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(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

The RESTORE Investigators¹

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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				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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				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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				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]

				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]

				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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				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]

				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]

				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]

				W.S. Weintraub Economics of coronary stenting and GPIIb/IIIa blockade Eur. Heart J., August 2, 2001; 22(16): 1366 - 1368. [PDF]

				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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				M. S. Williams and P. F. Bray Genetics of Arterial Prothrombotic Risk States Experimental Biology and Medicine, May 1, 2001; 226(5): 409 - 419. [Abstract] [Full Text]