Correspondence to David J. Moliterno, MD, Department of Cardiology, F-25, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195. E-mail molited{at}cesmtp.ccf.org
Background—Unstable angina and
non–Q-wave myocardial infarction involve coronary
arterial plaque rupture, platelet activation, and
thrombus formation. This study tested the benefit of different doses of
lamifiban (a platelet IIb/IIIa antagonist) alone and in
combination with heparin in patients with these conditions to select
the most promising lamifiban regimen for subsequent
evaluation.
Methods and Results—At 273 hospitals in 20 countries, 2282
patients were randomly assigned to lamifiban (2x2 factorial design:
low-dose [1 µg/min] with and without heparin versus high-dose [5
µg/min] with and without heparin) or to standard therapy (placebo
and heparin). All patients received aspirin. The composite primary end
point of death or nonfatal myocardial infarction at 30 days occurred in
11.7% of those receiving standard therapy, 10.6% receiving low-dose
lamifiban, and 12.0% receiving high-dose lamifiban
(P=0.668). By 6 months, this composite was lowest for
those assigned to low-dose lamifiban (P=0.027) and
intermediate for those assigned to high-dose lamifiban
(P=0.450) compared with control (13.7%, 16.4%, and
17.9%, respectively). Compared with control, the combination of
high-dose lamifiban and heparin resulted in more intermediate or major
bleeding (12.1% versus 5.5%; P=0.002) and a similar
rate of ischemic events. Conversely, low-dose lamifiban and
heparin yielded similar bleeding rates as in the control group but
fewer ischemic events at 6 months (12.6% versus 17.9%;
P=0.025).
Conclusions—In unstable angina and non–Q-wave infarction,
platelet IIb/IIIa antagonism with lamifiban reduces adverse
ischemic events at 6 months beyond that of aspirin and heparin
therapy. The role of conjunctive heparin remains uncertain but appears
more favorable with low-dose IIb/IIIa antagonism. Larger-scale study is
needed to more reliably estimate these effects.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
International, Randomized, Controlled Trial of Lamifiban (a Platelet Glycoprotein IIb/IIIa Inhibitor), Heparin, or Both in Unstable Angina
Key Words: angina • myocardial infarction • platelet aggregation inhibitors • heparin
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