One-year clinical outcome after abciximab bolus-only compared with abciximab bolus and 12-hour infusion in the Randomized EArly Discharge after Transradial Stenting of CoronarY Arteries (EASY) Study.
BACKGROUND
Long-term clinical follow-up has shown a significant benefit after percutaneous coronary intervention (PCI) for abciximab bolus followed by 12-hour infusion over placebo or bolus-only. With contemporary techniques and clopidogrel pretreatment, it is unknown whether the 12-hour infusion is still associated with a clinical benefit. The purpose of this study is to compare 6- and 12-month clinical outcomes in patients treated after PCI with abciximab bolus-only and abciximab bolus followed by 12-hour infusion.


METHODS
After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day discharge and no infusion of abciximab (bolus-only group, n = 504) or to overnight hospitalization and 12 hours (0.125 microg/[kg min]) of abciximab infusion (bolus + infusion group, n = 501). The rate of major adverse cardiovascular events (MACE) was evaluated at 30 days, 6 months, and 12 months.


RESULTS
At 30 days, the rate of MACE including death, myocardial infarction, and target vessel revascularization was similar in the 2 groups: 1.4% in the bolus-only group versus 1.8% in the bolus + infusion group (P = .63). At 6 months, the MACE rate was 5.6% in the 2 randomized groups. At 12 months, the MACE rate was also similar in both groups: 8.7% in the bolus-only group and 9.2% in the bolus + infusion group (hazard ratio 0.97, 95% CI 0.79-1.20, P = .80). Similar efficacy was also observed in several subgroups including higher-risk patients such as those with elevated troponin T before PCI.


CONCLUSIONS
In patients pretreated with clopidogrel and undergoing uncomplicated coronary artery stenting, there is no difference in the 6- and 12-month outcomes between patients treated with abciximab bolus-only versus those treated with bolus + infusion, a finding consistent with the initial 30-day outcomes.
Bertrand
Olivier F
OF
Hôpital Laval, Institut Universitaire de Cardiologie et de Pneumologie, Quebec, Canada. olivier.bertrand@crhl.ulaval.ca
Rodés-Cabau
Josep
J
Larose
Eric
E
Nguyen
Can Manh
CM
Roy
Louis
L
Déry
Jean-Pierre
JP
Courtis
Javier
J
Nault
Isabelle
I
Poirier
Paul
P
Costerousse
Olivier
O
De Larochellière
Robert
R
D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010351:Patient Discharge / Q000639:trends*; D020551:Pulse Therapy, Drug; D017534:Radial Artery; D012016:Reference Values; D018570:Risk Assessment; D015607:Stents; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D000077284:Abciximab