Safety and efficacy of the platelet glycoprotein IIb/IIIa inhibitor abciximab in Chinese patients undergoing high-risk angioplasty.
BACKGROUND
Platelets are believed to play a role in the ischemic complications of coronary angioplasty, such as abrupt closure of coronary vessels during or soon after the procedure. Accordingly, we evaluated the effect of a chimeric monoclonal antibody abciximab, directed against the platelet glycoprotein IIb/IIIa receptor, in patients undergoing angioplasty who were at high risk for ischemic complications. This receptor is the final common pathway for platelet aggregation.


METHODS
In a prospective, double-blind trial, we randomly assigned 42 patients to receive a bolus and an infusion of placebo or a bolus and an infusion of abciximab. Low-dose, weight-adjusted heparin (initial dose of 70 U/kg of body weight) was used in both groups. Patients underwent coronary angioplasty for high-risk clinical situations involving unstable angina or high-risk coronary morphologic characteristics. The primary study end-point consisted of any of the following: death, nonfatal myocardial infarction, unplanned surgical revascularization, unplanned repeat percutaneous procedure, unplanned implantation of a coronary stent, or insertion of an intra-aortic balloon pump for refractory ischemia within 30 days of randomization.


RESULTS
Compared with placebo, the abciximab resulted in a trend toward reduction in periprocedural myocardial infarction from 15% to 0%, although the differences were not statistically significant (p = 0.099). There were no significant differences between the two groups in the risk of major and minor bleeding and the need for blood transfusion.


CONCLUSIONS
Inhibition of platelet glycoprotein IIb/IIIa receptor with abciximab, together with low-dose, weight-adjusted heparin, had a favorable trend toward the reduction of periprocedural myocardial infarction in patients undergoing high-risk angioplasty, without increasing the risk of hemorrhage.
Chen
Y H
YH
Department of Medicine, Taipei Veterans General Hospital, Taiwan, ROC.
Chen
J W
JW
Wu
T C
TC
Ding
P Y
PY
Wang
S P
SP
Chang
M S
MS
D000077284:Abciximab; D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001777:Blood Coagulation; D003327:Coronary Disease / Q000097:blood / Q000628:therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077284:Abciximab