Coronary Artery Disease
Conditions
Keywords
percutaneous coronary intervention
Brief summary
To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention, early discharge is safe and feasible.
Detailed description
A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel. During PCI, patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device. Patients that stay overnight in the hotel must be accompanied by a family member. They return to the cath lab the next day for groin check and blood work. Satisfaction questionnaires are filled out by all patients.
Interventions
PROCEDUREEarly discharge after percutaneous coronary intervenntion
Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.
Sponsors
Abbott Medical Devices
The Medicines Company
University of Pennsylvania
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention
Exclusion criteria
* Patients with acute coronary syndrome, patients with an MI within 30 days, an ejection fraction \<30%, those with history of IV Dye allergy, creatinine level\>2.2, those with increased risk of infection, those with history of bleeding diathesis or anemia (hemoglobin\<11.0 g/dl, platelets \<100,000 tho/ul)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are patient satisfaction and safety. | 30 days |
Outcome results
None listed