A randomised trial comparing same-day discharge with overnight hospital stay after elective percutaneous coronary intervention (PCI): the Elective Percutaneous coronary intervention in Outpatient Study

ISRCTN ISRCTN75891755
DOI https://doi.org/10.1186/ISRCTN75891755
Secondary identifying numbers N/A
Submission date
24/10/2005
Registration date
25/10/2005
Last edited
29/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G.S. Heyde
Scientific

Academic Medical Centre
Meibergdreef 15
Department of Cardiology
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)20 5669111
Email g.s.heyde@amc.uva.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymEPOS
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAngina pectoris
InterventionAfter 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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date01/07/2000
Completion date21/03/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants800
Key inclusion criteriaPatients scheduled to undergo elective percutaneous coronary intervention in the Academic Medical Centre in Amsterdam who remain at home prior to the procedure
Key exclusion criteria1. 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
Date of first enrolment01/07/2000
Date of final enrolment21/03/2003

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Center, Amsterdam (Netherlands)
Hospital/treatment centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Funders

Funder type

Other

Dutch Health Care Insurance Board (CVZ, independent government organisation)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2007 Yes No