(Circulation. 1999;100:2045-2048.)
© 1999 American Heart Association, Inc.
Brief Rapid Communication |
Platelet Glycoprotein IIb/IIIa Receptor Inhibition in Non–ST-Elevation Acute Coronary Syndromes
Early Benefit During Medical Treatment Only, With Additional Protection During Percutaneous Coronary Intervention
From the Thoraxcenter, University Hospital Rotterdam, Netherlands (E.B., K.M.A., M.L.S.); the University of Montreal, Canada (P.T.); Duke Clinical Research Institute, Durham, NC (R.M.C.); and the Cleveland Clinic Foundation, Cleveland, Ohio (E.J.T.).
Correspondence to Eric Boersma, University Hospital Rotterdam, Room H543, Dr Molewaterplein 40, 3015 GD Rotterdam, Netherlands. E-mail boersma{at}thch.azr.nl
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Abstract |
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 Top Abstract IntroductionReferences |
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Background—Glycoprotein (GP) IIb/IIIa receptor blockers prevent life-threatening cardiac complications in patients with acute coronary syndromes without ST-segment elevation and protect against thrombotic complications associated with percutaneous coronary interventions (PCIs). The question arises as to whether these 2 beneficial effects are independent and additive.
Methods and Results—We analyzed data from the CAPTURE, PURSUIT, and PRISM-PLUS randomized trials, which studied the effects of the GP IIb/IIIa inhibitors abciximab, eptifibatide, and tirofiban, respectively, in acute coronary syndrome patients without persistent ST-segment elevation, with a period of study drug infusion before a possible PCI. During the period of pharmacological treatment, each trial demonstrated a significant reduction in the rate of death or nonfatal myocardial infarction in patients randomized to the GP IIb/IIIa inhibitor compared with placebo. The 3 trials combined showed a 2.5% event rate in this period in the GP IIb/IIIa inhibitor group (N=6125) versus 3.8% in placebo (N=6171), which implies a 34% relative reduction (P<0.001). During study medication, a PCI was performed in 1358 patients assigned GP IIb/IIIa inhibition and 1396 placebo patients. The event rate during the first 48 hours after PCI was also significantly lower in the GP IIb/IIIa inhibitor group (4.9% versus 8.0%; 41% reduction; P<0.001). No further benefit or rebound effect was observed beyond 48 hours after the PCI.
Conclusions—There is conclusive evidence of an early benefit of GP IIb/IIIa inhibitors during medical treatment in patients with acute coronary syndromes without persistent ST-segment elevation. In addition, in patients subsequently undergoing PCI, GP IIb/IIIa inhibition protects against myocardial damage associated with the intervention.
Key Words: coronary disease • glycoproteins • intervention
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Introduction |
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TopAbstractIntroductionReferences |
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Coronary thrombosis is a pivotal event in the pathogenesis of acute coronary syndromes and ischemic complications resulting from coronary interventions.1 Activation of the platelet glycoprotein (GP) IIb/IIIa receptor is the final common pathway in the process leading to platelet aggregation, coronary thrombus formation, and myocardial ischemia. Accordingly, inhibitors of platelet GP IIb/IIIa are potent agents to prevent progression to myocardial infarction (MI) and death.2 Indeed, in recent randomized clinical trials, GP IIb/IIIa inhibitors effectively reduced life-threatening complications in patients with acute coronary syndromes without ST-segment elevation.3 4 Furthermore, these agents protect against life-threatening thrombotic complications associated with percutaneous coronary intervention (PCI).5 The question arises as to whether these 2 beneficial effects are independent and additive. To date, 3 clinical trials can contribute to answering this question (Table 1
).3 4 6
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CAPTURE studied the effects of abciximab in patients with unstable
angina refractory to conventional medical therapy.6 A
reduction was observed in the rate of death or nonfatal MI during the
24-hour period of pharmacological treatment preceding PCI among
patients randomized to abciximab versus placebo (Kaplan-Meier estimates
1.3% versus 2.8%; log-rank P=0.032;
Figure). The event rate during the first
48 hours after PCI was significantly lower in abciximab patients (2.8%
versus 5.8% in placebo; P=0.009). In the period starting 48
hours after PCI, only a few events occurred, with similar rates in both
groups.
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Observations in PURSUIT confirmed these findings.3 Acute coronary syndrome patients randomized to eptifibatide had a 3.2% event rate after the scheduled 72 hours of study drug infusion, versus 4.4% in placebo (P=0.003). There were also fewer procedure-related events in eptifibatide patients undergoing a PCI during this period (7.6% versus 10.3% in placebo; P=0.105). In the subsequent postprocedural period (all patients were off study medication), event rates were low and similar in both groups.
PRISM-PLUS also confirmed the beneficial effects of GP IIb/IIIa inhibition before and during PCI.4 Patients assigned tirofiban had fewer events during initial medical management (1.8% versus 3.8% in placebo; P=0.016) as well as fewer PCI-related events (2.9% versus 8.0%; P=0.062).
