Contact information
Type
Scientific
Primary contact
Dr G.S. Heyde
ORCID ID
Contact details
Academic Medical Centre
Meibergdreef 15
Department of Cardiology
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5669111
g.s.heyde@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
EPOS
Study hypothesis
The Elective PCI in Outpatient Study (EPOS) is designed to evaluate the safety and feasibility of discharge the same day as PCI, by testing the hypothesis that patients requiring extended observation can be selected effectively and that same-day discharge does not increase the complication rate as compared to overnight hospital stay.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Angina pectoris
Intervention
After percutaneous coronary intervention, patients are observed for 4 hours.
1. Patients randomized to same-day discharge are ambulated after this period and discharged.
2. Patients randomized to overnight stay are discharged the following day. Indications for extended hospital stay are based on pre-defined clinical and angiographic criteria.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The primary endpoint of the study is the composite of major adverse cardiac events and severe complications of the arterial puncture with the need of blood transfusion or repeat compression, from randomization until 24 hours after PCI.
Secondary outcome measures
1. Indication for extended observation
2. The occurrence of major adverse cardiac events and puncture site complications from randomization until 30 days after PCI
3. Quality of life scores before and after PCI
4. Actual costs related to PCI, aftercare and 30 days follow-up
Overall trial start date
01/07/2000
Overall trial end date
21/03/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Patients scheduled to undergo elective percutaneous coronary intervention in the Academic Medical Centre in Amsterdam who remain at home prior to the procedure
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
800
Participant exclusion criteria
1. Scheduled use of guiding catheters larger than 6 French (F) in diameter
2. Elective use of glycoprotein 2b/3a receptor blockers
3. Long-term systemic anti-coagulation
4. Residence of more than 60 minutes drive from an intervention center
5. No adult care person available at home for first 24 hours after PCI
6. Diagnostic coronary artery catheterization with possible ad hoc PCI
Recruitment start date
01/07/2000
Recruitment end date
21/03/2003
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
Funders
Funder type
Other
Funder name
Dutch Health Care Insurance Board (CVZ, independent government organisation)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17420341
Publication citations
-
Results
Heyde GS, Koch KT, de Winter RJ, Dijkgraaf MG, Klees MI, Dijksman LM, Piek JJ, Tijssen JG, 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, 17, 2299-2306, doi: 10.1161/CIRCULATIONAHA.105.591495.