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J Am Coll Cardiol, 2007; 49:1362-1368, doi:10.1016/j.jacc.2007.02.027 (Published online 8 March 2007).
© 2007 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

Impact of Major Bleeding on 30-Day Mortality and Clinical Outcomes in Patients With Acute Coronary Syndromes

An Analysis From the ACUITY Trial

Steven V. Manoukian, MD, FACC*,*, Frederick Feit, MD, FACC{dagger}, Roxana Mehran, MD, FACC{ddagger}, Michele D. Voeltz, MD*, Ramin Ebrahimi, MD, FACC§, Martial Hamon, MD||, George D. Dangas, MD, PhD, FACC{ddagger}, A. Michael Lincoff, MD, FACC, Harvey D. White, DSc, FACC#, Jeffrey W. Moses, MD, FACC{ddagger}, Spencer B. King, III, MD, MACC**, E. Magnus Ohman, MD, FACC{dagger}{dagger} and Gregg W. Stone, MD, FACC{ddagger}

* Department of Medicine, Emory University School of Medicine, Atlanta, Georgia
** Fuqua Heart Center, Atlanta, Georgia
{dagger} Department of Medicine, New York University School of Medicine, New York, New York
{ddagger} Department of Medicine, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
§ Department of Medicine, University of California Los Angeles, Los Angeles, California
|| Service des Maladies du Coeur et des Vaisseaux, Centre Hospitalier Universitaire de Caen, Caen, France
Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio
# Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
{dagger}{dagger} Department of Medicine, Duke University School of Medicine, Durham, North Carolina.

Manuscript received February 10, 2007; revised manuscript received February 26, 2007, accepted February 26, 2007.

* Reprint requests and correspondence: Dr. Steven V. Manoukian, Emory University School of Medicine, Emory Crawford Long Hospital, 550 Peachtree Street, MOT, 6th Floor, Cardiology, Atlanta, Georgia 30308. (Email: steven.manoukian{at}emory.edu).

Objectives: The purpose of this study was to determine the predictors of major bleeding and the impact of major bleeding on outcomes, including mortality, in acute coronary syndromes (ACS).

Background: Whether major bleeding independently predicts mortality in patients with ACS undergoing an early invasive strategy is undefined.

Methods: Patients (n = 13,819) with moderate- and high-risk ACS were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy (plus provisional GPI). Logistic regression was used to determine predictors of 30-day major bleeding and mortality.

Results: Major bleeding rates in patients treated with heparin plus GPI were higher versus bivalirudin monotherapy (5.7% vs. 3.0%, p < 0.001) and similar versus bivalirudin plus GPI (5.7% vs. 5.3%, p = 0.38). Independent predictors of major bleeding were advanced age, female gender, diabetes, hypertension, renal insufficiency, anemia, no prior percutaneous coronary intervention, cardiac biomarker elevation, ST-segment deviation ≥1 mm, and treatment with heparin plus GPI versus bivalirudin monotherapy. Patients with major bleeding had higher 30-day rates of mortality (7.3% vs. 1.2%, p < 0.0001), composite ischemia (23.1% vs. 6.8%, p < 0.0001), and stent thrombosis (3.4% vs. 0.6%, p < 0.0001) versus those without major bleeding. Major bleeding was an independent predictor of 30-day mortality (odds ratio 7.55, 95% confidence interval 4.68 to 12.18, p < 0.0001).

Conclusions: Major bleeding is a powerful independent predictor of 30-day mortality in patients with ACS managed invasively. Several factors independently predict major bleeding, including treatment with heparin plus GPI compared with bivalirudin monotherapy. Knowledge of these findings might be useful to reduce bleeding risk and improve outcomes in ACS.

Abbreviations and Acronyms
  ACS = acute coronary syndromes
  CABG = coronary artery bypass graft surgery
  GRACE = Global Registry of Acute Coronary Events
  GPI = glycoprotein IIb/IIIa inhibitor/inhibition
  MI = myocardial infarction
  PCI = percutaneous coronary intervention




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S. S. Jolly, D. P. Faxon, K. A.A. Fox, R. Afzal, W. E. Boden, P. Widimsky, P. G. Steg, V. Valentin, A. Budaj, C. B. Granger, et al.
Efficacy and Safety of Fondaparinux Versus Enoxaparin in Patients With Acute Coronary Syndromes Treated With Glycoprotein IIb/IIIa Inhibitors or Thienopyridines: Results From the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) Trial
J. Am. Coll. Cardiol., July 28, 2009; 54(5): 468 - 476.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
R. Mehran, S. J. Pocock, G. W. Stone, T. C. Clayton, G. D. Dangas, F. Feit, S. V. Manoukian, E. Nikolsky, A. J. Lansky, A. Kirtane, et al.
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., June 2, 2009; 30(12): 1457 - 1466.
[Abstract] [Full Text] [PDF]

