Condition category
Circulatory System
Date applied
24/10/2005
Date assigned
25/10/2005
Last edited
29/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Academic Medical Center, Amsterdam (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes