(Circulation. 1997;96:1445-1453.)
© 1997 American Heart Association, Inc.
Articles |
Effects of Platelet Glycoprotein IIb/IIIa Blockade With Tirofiban on Adverse Cardiac Events in Patients With Unstable Angina or Acute Myocardial Infarction Undergoing Coronary Angioplasty
Correspondence to Spencer B. King III, MD, Emory University Hospital–F606, 1364 Clifton Rd, Atlanta, GA 30322-1104.
Background Adverse cardiovascular events associated with thrombotic occlusion occur in 4% to 12.8% of patients after coronary angioplasty. Recently, potent antiplatelet agents have been used to reduce those thrombotic complications. Tirofiban is a highly selective, short-acting inhibitor of fibrinogen binding to platelet glycoprotein (GP) IIb/IIIa that inhibits ex vivo platelet aggregation in response to a variety of agonists.
Methods and Results The RESTORE trial (Randomized Efficacy
Study of Tirofiban for Outcomes and REstenosis) was a
randomized, double-blind, placebo-controlled trial of tirofiban in
patients undergoing coronary interventions (balloon angioplasty
or directional atherectomy) within 72 hours of presentation
with an acute coronary syndrome (unstable angina pectoris or
acute myocardial infarction). The end points of the study were death
from any cause, myocardial infarction, coronary bypass surgery
due to angioplasty failure or recurrent ischemia, repeat
target-vessel angioplasty for recurrent ischemia, and insertion
of a stent due to actual or threatened abrupt closure of the dilated
artery, and the primary end point was a composite
representing the occurrence of any of these events. The
prespecified primary hypothesis of the study was that tirofiban,
administered as a bolus of 10 µg/kg over a 3-minute period and
followed by a 36-hour infusion of 0.15 µg ·
kg-1 · min-1,
would result in a reduction in the 30-day composite end point compared
with placebo. Patients (n=2139) who were already receiving treatment
with aspirin and heparin were randomized to receive tirofiban or
placebo. The primary composite end point at 30 days was reduced from
12.2% in the placebo group to 10.3% in the tirofiban group, a 16%
relative reduction (P=.160). However, 2 days after
angioplasty, the tirofiban group had a 38% relative reduction in the
composite end point (P
.005), and at 7 days there was a
27% relative reduction (P=.022), largely because of a reduction in
nonfatal myocardial infarction and the need for repeat angioplasty.
When repeat angioplasty or coronary artery bypass surgery
procedures were included in the composite only if performed on an
urgent or emergency basis, the composite 30-day event rates were 10.5%
for the placebo group and 8.0% for the tirofiban group, a relative
reduction of 24% (P=.052). Major bleeding, including
transfusion, was not significantly different between the two groups
(3.7% in the placebo group and 5.3% in the tirofiban group;
P=.096). When the Thrombolysis In Myocardial
Infarction (TIMI) criteria for major bleeding were used, the incidence
was 2.1% in the placebo group compared with 2.4% in the tirofiban
group (P=.662). Thrombocytopenia was similar in the placebo
and tirofiban groups (0.9% for the placebo group versus 1.1% for the
tirofiban group; P=.709).
Conclusions In patients undergoing coronary angioplasty for acute coronary syndromes, tirofiban protects against early adverse cardiac events related to thrombotic closure. At 30 days, however, the reduction in adverse cardiac events was no longer statistically significant. The bleeding observed with tirofiban was not statistically different from that observed with placebo.
