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J Am Coll Cardiol, 2006; 47:2364-2373, doi:10.1016/j.jacc.2005.12.077
© 2006 by the American College of Cardiology Foundation
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A Randomized Trial to Evaluate the Relative Protection Against Post-Percutaneous Coronary Intervention Microvascular Dysfunction, Ischemia, and Inflammation Among Antiplatelet and Antithrombotic Agents

The PROTECT–TIMI-30 Trial

C. Michael Gibson, MS, MD*,3,*, David A. Morrow, MD, MPH*, Sabina A. Murphy, MPH*, Theresa M. Palabrica, MD{dagger},1, Lisa K. Jennings, PhD{ddagger},4, Peter H. Stone, MD*, Henry H. Lui, MD§, Thomas Bulle, MD||, Nasser Lakkis, MD, Richard Kovach, MD#, David J. Cohen, MD, MSC**,2, Polly Fish, BS*, Carolyn H. McCabe, BS*, Eugene Braunwald, MD* for the TIMI Study Group

* TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital and Department of Medicine, Harvard Medical School, Boston, Massachusetts
{dagger} Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts
{ddagger} University of Tennessee, Knoxville, Tennessee
§ APEX Cardiology, Jackson, Tennessee
|| Cardiovascular Associates, Kingsport, Tennessee
Ben Taub Hospital, Houston, Texas
# Our Lady of Lourdes Medical Center, Camden, New Jersey
** Beth Israel Deaconess Medical Center, Boston, Massachusetts.


Figure 1
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Figure 1 Design of the PROTECT–TIMI-30 trial. ACT = activated clotting time; d/c = discontinued; IV = intravenous; IVB = intravenous bolus; PCI = percutaneous coronary intervention; UFH = unfractionated heparin.

 

Figure 2
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Figure 2 Among angiographically evaluable patients, the median coronary flow reserve was greater in the bivalirudin arm.

 

Figure 3
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Figure 3 The Thrombolysis In Myocardial Infarction myocardial perfusion grade (TMPG) 3 after percutaneous coronary intervention (PCI). The frequency of TMPG 3 after PCI was significantly greater in the eptifibatide group compared with the bivalirudin group. The p value has been adjusted for the pre-PCI TMPG 3 as prespecified. The univariate p = 0.074.

 

Figure 4
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Figure 4 Incidence and duration of ischemia on Holter monitoring after percutaneous coronary intervention. Among patients with an ischemic event after percutaneous coronary intervention, the median duration of ischemia was significantly longer in the bivalirudin group compared with the eptifibatide group.

 

Figure 5
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Figure 5 Death (D), myocardial infarction (MI), or ischemia on Holter monitoring through 48 h. The composite event of D, MI, or ischemia on Holter monitoring through 48 h occurred in 18% of the bivalirudin arm compared with 14.2% of the pooled eptifibatide arms (odds ratio [OR] 1.35, 95% confidence interval [CI] 0.91 to 2.01, p = 0.150), whereas the composite of D or MI occurred in 8.8% and 6.6%, respectively (OR 1.37, 95% CI 0.81 to 2.31, p = 0.246). One patient in the eptifibatide arm died outside of the 48-h window (at 3 days after randomization) secondary to a retroperitoneal bleed.

 

Figure 6
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Figure 6 Incidence of Thrombolysis In Myocardial Infarction (TIMI) major hemorrhage. The rate of TIMI major hemorrhage, the primary safety end point, did not differ between the eptifibatide (EPT, pooled) and bivalirudin (BIV) treatment groups. ENOX = reduced-dose enoxaparin.

 

Figure 7
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Figure 7 Incidence of transfusion. The rate of transfusion occurred significantly more frequently in the eptifibatide (EPT) arms compared with the bivalirudin (BIV) treatment group. ENOX =reduced-dose enoxaparin; UFH = unfractionated heparin.

 





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