CLINICAL RESEARCH
A Comparison of the Clinical Impact of Bleeding Measured by Two Different Classifications Among Patients With Acute Coronary Syndromes
Sunil V. Rao, MD*,*,
Kristi O'Grady, MS*,
Karen S. Pieper, MS*,
Christopher B. Granger, MD, FACC*,
L. Kristin Newby, MD, MHS, FACC*,
Kenneth W. Mahaffey, MD, FACC*,
David J. Moliterno, MD, FACC ,
A. Michael Lincoff, MD, FACC ,
Paul W. Armstrong, MD, FACC ,
Frans Van de Werf, MD, FACC||,
Robert M. Califf, MD, FACC* and
Robert A. Harrington, MD, FACC*
* Duke Clinical Research Institute, Durham, North Carolina
University of Kentucky, Lexington, Kentucky
Cleveland Clinic Foundation, Cleveland, Ohio
University of Alberta, Edmonton, Alberta, Canada
|| Universitaire Ziekenhuizen Leuven, Leuven, Belgium
Manuscript received February 17, 2005;
revised manuscript received August 26, 2005,
accepted September 9, 2005.
* Reprint requests and correspondence: Dr. Sunil V. Rao, The Duke Clinical Research Institute, P.O. Box 17969, Durham, North Carolina 27715. (Email: sunil.rao{at}duke.edu).
OBJECTIVES: The goal of this study was to determine the association between Thrombolysis In Myocardial Infarction (TIMI) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding and clinical outcomes.
BACKGROUND: There are limited data on the relative utility of either scale at predicting clinical outcomes in patients with non–ST-segment elevation acute coronary syndromes (ACS).
METHODS: Pooled data from two randomized trials of patients with ACS (n = 15,454) were analyzed to determine the association between TIMI and GUSTO bleeding and 30-day and 6-month death/myocardial infarction (MI) using Cox proportional hazards modeling that included bleeding as a time-dependent covariate.
RESULTS: There was a stepwise increase in the adjusted hazard of 30-day death/MI with worsening GUSTO bleeding (hazard ratio [95% confidence interval], GUSTO mild 1.20 [1.05 to 1.37]; moderate 3.28 [2.88 to 3.73]; severe 5.57 [4.33 to 7.17]), and an increased risk with all three levels of TIMI bleeding (TIMI minimal 1.84 [1.63 to 2.08]; TIMI minor 1.64 [1.31 to 2.04]; major 1.45 [1.23 to 1.70]). When both bleeding scales were included in the same model, the risk with GUSTO bleeding persisted; however, the association between TIMI bleeding and outcome was no longer significant.
CONCLUSIONS: Both scales identify ACS patients with bleeding complications at risk for adverse outcomes. In a model that included both definitions, the risk with GUSTO bleeding persisted while the risk with TIMI bleeding did not. This suggests that bleeding assessed with clinical criteria is more important than that assessed by laboratory criteria in terms of outcomes. Future clinical trials should consider using a combination of the GUSTO bleeding scale and the need for transfusion to assess bleeding complications.
This article has been cited by other articles:
|
|
|
|
 
A. Marzocchi, A. Manari, G. Piovaccari, C. Marrozzini, S. Marra, P. Magnavacchi, P. Sangiorgio, L. Marinucci, N. Taglieri, G. Gordini, et al.
Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial
Eur. Heart J.,
October 21, 2008;
(2008)
ehn467v1.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. V. Rao and S. Y.H. Kim
Informing the Consent Process
Circ Cardiovasc Qual Outcomes,
September 1, 2008;
1(1):
7 - 8.
[Full Text]
[PDF]
|
|
|
|
|
|
|
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]
|
|
|
|
|
|
|
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]
|
|
|
|
|
|
|
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]
|
|
|
|
|
|
|
P. B. Berger and S. V. Manoukian
Bleeding Is Bad.... Isn't It?
Circulation,
December 11, 2007;
116(24):
2776 - 2778.
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. V. Rao, J. A. Eikelboom, C. B. Granger, R. A. Harrington, R. M. Califf, and J.-P. Bassand
Bleeding and blood transfusion issues in patients with non-ST-segment elevation acute coronary syndromes
Eur. Heart J.,
May 2, 2007;
28(10):
1193 - 1204.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. V. Manoukian, F. Feit, R. Mehran, M. D. Voeltz, R. Ebrahimi, M. Hamon, G. D. Dangas, A. M. Lincoff, H. D. White, J. W. Moses, et al.
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.,
March 27, 2007;
49(12):
1362 - 1368.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. W. Mahaffey and R. A. Harrington
Optimal Timing for Use of Glycoprotein IIb/IIIa Inhibitors in Acute Coronary Syndromes: Questions, Answers, and More Questions
JAMA,
February 14, 2007;
297(6):
636 - 639.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. W. Eikelboom and J. Hirsh
Bleeding and management of bleeding
Eur. Heart J. Suppl.,
October 1, 2006;
8(suppl_G):
G38 - G45.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. W. Eikelboom, S. R. Mehta, S. S. Anand, C. Xie, K. A.A. Fox, and S. Yusuf
Adverse Impact of Bleeding on Prognosis in Patients With Acute Coronary Syndromes
Circulation,
August 22, 2006;
114(8):
774 - 782.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
