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
Protocol serial number	N/A
Sponsor	Academic Medical Center, Amsterdam (Netherlands)
Funder	Dutch Health Care Insurance Board (CVZ, independent government organisation)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EPOS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	21/03/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	800
Key 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
Key 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
Date of first enrolment	01/07/2000
Date of final enrolment	21/03/2003

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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