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 Circ Cardiovasc IntervHome page
S. K. Mehta, A. D. Frutkin, J. B. Lindsey, J. A. House, J. A. Spertus, S. V. Rao, F.-S. Ou, M. T. Roe, E. D. Peterson, S. P. Marso, et al.
Bleeding in Patients Undergoing Percutaneous Coronary Intervention: The Development of a Clinical Risk Algorithm From the National Cardiovascular Data Registry
Circ Cardiovasc Interv, June 1, 2009; 2(3): 222 - 229.
[Abstract] [Full Text] [PDF]

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 Eur Heart J SupplHome page
R. Mehran and G. W. Stone
New paradigms of care for STEMI focusing on mortality and attributable death analysis: what do device and drug trials teach us?
Eur. Heart J. Suppl., June 1, 2009; 11(suppl_C): C4 - C8.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
T. Y. Wang, F.-S. Ou, M. T. Roe, R. A. Harrington, E. M. Ohman, W. B. Gibler, and E. D. Peterson
Incidence and Prognostic Significance of Thrombocytopenia Developed During Acute Coronary Syndrome in Contemporary Clinical Practice
Circulation, May 12, 2009; 119(18): 2454 - 2462.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
S. Subherwal, R. G. Bach, A. Y. Chen, B. F. Gage, S. V. Rao, L. K. Newby, T. Y. Wang, W. B. Gibler, E. M. Ohman, M. T. Roe, et al.
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, April 14, 2009; 119(14): 1873 - 1882.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
S. S. Jolly, J. Pogue, K. Haladyn, R. J.G. Peters, K. A.A. Fox, A. Avezum, B. J. Gersh, H. J. Rupprecht, S. Yusuf, and S. R. Mehta
Effects of aspirin dose on ischaemic events and bleeding after percutaneous coronary intervention: insights from the PCI-CURE study
Eur. Heart J., April 2, 2009; 30(8): 900 - 907.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
S. Koul and D. J. Moliterno
Bare-Metal Versus Drug-Eluting Stent Placement Among Patients Presenting With Anemia
J. Am. Coll. Cardiol. Intv., April 1, 2009; 2(4): 337 - 338.
[Full Text] [PDF]

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 ChestHome page
S. Manzano-Fernandez, F. Marin, F. J. Pastor-Perez, C. Caro, F. Cambronero, J. Lacunza, E. Pinar, D. A. Pascual-Figal, M. Valdes, and G. Y. H. Lip
Impact of Chronic Kidney Disease on Major Bleeding Complications and Mortality in Patients With Indication for Oral Anticoagulation Undergoing Coronary Stenting
Chest, April 1, 2009; 135(4): 983 - 990.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
R. D. Lopes, K. P. Alexander, S. V. Manoukian, M. E. Bertrand, F. Feit, H. D. White, C. V. Pollack Jr, J. Hoekstra, B. J. Gersh, G. W. Stone, et al.
Advanced Age, Antithrombotic Strategy, and Bleeding in Non-ST-Segment Elevation Acute Coronary Syndromes: Results From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial
J. Am. Coll. Cardiol., March 24, 2009; 53(12): 1021 - 1030.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
A. Budaj, J. W. Eikelboom, S. R. Mehta, R. Afzal, S. Chrolavicius, J.-P. Bassand, K. A.A. Fox, L. Wallentin, R. J.G. Peters, C. B. Granger, et al.
Improving clinical outcomes by reducing bleeding in patients with non-ST-elevation acute coronary syndromes
Eur. Heart J., March 2, 2009; 30(6): 655 - 661.
[Abstract] [Full Text] [PDF]

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 Mayo Clin Proc.Home page
M. Cohen
Expanding the Recognition and Assessment of Bleeding Events Associated With Antiplatelet Therapy in Primary Care
Mayo Clin. Proc., February 1, 2009; 84(2): 149 - 160.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
C. Medi, G. Montalescot, A. Budaj, K. A.A. Fox, J. Lopez-Sendon, G. FitzGerald, D. B. Brieger, and on behalf of the GRACE Investigators
Reperfusion in Patients With Renal Dysfunction After Presentation With ST-Segment Elevation or Left Bundle Branch Block: GRACE (Global Registry of Acute Coronary Events)
J. Am. Coll. Cardiol. Intv., January 1, 2009; 2(1): 26 - 33.
[Abstract] [Full Text] [PDF]

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 HeartHome page
T Kinnaird, R Anderson, J Hill, and M Thomas
Bleeding during percutaneous intervention: tailoring the approach to minimise risk
Heart, January 1, 2009; 95(1): 15 - 19.
[Abstract] [Full Text] [PDF]

