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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.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention
Keywords: Cost-Benefit Analysis, Platelet Aggregation Inhibitors, Troponin T, Coronary Disease, Ticlopidine, Immunoglobulin Fab Fragments, Thrombocytopenia, Percutaneous Coronary Intervention
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