From the Cleveland Clinic Foundation, Cleveland, Ohio (S.J.B., D.J.M.,
E.J.T.); Midwest Heart Research, Lombard, Ill (L.A.B.); University of
Pittsburgh Medical Center, Pittsburgh, Pa (J.E.B.B.); North Shore University
Hospital, Manhasset, NY (S.K.); Riverside Methodist Hospital, Columbus, Ohio
(B.S.G.); Crozer Chester Medical Center, Upland, Pa (A.A.J.); Baptist Medical
Center, Birmingham, Ala (E.D.C.); St Joseph Hospital, Savannah, Ga (P.C.G.);
Presbyterian Health Care Center, Albuquerque, NM (H.J.W.); High Point Regional
Hospital, High Point, NC (H.B.C.); Lenox Hill Hospital, New York, NY (J.W.M.);
and Lilly Research Laboratories, Indianapolis, Ind (M.B.E.).
Correspondence to Eric J. Topol, MD, Department of Cardiology, 9500 Euclid Ave, Cleveland Clinic Foundation, Cleveland, OH 44195. E-mail topole{at}cesmtp.ccf.org
Background—The benefit of
catheter-based reperfusion for acute myocardial infarction (MI) is
limited by a 5% to 15% incidence of in-hospital major
ischemic events, usually caused by infarct artery reocclusion,
and a 20% to 40% need for repeat percutaneous or
surgical revascularization. Platelets play a
key role in the process of early infarct artery reocclusion, but
inhibition of aggregation via the glycoprotein IIb/IIIa
receptor has not been prospectively evaluated in the setting of
acute MI.
Methods and Results—Patients with acute MI of <12 hours'
duration were randomized, on a double-blind basis, to placebo or
abciximab if they were deemed candidates for primary PTCA. The primary
efficacy end point was death, reinfarction, or any (urgent or elective)
target vessel revascularization (TVR) at 6 months
by intention-to-treat (ITT) analysis. Other key prespecified
end points were early (7 and 30 days) death, reinfarction, or urgent
TVR. The baseline clinical and angiographic variables of the 483
(242 placebo and 241 abciximab) patients were balanced. There was no
difference in the incidence of the primary 6-month end point (ITT
analysis) in the 2 groups (28.1% and 28.2%,
P=0.97, of the placebo and abciximab patients,
respectively). However, abciximab significantly reduced the incidence
of death, reinfarction, or urgent TVR at all time points assessed
(9.9% versus 3.3%, P=0.003, at 7 days; 11.2% versus
5.8%, P=0.03, at 30 days; and 17.8% versus 11.6%,
P=0.05, at 6 months). Analysis by actual
treatment with PTCA and study drug demonstrated a considerable effect
of abciximab with respect to death or reinfarction: 4.7% versus 1.4%,
P=0.047, at 7 days; 5.8% versus 3.2%,
P=0.20, at 30 days; and 12.0% versus 6.9%,
P=0.07, at 6 months. The need for unplanned,
"bail-out" stenting was reduced by 42% in the abciximab group
(20.4% versus 11.9%, P=0.008). Major bleeding occurred
significantly more frequently in the abciximab group (16.6% versus
9.5%, P=0.02), mostly at the arterial
access site. There was no intracranial hemorrhage in either
group.
Conclusions—Aggressive platelet inhibition with abciximab
during primary PTCA for acute MI yielded a substantial reduction in the
acute (30-day) phase for death, reinfarction, and urgent target vessel
revascularization. However, the bleeding rates were
excessive, and the 6-month primary end point, which included elective
revascularization, was not favorably affected.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
Randomized, Placebo-Controlled Trial of Platelet Glycoprotein IIb/IIIa Blockade With Primary Angioplasty for Acute Myocardial Infarction
Key Words: angioplasty • myocardial infarction • platelet aggregation inhibitors
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