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
Scientific
Academic Medical Centre
Meibergdreef 15
Department of Cardiology
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5669111 |
|---|---|
| g.s.heyde@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/07/2000 |
| Completion date | 21/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
1105 AZ
Netherlands
Sponsor information
Academic Medical Center, Amsterdam (Netherlands)
Hospital/treatment centre
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