Key Words: angioplasty • platelets • glycoproteins • receptors
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J.P. Ottervanger, P. Armstrong, E.S. Barnathan, E. Boersma, J.S. Cooper, E.M. Ohman, S. James, E. Topol, L. Wallentin, M.L. Simoons, et al. Long-Term Results After the Glycoprotein IIb/IIIa Inhibitor Abciximab in Unstable Angina: One-Year Survival in the GUSTO IV-ACS (Global Use of Strategies To Open Occluded Coronary Arteries IV--Acute Coronary Syndrome) Trial Circulation, January 28, 2003; 107(3): 437 - 442. [Abstract] [Full Text] [PDF]
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E. Karvouni, D. G. Katritsis, and J. P. A. Ioannidis Intravenous glycoprotein IIb/IIIa receptor antagonists reduce mortality after percutaneous coronary interventions J. Am. Coll. Cardiol., January 1, 2003; 41(1): 26 - 32. [Abstract] [Full Text] [PDF]
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R. K. Yarlagadda and W. E. Boden Cardioprotective effects of an early invasive strategy for non-ST-segment elevationacute coronary syndromes: Are we all becoming "interventional" cardiologists? J. Am. Coll. Cardiol., December 4, 2002; 40(11): 1915 - 1918. [Full Text] [PDF]
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M. E. Bertrand, M. L. Simoons, K. A.A. Fox, L. C. Wallentin, C. W. Hamm, E. McFadden, P. J. De Feyter, G. Specchia, and W. Ruzyllo Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation Eur. Heart J., December 1, 2002; 23(23): 1809 - 1840. [Full Text] [PDF]
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W. B. Batchelor, T. R. Tolleson, Y. Huang, R. L. Larsen, R. M. Mantell, P. Dillard, M. Davidian, D. Zhang, W. J. Cantor, M. H. Sketch Jr, et al. Randomized COMparison of Platelet Inhibition With Abciximab, TiRofiban and Eptifibatide During Percutaneous Coronary Intervention in Acute Coronary Syndromes: The COMPARE Trial Circulation, September 17, 2002; 106(12): 1470 - 1476. [Abstract] [Full Text] [PDF]
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E.M. Antman 'I can see clearly now': a new view on the use of IV GP IIb/IIIa inhibitors in acute coronary syndromes Eur. Heart J., September 2, 2002; 23(18): 1408 - 1411. [Full Text] [PDF]
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A. W. Bonz, B. Lengenfelder, J.o. Strotmann, S. Held, O. Turschner, K. Harre, C. Wacker, C. Waller, N. Kochsiek, M. Meesmann, et al. effect of additional temporary glycoprotein IIb/IIIa receptor inhibition on troponin release in elective percutaneous coronary interventions after pretreatment with aspirin and clopidogrel (TOPSTAR trial) J. Am. Coll. Cardiol., August 21, 2002; 40(4): 662 - 668. [Abstract] [Full Text] [PDF]
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M. J. Quinn, E. F. Plow, and E. J. Topol Platelet Glycoprotein IIb/IIIa Inhibitors: Recognition of a Two-Edged Sword? Circulation, July 16, 2002; 106(3): 379 - 385. [Full Text] [PDF]
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D.J. Moliterno and E.J. Topol The TARGET trial: hit or miss? Eur. Heart J., June 1, 2002; 23(11): 835 - 837. [Full Text] [PDF]
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G. W. Stone, D. J. Moliterno, M. Bertrand, F.-J. Neumann, H. C. Herrmann, E. R. Powers, C. L. Grines, J. W. Moses, D. J. Cohen, E. A. Cohen, et al. Impact of Clinical Syndrome Acuity on the Differential Response to 2 Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Coronary Stenting: The TARGET Trial* Circulation, May 21, 2002; 105(20): 2347 - 2354. [Abstract] [Full Text] [PDF]
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P.J. de Feyter, P.W. Serruys, F. Unger, R. Beyar, V. de Valk, S. Milo, R. Simon, D. Regensburger, P.A. Crean, E. McGovern, et al. Bypass Surgery Versus Stenting for the Treatment of Multivessel Disease in Patients With Unstable Angina Compared With Stable Angina Circulation, May 21, 2002; 105(20): 2367 - 2372. [Abstract] [Full Text] [PDF]
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F.W.G. Leebeek, E. Boersma, C.P. Cannon, F.J.J. van de Werf, and M.L. Simoons Oral glycoprotein IIb/IIIa receptor inhibitors in patients with cardiovascular disease: why were the results so unfavourable Eur. Heart J., March 2, 2002; 23(6): 444 - 457. [Full Text] [PDF]
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J. C. O'Shea, C. E. Buller, W. J. Cantor, A. B. Chandler, E. A. Cohen, D. J. Cohen, I. C. Gilchrist, N. S. Kleiman, M. Labinaz, M. Madan, et al. Long-term Efficacy of Platelet Glycoprotein IIb/IIIa Integrin Blockade With Eptifibatide in Coronary Stent Intervention JAMA, February 6, 2002; 287(5): 618 - 621. [Abstract] [Full Text] [PDF]
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R.E. Brown, R.A. Henderson, D. Koster, J. Hutton, and M.L. Simoons Cost effectiveness of eptifibatide in acute coronary syndromes. An economic analysis of Western European patients enrolled in the PURSUIT trial Eur. Heart J., January 1, 2002; 23(1): 50 - 58. [Abstract] [Full Text] [PDF]
