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Early Discharge After Transradial Stenting of Coronary Arteries - EASY
Description:
The goal of the EASY study was to evaluate a strategy of a single bolus of abciximab followed by same day discharge compared with a bolus of abciximab plus infusion followed by an overnight hospital stay among patients undergoing percutaneous coronary intervention (PCI) via a transradial approach.
Hypothesis:
Treatment with a single bolus of abciximab followed by same day discharge will be non-inferior to a bolus of abciximab plus infusion followed by an overnight hospital stay among patients undergoing PCI via a transradial approach.
Study Design
Study Design:
Patients Screened: 3277
Patients Enrolled: 1005
Mean Follow Up: 30 days
Mean Patient Age: Mean age 60 years
Female: 22
Patient Populations:
Age >18 years, documented ischemic heart disease, and referred for angiography with or without PCI.
Exclusions:
ST elevation myocardial infarction within 72 hours, LVEF ≤30%, contraindication to abciximab
Primary Endpoints:
Composite of death, MI, urgent revascularization, re-hospitalization, severe thrombocytopenia, access site complications, or major bleed at 30 days
Secondary Endpoints:
Composite of death, MI, target vessel revascularization at 30 days.
Drug/Procedures Used:
All patients received a bolus of abciximab prior to angiography. Following PCI via a transradial approach with optimal results, patients at a single center were randomized to no additional abciximab with a same day discharge (n=504) or an additional abciximab infusion followed by an overnight hospital stay (n=501). Patients who received the bolus of abciximab prior to angiography but were not randomized were included in a parallel registry (n=343).
Principal Findings:
Baseline characteristics were similar in the two treatment groups, with non-ST elevation MI present in 18% of the single bolus abciximab group and 19% of the bolus plus infusion group. Clopidogrel treatment for >12 hours was used in 91% of patients. Two-vessel disease was present in 29% of patients. Among patients in the single bolus with early discharge strategy, 88% went home on the same day as PCI.
The primary composite endpoint of death, MI, urgent revascularization, re-hospitalization, severe thrombocytopenia, access site complications, or major bleed at 30 days did not differ between treatment groups (using troponin-T definition of MI: 20.4% for single abciximab bolus group vs 18.2% for bolus plus infusion group, p=0.017 for noninferiority; using CKMB definition of MI: 11.1% for single abciximab bolus group vs 9.6% for bolus plus infusion group, p=0.0004 for noninferiority). There was no difference in any component of the primary endpoint. Major bleeding occurred in 0.8% of the single abciximab bolus group vs 0.2% for bolus plus infusion group.
Interpretation:
Among patients undergoing PCI via a transradial approach, use of a single bolus of abciximab followed by same day discharge was non-inferior for the primary composite endpoint at 30 days compared to use of a single bolus plus infusion of abciximab followed by overnight hospitalization.
Use of a single bolus of abciximab followed by early discharge home may lower treatment-related costs. However, a formal cost effectiveness study was not undertaken. Additionally, the population in the trial was low-risk as evidenced by the low 30 day death, MI and revascularization rate. Use of such a strategy in higher-risk patients may not have similar results.
References:
Bertrand OF, et al. A Randomized Study Comparing Same-Day Home Discharge and Abciximab Bolus Only to Overnight Hospitalization and Abciximab Bolus and Infusion After Transradial Coronary Stent Implantation. Circulation. 2006;114:2636-2643.
Presented by Dr. Olivier F. Bertrand at the American Heart Association Scientific Session, Dallas, Texas, November 2005.
Presented by Dr. Bertrand at the EuroPCR meeting, Paris, France, May 2005.
Keywords: Cost-Benefit Analysis, Platelet Aggregation Inhibitors, Troponin T, Coronary Disease, Ticlopidine, Immunoglobulin Fab Fragments, Thrombocytopenia, Percutaneous Coronary Intervention
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