Circulation, Vol 90, 1757-1764, Copyright © 1994 by American Heart Association
JE Tcheng, SG Ellis, BS George, DJ Kereiakes, NS Kleiman, JD Talley, AL Wang, HF Weisman, RM Califf and EJ Topol
BACKGROUND: Thrombosis has been implicated as central to the clinical
complications of coronary angioplasty (PTCA). Chimeric monoclonal 7E3 Fab
(c7E3 Fab) is the first of a new class of antiplatelet drugs directed at
the platelet glycoprotein IIb/IIIa integrin. This study was performed to
determine the pharmacodynamics of c7E3 Fab administration during PTCA and
to gain an initial clinical experience with this novel agent. METHODS AND
RESULTS: The study was a multicenter, open-label, dose-escalation study
conducted in two stages. Enrollment included 56 patients scheduled for
elective PTCA who were estimated to be at moderate to high risk of
sustaining ischemic complications. All patients were given aspirin and
heparin. The study drug was given at least 10 minutes before PTCA. In stage
1, increasing bolus doses of c7E3 Fab were given to 15 patients; a bolus
dose of 0.25 mg/kg was found to result in blockade of > 80% of the
receptors and reduce platelet aggregation to < 20% compared with
baseline, establishing this dose as that necessary to sufficiently suppress
platelet activity. In stage 2, additional c7E3 Fab was administered by
continuous infusion to 32 patients for progressively longer periods of time
(up to 24 hours) to confirm that platelet inhibition could be maintained
with prolonged drug infusion. Also, 9 patients otherwise meeting entry
criteria were given placebo. There were no thrombotic events among patients
receiving c7E3 Fab. Overall procedural and clinical success and
complication rates as well as rates of bleeding were statistically similar
among groups. However, minor bleeding was more frequent with administration
of the active drug. CONCLUSIONS: The novel antiplatelet agent c7E3 Fab can
be administered during PTCA in combination with aspirin and heparin.
Suppression of platelet activity is dose dependent and can be maintained
for up to 24 hours. Further evaluation will be required to determine the
extent of improvement in ischemic complication and restenosis rates and to
provide additional insight into the safety profile of this potent
monoclonal platelet antibody.
ARTICLES
Pharmacodynamics of chimeric glycoprotein IIb/IIIa integrin antiplatelet antibody Fab 7E3 in high-risk coronary angioplasty
Department of Medicine, Duke University Medical Center, Durham, NC 27710.
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