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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
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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