in clinical trials BMJ 330 2005 594 596
22. G. Tomlinson, and A.S. Detsky Composite end points in randomized trials: there is no free lunch JAMA 303 2010 267 268
23. I. Ferreira-González, J.W. Busse, and D. Heels-Ansdell Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials BMJ 334 2007 786
24. E. Lim, A. Brown, and A. Helmy Composite outcomes in cardiovascular research: a survey of randomized trials Ann Intern Med 149 2008 612 617
25. F. Feit, M.D. Voeltz, and M.J. Attubato Predictors and impact of major hemorrhage on mortality following percutaneous coronary intervention from the REPLACE-2 Trial Am J Cardiol 100 2007 1364 1369
26. A. Budaj, J.W. Eikelboom, and S.R. Mehta Improving clinical outcomes by reducing bleeding in patients with non-ST-elevation acute coronary syndromes Eur Heart J 30 2009 655 661
27. S.V. Manoukian, F. Feit, and R. Mehran Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial J Am Coll Cardiol 49 2007 1362 1368
28. R. Mehran, S.J. Pocock, and G.W. Stone Associations of major bleeding and myocardial infarction with the incidence and timing of mortality in patients presenting with non-ST-elevation acute coronary syndromes: a risk model from the ACUITY trial Eur Heart J 30 2009 1457 1466
29. A. Segev, B.H. Strauss, and M. Tan Predictors and 1-year outcome of major bleeding in patients with non-ST-elevation acute coronary syndromes: insights from the Canadian Acute Coronary Syndrome Registries Am Heart J 150 2005 690 694
30. M. Moscucci, K.A. Fox, and C.P. Cannon Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE) Eur Heart J 24 2003 1815 1823
31. R.D. Lopes, S. Subherwal, and D.N. Holmes The association of in-hospital major bleeding with short-, intermediate-, and long-term mortality among older patients with non-ST-segment elevation myocardial infarction Eur Heart J 33 2012 2044 2053
32. S.V. Rao, J.A. Eikelboom, and C.B. Granger Bleeding and blood transfusion issues in patients with non-ST-segment elevation acute coronary syndromes Eur Heart J 28 2007 1193 1204
33. W. Hochholzer, S.D. Wiviott, and E.M. Antman Predictors of bleeding and time dependence of association of bleeding with mortality: insights from the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38 (TRITON-TIMI 38 Circulation 123 2011 2681 2689
34. C.G. Koch, L. Li, and D.I. Sessler Duration of red-cell storage and complications after cardiac surgery N Engl J Med 358 2008 1229 1239
35. E. Fransen, J. Maessen, and M. Dentener Impact of blood transfusions on inflammatory mediator release in patients undergoing cardiac surgery Chest 116 1999 1233 1239
36. T.Y. Wang, L. Xiao, and K.P. Alexander Antiplatelet therapy use after discharge among acute myocardial infarction patients with in-hospital bleeding Circulation 118 2008 2139 2145
37. K. Thygesen, J.S. Alpert, and H.D. White Universal definition of myocardial infarction Circulation 116 2007 2634 2653
38. D.E. Cutlip, S. Windecker, and R. Mehran Clinical end points in coronary stent trials: a case for standardized definitions Circulation 115 2007 2344 2351
39. The GUSTO Investigators An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction N Engl J Med 329 1993 673 682
40. J. Chesebro, G. Knatterud, and R. Roberts Thrombolysis in Myocardial Infarction (TIMI) Trial. Phase I: a comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge Circulation 76 1987 142 154
41. S.V. Rao, K. O'Grady, and K.S. Pieper A comparison of the clinical impact of bleeding measured by 2 different classifications among patients with acute coronary syndromes J Am Coll Cardiol 47 2006 809 816
42. R.P. Giugliano, J.A. White, and C. Bode Early versus delayed, provisional eptifibatide in acute coronary syndromes N Engl J Med 360 2009 2176 2190
43. S. Subherwal, R.G. Bach, and A.Y. Chen Baseline risk of major bleeding in non-ST-segment-elevation myocardial infarction: the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines) Bleeding Score Circulation 119 2009 1873 1882
44. R. Mathews, E.D. Peterson, and A.Y. Chen In-hospital major bleeding during ST-elevation and non-ST-elevation myocardial infarction care: derivation and validation of a model from the ACTION Registry®-GWTG™ Am J Cardiol 107 2011 1136 1143
45. R. Mehran, S.V. Rao, and D.L. Bhatt Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium Circulation 123 2011 2736 2747
46. M. Valgimigli, G. Campo, and M. Monti Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial Circulation 125 2012 2015 2026
47. G. Ndrepepa, T. Schuster, and M. Hadamitzky Validation of the bleeding academic research consortium definition of bleeding in patients with coronary artery disease undergoing percutaneous coronary intervention Circulation 125 2012 1424 1431
48. M.L. Simoons GUSTO IV-ACS Investigators. Effect of glycoprotein IIb/IIIa receptor blocker abciximab on outcome in patients with acute coronary syndromes without early coronary revascularisation: the GUSTO IV-ACS randomised trial Lancet 357 2001 1915 1924
49. A. Kastrati, J. Mehilli, and F.J. Neumann Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment: the ISAR-REACT 2 randomized trial JAMA 295 2006 1531 1538
50. P.G. Steg, K. Huber, and F. Andreotti Bleeding in acute coronary syndromes and percutaneous coronary interventions: position paper by the Working Group on Thrombosis of the European Society of Cardiology Eur Heart J 32 2011 1854 1864
51. P.C. O'Brien Procedures for comparing samples with multiple end points Biometrics 40 1984 1079 1087
52. R. Califf, and L. Harrelson-Woodlief Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials Circulation 82 1990 1847 1853
53. J.M. Lachin Worst-rank score analysis with informatively missing observations in clinical trials Control Clin Trials 20 1999 408 422
54. S.J. Pocock, C.A. Ariti, and T.J. Collier The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities Eur Heart J 33 2012 176 182
55. P.W. Armstrong, C.M. Westerhout, and F. Van de Werf Refining clinical trial composite outcomes: an application to the Assessment of the Safety and Efficacy of a New Thrombolytic-3 (ASSENT-3) trial Am Heart J 161 2011 848 854