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Elective PCI in Outpatient Study - EPOS
Description:
The goal of the trial was to evaluate a strategy of same-day discharge compared with an overnight hospital stay among patients undergoing elective percutaneous coronary intervention (PCI) via a femoral approach.
Hypothesis:
Elective PCI in a same-day discharge setting would not lead to more cardiac or puncture-related complications than elective PCI in an overnight-stay setting.
Study Design
Study Design:
Patients Screened: 4,602
Patients Enrolled: 800
Mean Follow Up: One year
Mean Patient Age: Mean age, 62 years
Female: 19
Patient Populations:
Scheduled elective PCI and staying at home before the procedure
Exclusions:
Acute coronary syndrome, diagnostic catheterization with possible ad hoc PCI, scheduled use of guiding catheters >6 French in diameter, elective use of glycoprotein IIb/IIIa receptor blockers, long-term systemic anticoagulation, home >60 minutes away from the intervention center, or patients with expected difficult follow-up
Primary Endpoints:
Composite of cardiac death, MI, stroke, coronary artery bypass grafting, repeat PCI, or severe complications of the arterial puncture with the need for blood transfusion or repeat compression until 24 hours after PCI, evaluated for noninferiority
Secondary Endpoints:
Indication for extended observation, the occurrence of major adverse cardiac events, and puncture site complications from randomization until 30 days after PCI
Drug/Procedures Used:
Patients were randomized to intended discharge on the same day as the PCI (n = 403) or to intended overnight hospitalization (n = 397). Four hours after the PCI, patients were categorized as suitable for early discharge or not. If suitable for early discharge, the randomization scheme was carried out (discharged immediately or kept overnight). If not suitable for early discharge, patients were kept overnight regardless of randomization strategy. PCIs were performed via a femoral approach.
Principal Findings:
Stents were used in 72% of cases. Multivessel intervention was performed in 41% of patients. Lesion location was in the left anterior descending artery in 40% of cases. Indication for extended stay was required in 19% of the same-day discharge group and 21% of the overnight stay group. Among patients randomized to same-day discharge, 77% were actually discharged on the same day.
The composite primary endpoint occurred in 2.2% of the same-day discharge group and in 4.2% of the overnight-stay group within 24 hours of PCI (risk difference -0.020, p < 0.0001 for noninferiority). Among the cohort deemed suitable for early discharge, the composite endpoint occurred in 0.3% of the same-day discharge group and 0.6% of the overnight-stay group. Hematoma >5 cm was present in 5.0% of the same-day discharge group and 4.5% of the overnight-stay group.
Costs were lower by a mean of 258 Euros per patient in the same-day discharge group. Clinical events were similar at 1 year, with major adverse cardiac or cerebral events occurring in 16.6% of the same-day discharge group and 16.4% of the overnight-stay group, the majority of which were target vessel revascularizations.
Interpretation:
Among patients undergoing elective PCI via a femoral approach, a strategy of same-day discharge was associated with a similar composite clinical event rate compared with a strategy of overnight hospitalization, meeting the criteria for noninferiority.
Results of the present study were similar to those of the EASY trial, which showed noninferiority for clinical events for same-day discharge compared with overnight stay following PCI when using a radial approach. Additionally, patients in the overnight-stay group in EASY received abciximab bolus plus infusion while those in the same day discharge group received only an abciximab bolus.
As with EASY, patients in the trial were low risk, as evidenced by the low event rate; all patients in the present study underwent elective PCI. These two trials show that same-day discharge is feasible among very low-risk patients undergoing PCI; data cannot be extrapolated to higher risk patients.
References:
Heyde GS, Koch KT, de Winter RJ, et al. Randomized trial comparing same-day discharge with overnight hospital stay after percutaneous coronary intervention: results of the Elective PCI in Outpatient Study (EPOS). Circulation 2007;115:2299-306.
Keywords: Punctures, Coronary Disease, Hematoma, Immunoglobulin Fab Fragments, Angioplasty, Balloon, Coronary, Stents, Percutaneous Coronary Intervention, Length of Stay
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