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F. Bizzarri, S. Scolletta, E. Tucci, M. Lucidi, G. Davoli, T. Toscano, E. Neri, L. Muzzi, and G. Frati Perioperative use of tirofiban hydrochloride (Aggrastat) does not increase surgical bleeding after emergency or urgent coronary artery bypass grafting J. Thorac. Cardiovasc. Surg., December 1, 2001; 122(6): 1181 - 1185. [Abstract] [Full Text] [PDF]
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W. R. P. Agema, J. W. Jukema, S. N. Pimstone, and J. J. P. Kastelein Genetic aspects of restenosis after percutaneous coronary interventions;towards more tailored therapy Eur. Heart J., November 2, 2001; 22(22): 2058 - 2074. [PDF]
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J.E. Tcheng, J. Strony, T.J. Lorenz, and J.C. O'Shea ESPRIT in context: pharmacology matters! Eur. Heart J., November 1, 2001; 22(21): 1965 - 1967. [PDF]
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J. Schweizer, A. Muller, L. Forkmann, G. Hellner, and W. Kirch Potential Use of a Low-Molecular-Weight Heparin to Prevent Restenosis in Patients with Extensive Wall Damage Following Peripheral Angioplasty Angiology, October 1, 2001; 52(10): 659 - 669. [Abstract] [PDF]
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G. GONZI, P. A. MERLINI, and D. ARDISSINO Invasive coronary revascularisation is better than conservative treatment in patients with acute coronary syndromes Heart, October 1, 2001; 86(4): 363 - 364. [Full Text] [PDF]
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M. Genoni, D. Zeller, O. Bertel, M. Maloigne, and M. Turina Tirofiban therapy does not increase the risk of hemorrhage after emergency coronary surgery J. Thorac. Cardiovasc. Surg., September 1, 2001; 122(3): 630 - 632. [Full Text] [PDF]
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E. Giannitsis, M. Muller-Bardorff, S. Lehrke, U. Wiegand, R. Tolg, B. Weidtmann, F. Hartmann, G. Richardt, and H. A. Katus Admission Troponin T Level Predicts Clinical Outcomes, TIMI Flow, and Myocardial Tissue Perfusion After Primary Percutaneous Intervention for Acute ST-Segment Elevation Myocardial Infarction Circulation, August 7, 2001; 104(6): 630 - 635. [Abstract] [Full Text] [PDF]
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W.S. Weintraub Economics of coronary stenting and GPIIb/IIIa blockade Eur. Heart J., August 2, 2001; 22(16): 1366 - 1368. [PDF]
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S. S. Kabbani, M. W. Watkins, T. Ashikaga, E. F. Terrien, P. A. Holoch, B. E. Sobel, and D. J. Schneider Platelet Reactivity Characterized Prospectively: A Determinant of Outcome 90 Days After Percutaneous Coronary Intervention Circulation, July 10, 2001; 104(2): 181 - 186. [Abstract] [Full Text] [PDF]
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K. M. Akkerhuis, J. W. Deckers, A. M. Lincoff, J. E. Tcheng, E. Boersma, K. Anderson, C. Balog, R. M. Califf, E. J. Topol, and M. L. Simoons Risk of Stroke Associated With Abciximab Among Patients Undergoing Percutaneous Coronary Intervention JAMA, July 4, 2001; 286(1): 78 - 82. [Abstract] [Full Text] [PDF]
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K. M. Anderson, R. M. Califf, G. W. Stone, F.-J. Neumann, G. Montalescot, D. P. Miller, J. J. Ferguson III, J. T. Willerson, H. F. Weisman, and E. J. Topol Long-term mortality benefit with abciximab in patients undergoing percutaneous coronary intervention J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2059 - 2065. [Abstract] [Full Text] [PDF]
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S. C. Smith Jr, J. T. Dove, A. K. Jacobs, J. Ward Kennedy, D. Kereiakes, M. J. Kern, R. E. Kuntz, J. J. Popma, H. V. Schaff, D. O. Williams, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines): A report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2239 - 2239. [Full Text] [PDF]
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E. Braunwald Foreword Eur. Heart J. Suppl., May 1, 2001; 3(suppl_A): A1 - A2. [PDF]
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C.W. Hamm GP IIb/IIIa receptor antagonists in unstable angina: troponin level-based patient selection Eur. Heart J. Suppl., May 1, 2001; 3(suppl_A): A14 - A20. [Abstract] [PDF]
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K M Akkerhuis, M J B M van den Brand, C van der Zwaan, H O J Peels, H Suryapranata, L R van der Wieken, J Stibbe, J Hoffmann, T Baardman, J W Deckers, et al. Pharmacodynamics and safety of lefradafiban, an oral platelet glycoprotein IIb/IIIa receptor antagonist, in patients with stable coronary artery disease undergoing elective angioplasty Heart, April 1, 2001; 85(4): 444 - 450. [Abstract] [Full Text]
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