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 HeartHome page
M. Hamon and J. Nolan
Should radial artery access be the "gold standard" for PCI?
Heart, December 1, 2008; 94(12): 1530 - 1532.
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 CirculationHome page
T. Y. Wang, L. Xiao, K. P. Alexander, S. V. Rao, M. N. Kosiborod, J. S. Rumsfeld, J. A. Spertus, and E. D. Peterson
Antiplatelet Therapy Use After Discharge Among Acute Myocardial Infarction Patients With In-Hospital Bleeding
Circulation, November 18, 2008; 118(21): 2139 - 2145.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
P. Agostoni, L. Testa, and G. G.L. Biondi-Zoccai
Comment on 'Comparison of operator radiation exposure with optimized radiation protection devices during coronary angiograms and ad hoc percutaneous coronary interventions by radial and femoral routes'
Eur. Heart J., November 2, 2008; 29(22): 2820 - 2821.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
E. Stabile, W. Nammas, L. Salemme, G. Sorropago, A. Cioppa, T. Tesorio, V. Ambrosini, E. Campopiano, G. Popusoi, G. Biondi Zoccai, et al.
The CIAO (Coronary Interventions Antiplatelet-based Only) Study: A Randomized Study Comparing Standard Anticoagulation Regimen to Absence of Anticoagulation for Elective Percutaneous Coronary Intervention
J. Am. Coll. Cardiol., October 14, 2008; 52(16): 1293 - 1298.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
O. F. Bertrand, J. Arsenault, and R. Mongrain
Operator vs. patient radiation exposure in transradial and transfemoral coronary interventions
Eur. Heart J., October 2, 2008; 29(20): 2577 - 2578.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
H. D. White, E. M. Ohman, A. M. Lincoff, M. E. Bertrand, A. Colombo, B. T. McLaurin, D. A. Cox, S. J. Pocock, J. A. Ware, S. V. Manoukian, et al.
Safety and Efficacy of Bivalirudin With and Without Glycoprotein IIb/IIIa Inhibitors in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Trial
J. Am. Coll. Cardiol., September 2, 2008; 52(10): 807 - 814.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
S. V. Rao, F.-S. Ou, T. Y. Wang, M. T. Roe, R. Brindis, J. S. Rumsfeld, and E. D. Peterson
Trends in the Prevalence and Outcomes of Radial and Femoral Approaches to Percutaneous Coronary Intervention: A Report From the National Cardiovascular Data Registry
J. Am. Coll. Cardiol. Intv., August 1, 2008; 1(4): 379 - 386.
[Abstract] [Full Text] [PDF]

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 HeartHome page
A J Chase, E B Fretz, W P Warburton, W P Klinke, R G Carere, D Pi, B Berry, and J D Hilton
Association of the arterial access site at angioplasty with transfusion and mortality: the M.O.R.T.A.L study (Mortality benefit Of Reduced Transfusion after percutaneous coronary intervention via the Arm or Leg)
Heart, August 1, 2008; 94(8): 1019 - 1025.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol., June 17, 2008; 51(24): 2355 - 2369.
[Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
R. J. Applegate, M. T. Sacrinty, M. A. Kutcher, F. R. Kahl, S. K. Gandhi, R. M. Santos, and W. C. Little
Trends in Vascular Complications After Diagnostic Cardiac Catheterization and Percutaneous Coronary Intervention Via the Femoral Artery, 1998 to 2007
J. Am. Coll. Cardiol. Intv., June 1, 2008; 1(3): 317 - 326.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
H. D. White, D. P. Chew, J. W. Hoekstra, C. D. Miller, C. V. Pollack Jr, F. Feit, A. M. Lincoff, M. Bertrand, S. Pocock, J. Ware, et al.
Safety and Efficacy of Switching From Either Unfractionated Heparin or Enoxaparin to Bivalirudin in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Managed With an Invasive Strategy: Results From the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Trial
J. Am. Coll. Cardiol., May 6, 2008; 51(18): 1734 - 1741.
[Abstract] [Full Text] [PDF]

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 HeartHome page
J.-P. Bassand
Bleeding and transfusion in acute coronary syndromes: a shift in the paradigm
Heart, May 1, 2008; 94(5): 661 - 666.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
F. Feit, S. V. Manoukian, R. Ebrahimi, C. V. Pollack, E. M. Ohman, M. J. Attubato, R. Mehran, and G. W. Stone
Safety and Efficacy of Bivalirudin Monotherapy in Patients With Diabetes Mellitus and Acute Coronary Syndromes: A Report From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial
J. Am. Coll. Cardiol., April 29, 2008; 51(17): 1645 - 1652.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
G. Ndrepepa, P. B. Berger, J. Mehilli, M. Seyfarth, F.-J. Neumann, A. Schomig, and A. Kastrati
Periprocedural Bleeding and 1-Year Outcome After Percutaneous Coronary Interventions: Appropriateness of Including Bleeding as a Component of a Quadruple End Point
J. Am. Coll. Cardiol., February 19, 2008; 51(7): 690 - 697.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
H. L. Dauerman
Percutaneous Coronary Intervention Pharmacology: From a Triangle to a Square
J. Am. Coll. Cardiol., February 19, 2008; 51(7): 698 - 700.
[Full Text] [PDF]

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 CirculationHome page
P. B. Berger and S. V. Manoukian
Bleeding Is Bad.... Isn't It?
Circulation, December 11, 2007; 116(24): 2776 - 2778.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
R. P. Giugliano and E. Braunwald
The Year in Non ST-Segment Elevation Acute Coronary Syndrome
J. Am. Coll. Cardiol., October 2, 2007; 50(14): 1386 - 1395.
[Full Text] [PDF]


 
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