HOME SUBSCRIPTIONS CURRENT ISSUE PAST ISSUES CARDIOSOURCE SEARCH HELP FEEDBACK		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Figures Only Full Text Full Text (PDF) View Online Appendix View Online Video Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Related articles in JACC Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (18) Citing Articles via Google Scholar Google Scholar Articles by Gibson, C. M. Search for Related Content PubMed PubMed Citation Articles by Gibson, C. M.

CLINICAL RESEARCH: CLINICAL TRIAL

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^,1, Lisa K. Jennings, PhD^,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
Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts
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.

Manuscript received May 6, 2005; revised manuscript received November 23, 2005, accepted December 1, 2005.

^_* Reprint requests and correspondence: Dr. C. Michael Gibson, 350 Longwood Avenue, First Floor, Boston Massachusetts 02115. (Email: mgibson{at}timi.org).

OBJECTIVES: The goal of this study was to evaluate glycoprotein IIb/IIIa inhibition with eptifibatide when administered with indirect thrombin inhibition as compared with monotherapy with direct thrombin inhibition with bivalirudin among patients with non–ST-segment elevation acute coronary syndromes (ACS).

BACKGROUND: The optimal combination of antiplatelet and antithrombin regimens that maximizes efficacy and minimizes bleeding among patients with non–ST-segment elevation ACS undergoing percutaneous coronary intervention (PCI) is unclear.

METHODS: A total of 857 patients with non–ST-segment elevation ACS were assigned randomly to eptifibatide + reduced dose unfractionated heparin (n = 298), eptifibatide + reduced-dose enoxaparin (n = 275), or bivalirudin monotherapy (n = 284).

RESULTS: Among angiographically evaluable patients (n = 754), the primary end point of post-PCI coronary flow reserve was significantly greater with bivalirudin (1.43 vs. 1.33 for pooled eptifibatide arms, p = 0.036). Thrombolysis In Myocardial Infarction (TIMI) myocardial perfusion grade more often was normal with eptifibatide treatment compared with bivalirudin (57.9% vs. 50.9%, p = 0.048). The duration of ischemia on continuous Holter monitoring after PCI was significantly longer among patients treated with bivalirudin (169 vs. 36 min, p = 0.013). There was no excess of TIMI major bleeding among patients treated with eptifibatide compared with bivalirudin (0.7%, n = 4 vs. 0%, p = NS), but TIMI minor bleeding was increased (2.5% vs. 0.4%, p = 0.027) as was transfusion (4.4% to 0.4%, p < 0.001).

CONCLUSIONS: Among moderate- to high-risk patients with ACS undergoing PCI, coronary flow reserve was greater with bivalirudin than eptifibatide. Eptifibatide improved myocardial perfusion and reduced the duration of post-PCI ischemia but was associated with higher minor bleeding and transfusion rates. Ischemic events and biomarkers for myonecrosis, inflammation, and thrombin generation did not differ between agents.

Abbreviations and Acronyms   ACT = activated clotting time   CK-MB = creatine kinase-myocardial band   CTFC = corrected TIMI frame count   GP = glycoprotein   IL = interleukin   IV = intravenous   MI = myocardial infarction   NSTEMI = non–ST-segment elevation myocardial infarction   PCI = percutaneous coronary intervention   TIMI = Thrombolysis In Myocardial Infarction   TMPG = TIMI myocardial perfusion grade   UFH = unfractionated heparin

Related articles in JACC:

The Future of an Illusion

John A. Bittl
JACC 2006 47: 2380-2383. [Full Text]  

This article has been cited by other articles:

				A. R. Pries, H. Habazettl, G. Ambrosio, P. R. Hansen, J. C. Kaski, V. Schachinger, H. Tillmanns, G. Vassalli, I. Tritto, M. Weis, et al. A review of methods for assessment of coronary microvascular disease in both clinical and experimental settings Cardiovasc Res, June 25, 2008; (2008) cvn136v2. [Abstract] [Full Text] [PDF]

				S. G. Goodman, V. Menon, C. P. Cannon, G. Steg, E. M. Ohman, and R. A. Harrington Acute ST-Segment Elevation Myocardial Infarction: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) Chest, June 1, 2008; 133(6_suppl): 708S - 775S. [Abstract] [Full Text] [PDF]

				R. Dumaine, M. Borentain, O. Bertel, C. Bode, R. Gallo, H. D. White, J.-P. Collet, S. R. Steinhubl, and G. Montalescot Intravenous Low-Molecular-Weight Heparins Compared With Unfractionated Heparin in Percutaneous Coronary Intervention: Quantitative Review of Randomized Trials Arch Intern Med, December 10, 2007; 167(22): 2423 - 2430. [Abstract] [Full Text] [PDF]

				S. R. Dixon, C. L. Grines, and W. W. O'Neill The Year in Interventional Cardiology J. Am. Coll. Cardiol., July 17, 2007; 50(3): 270 - 285. [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]

				C. M. Gibson and E. Braunwald Reply J. Am. Coll. Cardiol., February 13, 2007; 49(6): 730 - 731. [Full Text] [PDF]

				M. Valgimigli, G. G.L. Biondi-Zoccai, and P. Agostoni Clinical Implications of the PROTECT-TIMI-30 Trial J. Am. Coll. Cardiol., February 13, 2007; 49(6): 729 - 730. [Full Text] [PDF]

				J.-P. Collet, R. Dumaine, and G. Montalescot Antithrombin treatment in patients with non-ST-elevation acute coronary syndromes undergoing percutaneous coronary intervention Eur. Heart J. Suppl., February 1, 2007; 9(suppl_A): A11 - A24. [Abstract] [Full Text] [PDF]

				D. Antoniucci Differences among GP IIb/IIIa inhibitors: different clinical benefits in non-ST-segment elevation acute coronary syndrome percutaneous coronary intervention patients Eur. Heart J. Suppl., February 1, 2007; 9(suppl_A): A32 - A36. [Abstract] [Full Text] [PDF]

				J. A. Bittl Accounting for ACUITY. N. Engl. J. Med., November 23, 2006; 355(21): 2249 - 2250. [Full Text] [PDF]

				Eptifibatide vs. Bivalirudin for PCI in UA/NSTEMI Journal Watch Cardiology, July 19, 2006; 2006(719): 3 - 3. [Full Text]

				J. A. Bittl The Future of an Illusion J. Am. Coll. Cardiol., June 20, 2006; 47(12): 2380 - 2383. [Full Text] [PDF]