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
Completed
- Conditions
- Angina pectorisCirculatory System
- Registration Number
- ISRCTN75891755
- Lead Sponsor
- Academic Medical Center, Amsterdam (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 800
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 1. Indication for extended observation<br>2. The occurrence of major adverse cardiac events and puncture site complications from randomization until 30 days after PCI<br>3. Quality of life scores before and after PCI<br>4. Actual costs related to PCI, aftercare and 30 days follow-up