Long-term treatment with a platelet glycoprotein-receptor antagonist after percutaneous coronary revascularization. EXCITE Trial Investigators. Evaluation of Oral Xemilofiban in Controlling Thrombotic Events.
BACKGROUND
When administered intravenously at the time of percutaneous coronary revascularization, glycoprotein IIb/IIIa receptor antagonists decrease the incidence of death and nonfatal myocardial infarction and the need for urgent revascularization. We hypothesized that long-term administration of oral glycoprotein IIb/IIIa antagonists, which block the aggregation of platelets, might stabilize intravascular plaque and prevent additional ischemic cardiac events.


METHODS
We conducted a prospective, double-blind trial in which 7232 patients were randomly assigned to receive 20 mg of oral xemilofiban or placebo 30 to 90 minutes before undergoing percutaneous coronary revascularization, with maintenance doses of 10 or 20 mg of xemilofiban or placebo administered three times daily for up to 182 days. There were two primary composite end points: one was death, nonfatal myocardial infarction, or urgent revascularization at 182 days, and the other was death or nonfatal myocardial infarction at 182 days.


RESULTS
Death, myocardial infarction, or urgent revascularization occurred within 182 days in 324 patients who received placebo (Kaplan-Meier cumulative event rate, 13.5 percent), 332 who received 10 mg of xemilofiban (13.9 percent, P=0.82 for the comparison with placebo), and 306 who received 20 mg of xemilofiban (12.7 percent, P=0.36 for the comparison with placebo). The incidence of death or myocardial infarction was also similar in all three groups. Clinically significant hemorrhagic complications and thrombocytopenia were infrequent.


CONCLUSIONS
The administration of the glycoprotein IIb/IIIa antagonist xemilofiban before percutaneous coronary revascularization and for up to six months thereafter does not significantly reduce the incidence of important clinical end points.
O'Neill
W W
WW
Division of Cardiology, William Beaumont Hospital, Royal Oak, Mich 48073, USA. woneill@beaumont.edu
Serruys
P
P
Knudtson
M
M
van Es
G A
GA
Timmis
G C
GC
van der Zwaan
C
C
Kleiman
J
J
Gong
J
J
Roecker
E B
EB
Dreiling
R
R
Alexander
J
J
Anders
R
R
D000284:Administration, Oral; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000706:statistics & numerical data; D001550:Benzamidines / Q000008:administration & dosage* / Q000009:adverse effects; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D015607:Stents; D013921:Thrombocytopenia / Q000139:chemically induced
D001550:Benzamidines; D010975:Platelet Aggregation Inhibitors; C091295:xemilofiban