There was no evidence of a differential effect of the GP IIb/IIIa
blockers between the trials, in any of the 3 stages, because all tests
for homogeneity of treatment effect were nonsignificant. Therefore, the
separate trial data could be combined (Figure
and Table 2). The 3 trials together demonstrated a
34% reduction in the composite of death or nonfatal MI during
pharmacological therapy preceding PCI (if any) by GP IIb/IIIa
inhibition [2.5% versus 3.8% in placebo; odds ratio (95% CI) 0.66
(0.54 to 0.81)] and an additional 41% reduction in PCI-related events
[4.9% versus 8.0%; odds ratio 0.59 (0.44 to 0.81)]. Mortality was
low but was still affected by GP IIb/IIIa inhibition. The incidence of
death during medical therapy was 0.4% among patients randomized to GP
IIb/IIIa inhibition compared with 0.7% among placebo patients [odds
ratio 0.50 (0.30 to 0.83)]. The procedure-related death rates were
0.5% and 0.8%, respectively [odds ratio 0.65 (0.25 to 1.69)].
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Intracoronary stents were used in 10.5% of the CAPTURE
patients. In PURSUIT and PRISM-PLUS, stenting was done in 50.2% and
20.3% of patients undergoing PCI during study drug infusion,
respectively. Irrespective of treatment assignment, the overall
procedure-related event rates were higher in‘ stented patients (9.3%
versus 5.3% in balloon angioplasty; 
2
P<0.001). However, the beneficial effect of GP IIb/IIIa
inhibition was similar in stented and balloon-only patients, with odds
ratios (95% CIs) of 0.61 (0.38 to 0.99) and 0.58 (0.38 to 0.88),
respectively (homogeneity test: P=0.863). Late event rates
were similar in patients with and without stents (1.6% versus 1.4%)
and were not influenced by the initial GP IIb/IIIa treatment.
In contrast to CAPTURE, in which all patients were to undergo PCI, in PURSUIT and PRISM-PLUS the decision to perform an intervention was at the discretion of the treating physician. Patients undergoing a PCI in these latter trials were possibly at higher-than-average risk. Indeed, compared with CAPTURE, procedure-related event rates in the placebo arms were higher than expected on the basis of the preprocedural event rates. These higher event rates, however, did not affect the benefit of GP IIb/IIIa blockade, because there was no evidence of a differential effect between the 3 trials. Still, the observed reduction in procedure-related events by GP IIb/IIIa treatment in PURSUIT and PRISM-PLUS might have been biased because of indistinct selection criteria. However, the incidence of PCI in both treatment arms of these trials was well balanced, as were the baseline characteristics of the patients concerned.3 4
The definition of non–PCI-related MI varied among the trials. In
particular, the criteria applied in PURSUIT were more sensitive,
resulting in a relatively high event rate.3 In the
present analysis, similar infarct definitions were applied
to all 3 trials (see Figure caption). Supplementary
analyses (not presented) demonstrated that the early
beneficial effects were consistent for different definitions of
MI.
In contrast to CAPTURE, the PURSUIT and PRISM-PLUS studies showed a slightly higher event rate among patients randomized to GP IIb/IIIa inhibition in the period starting 48 hours after PCI. This might be a result of differences in pharmacodynamics between the agents and between the degree, duration, and specificity of the GP IIb/IIIa inhibition, although there is no statistical evidence of a differential late treatment effect between the trials (and thus between the agents). Additional investigations are needed to clarify this issue.
In all 3 trials, bleeding complications were more common in patients treated with GP IIb/IIIa inhibitors than with placebo.3 4 6 In most cases, however, bleeding was mild and occurred at the arterial puncture site. The EPILOG trial has shown that the benefit of GP IIb/IIIa inhibition can be uncoupled from the risk of hemorrhage in PCI patients by low-dose, weight-adjusted heparin, adherence to stricter anticoagulation guidelines, and careful vascular access-site management.7
We conclude that enhanced platelet inhibition with a GP IIb/IIIa blocker in addition to aspirin and heparin, starting immediately after admission, is beneficial to patients with acute coronary syndromes without persistent ST-segment elevation. In addition, in those undergoing PCI, intensive platelet inhibition protects against myocardial damage associated with the intervention. Thus, to fully explore their beneficial effects, GP IIb/IIIa inhibitors should be initiated early after hospital admission and continued until after the procedure in patients undergoing PCI.
Received July 6, 1999; revision received September 2, 1999; accepted September 16, 1999.
