One year outcomes with abciximab vs. placebo during percutaneous coronary intervention after pre-treatment with clopidogrel.
OBJECTIVE
In the Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Trial, the use of abciximab in patients undergoing percutaneous coronary intervention (PCI) after pretreatment with 600 mg clopidogrel for >2 h was associated with no clinically measurable benefit at 30 days. We assessed whether there was any clinical benefit from abciximab at 1 year follow-up.


RESULTS
After pre-treatment with 600 mg clopidogrel, a total of 2159 patients undergoing PCI for stable or unstable angina without marked ST-segment shifts or positive biomarkers were randomly assigned to receive abciximab or placebo. The occurrence of the composite endpoint of death, myocardial infarction, or target vessel revascularization was assessed at 1 year after randomization. At 1 year, the composite endpoint occurred in 23.8% of the patients in each group [relative risk (RR), 1.01; 95% confidence interval (CI), 0.85-1.20; P=0.92]. The combined incidence of death and myocardial infarction was 6.0% in the abciximab group and 6.4% in the placebo group (RR, 0.94; 95% CI, 0.67-1.32; P=0.73). The mortality rate was 2.1% in the abciximab group and 2.4% in the placebo group (RR, 0.88; 95% CI, 0.50-1.54; P=0.66). No trend towards clinical benefit was observed with abciximab at 1 year in any subgroup analysed.


CONCLUSIONS
In patients with a low-to-intermediate risk profile undergoing PCI after pre-treatment with a 600 mg clopidogrel for at least 2 h, the use of abciximab offers no additional clinical benefit at 1 year.
Schömig
Albert
A
Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany. aschoemig@dhm.mhn.de
Schmitt
Claus
C
Dibra
Alban
A
Mehilli
Julinda
J
Volmer
Christian
C
Schühlen
Helmut
H
Dirschinger
Josef
J
Dotzer
Franz
F
ten Berg
Jurriën M
JM
Neumann
Franz-Josef
FJ
Berger
Peter B
PB
Kastrati
Adnan
A
D000077284:Abciximab; D000368:Aged; D000789:Angina, Unstable / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000925:Anticoagulants / Q000008:administration & dosage*; D000077144:Clopidogrel; D016757:Death, Sudden, Cardiac / Q000209:etiology; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D009204:Myocardial Revascularization; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D012307:Risk Factors; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D000077284:Abciximab