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S.R Mehta, J.W Eikelboom, H.-J Rupprecht, B.S Lewis, M.K Natarajan, C Yi, J Pogue, and S Yusuf Efficacy of hirudin in reducing cardiovascular events in patients with acute coronary syndrome undergoing early percutaneous coronary intervention Eur. Heart J., January 2, 2002; 23(2): 117 - 123. [Abstract] [Full Text] [PDF]
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K.M. Akkerhuis, P.A.J. Klootwijk, W. Lindeboom, V.A.W.M. Umans, S. Meij, P.-P. Kint, and M.L. Simoons Recurrent ischaemia during continuous multilead ST-segment monitoring identifies patients with acute coronary syndromes at high risk of adverse cardiac events; meta-analysis of three studies involving 995 patients Eur. Heart J., November 1, 2001; 22(21): 1997 - 2006. [Abstract] [PDF]
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E. T.H. Yeh, H. V. Anderson, V. Pasceri, and J. T. Willerson C-Reactive Protein: Linking Inflammation to Cardiovascular Complications Circulation, August 28, 2001; 104(9): 974 - 975. [Full Text] [PDF]
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J.S. Alpert, A.J. Budaj, E.P. Gurfinkel, and T.D. Henry Issues in antithrombin therapy for UA/NSTEMI Eur. Heart J. Suppl., August 1, 2001; 3(suppl_J): J15 - J23. [Abstract] [PDF]
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K. Chatterjee, J. Col, A.J. Dalby, and D. Gulba Issues in antiplatelet therapy for UA/NSTEMI Eur. Heart J. Suppl., August 1, 2001; 3(suppl_J): J24 - J31. [Abstract] [PDF]
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C. P. Cannon, W. S. Weintraub, L. A. Demopoulos, R. Vicari, M. J. Frey, N. Lakkis, F.-J. Neumann, D. H. Robertson, P. T. DeLucca, P. M. DiBattiste, et al. Comparison of Early Invasive and Conservative Strategies in Patients with Unstable Coronary Syndromes Treated with the Glycoprotein IIb/IIIa Inhibitor Tirofiban N. Engl. J. Med., June 21, 2001; 344(25): 1879 - 1887. [Abstract] [Full Text] [PDF]
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M. I. Furman, H. L. Dauerman, R. J. Goldberg, J. Yarzbeski, D. Lessard, and J. M. Gore Twenty-two year (1975 to 1997) trends in the incidence, in-hospital and long-term case fatality rates from initial q-wave and non-q-wave myocardial infarction: a multi-hospital, community-wide perspective J. Am. Coll. Cardiol., May 1, 2001; 37(6): 1571 - 1580. [Abstract] [Full Text] [PDF]
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C. J KNIGHT National Institute for Clinical Excellence guidance: too NICE to glycoprotein IIb/IIIa inhibitors? Heart, May 1, 2001; 85(5): 481 - 483. [Full Text]
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G. N. Levine, M. N. Ali, and A. I. Schafer Antithrombotic Therapy in Patients With Acute Coronary Syndromes Arch Intern Med, April 9, 2001; 161(7): 937 - 948. [Abstract] [Full Text] [PDF]
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British Cardiac Society Guidelines and Medical Pra and Royal College of Physicians Clinical Effectiveness Guideline for the management of patients with acute coronary syndromes without persistent ECG ST segment elevation Heart, February 1, 2001; 85(2): 133 - 142. [Full Text]
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J. A. Cairns, P. Theroux, H. D. Lewis Jr., M. Ezekowitz, and T. W. Meade Antithrombotic Agents in Coronary Artery Disease Chest, January 1, 2001; 119 (2009): 228S - 252S. [Full Text] [PDF]
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A. Manhapra and S. Borzak Regular review: Treatment possibilities for unstable angina BMJ, November 18, 2000; 321(7271): 1269 - 1275. [Full Text]
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R. J. de Winter Risk stratification with cardiac troponin I in acute coronary syndromes J. Am. Coll. Cardiol., November 15, 2000; 36(6): 1824 - 1826. [Full Text] [PDF]
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D. L. Bhatt and E. J. Topol Current Role of Platelet Glycoprotein IIb/IIIa Inhibitors in Acute Coronary Syndromes JAMA, September 27, 2000; 284(12): 1549 - 1558. [Abstract] [Full Text] [PDF]
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E. Braunwald, E. M. Antman, J. W. Beasley, R. M. Califf, M. D. Cheitlin, J. S. Hochman, R. H. Jones, D. Kereiakes, J. Kupersmith, T. N. Levin, et al. ACC/AHA guidelines for the management of patients with unstable angina and non-st-segment elevation myocardial infarction: A report of the american college of cardiology/ american heart association task force on practice guidelines (committee on the management of patients with unstable angina) J. Am. Coll. Cardiol., September 1, 2000; 36(3): 970 - 1062. [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: acute coronary syndromes without persistent ST segment elevation. Recommendations of the Task Force of the European Society of Cardiology: Recommendations of the Task Force of the European Society of Cardiology Eur. Heart J., September 1, 2000; 21(17): 1406 - 1432. [PDF]
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S.J. Brener and E.J. Topol Troponin, embolization and restoration of microvascular integrity Eur. Heart J., July 2, 2000; 21(14): 1117 - 1119. [PDF]
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E. Boersma, K. S. Pieper, E. W. Steyerberg, R. G. Wilcox, W.-C. Chang, K. L. Lee, K. M. Akkerhuis, R. A. Harrington, J. W. Deckers, P. W. Armstrong, et al. Predictors of Outcome in Patients With Acute Coronary Syndromes Without Persistent ST-Segment Elevation : Results From an International Trial of 9461 Patients Circulation, June 6, 2000; 101(22): 2557 - 2567. [Abstract] [Full Text] [PDF]
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