Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      This is a multi-center trial that will evaluate the safety, feasibility, and cost
      effectiveness of discharging patients, who have had successful percutaneous coronary
      intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24
      hours after the procedure. Patients will be randomized in a 3 (test): 1 (control) fashion and
      will have a study population of 600 patients over 6 investigational sites all within the
      United States. Patients <65 years old will be chosen in order to stay within the low risk
      group and will be followed up after 24 hours, 7 days, and 30 days via phone or office visit.
      The primary endpoint will be a composite of major adverse cardiac and cerebral events, and
      the incidence of major bleeding or vascular complications. Data acquired from the study, such
      as blinded financial information and patient satisfaction surveys, will be used in order to
      evaluate cost analysis and safety of the procedure.
    

Detailed description: 
      Closure devices are a relatively new method for sealing the femoral arterial puncture
      following procedures including percutaneous intervention (PCI). Because the risk of severe
      complications (e.g., bleeding, myocardial infarction, stroke, and mortality) associated with
      PCI when closure devices are very low, many patients undergoing PCI may be considered
      eligible for a same day hospital discharge. As the practice of ambulatory PCI is becoming
      more common, it is important to evaluate the readiness of patients under-going PCI for
      same-day discharge and anxiety and coping abilities of patients post-discharge. Our
      hypothesis is that same day discharge of patients who have undergone a PCI procedure with
      closure using a vascular closure device is safe, patients will be comfortable with a same day
      discharge and this process will be more cost efficient than the current standard of staying
      in the hospital overnight. The current pilot study is a multi-center, randomized parallel
      arm, controlled trial of low-risk patients undergoing an elective PCI procedure. Overall, 600
      patients will be enrolled. After providing informed consent, participants will be randomized
      to leave the hospital on the same day as the PCI procedure or stay overnight in a 1:1 ratio.
      Data collection includes a self-administered questionnaire at hospital discharge, telephone
      interviews at 7-days and 30-days post-hospital discharge, and chart abstraction. The primary
      outcome for this study is differences across randomization arm in patient satisfaction scores
      on the validated 10-item Post-discharge coping difficulty scale assessed 7 days
      post-discharge. Secondary outcomes will include differences across randomization group for
      symptoms of anxiety, readiness for hospital discharge, patient satisfaction with the timing
      of their discharge, post-procedure pain and soreness, and cost-savings. While a data safety
      monitoring board will track all adverse events (i.e., myocardial infarction, hematoma,
      hospitalizations, and mortality), we anticipate too few events to occur to make meaningful
      inferences beyond that PCI is safe regardless of the timing of hospital discharge. The data
      from this pilot study will determine the comfort patients experience after undergoing PCI
      with an ambulatory (i.e, same-day) hospital discharge. Furthermore, this pilot study will
      provide the foundation for a large scale non-inferiority study of same-day discharge on
      outcomes including myocardial infarction, bleeding, and mortality. Such data will indicate
      the overall feasibility of early ambulatory PCI and has the potential to radically alter
      health care delivery following PCI.
    

Intervention name(s): discharge vs. overnight stay
Intervention type(s): Other
Intervention description(s): At six hours post-PCI,patients will be randomized to be discharged immediately or to stay overnight in the hospital for observation and discharged the following day. Randomization will occur in a 1:1 ratio. Additionally, randomization will be performed stratified by study site.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The target population for this study will include patients undergoing an elective PCI.
        Overall, 600 patient will be recurited from two sites in the United Sates. As this is a
        feasiblity study, enrollment will be restricted to low-risk patients. For this reason, the
        study will be limited to patients under 75 years of age. All patients must meet all of the
        inclusion criteria and have none of the exclusion criteria to be enrolled into the study.
      
Keywords: Percutaneous Intervention; Percutaneous Coronary Intervention; Catheterization; Coronary Catheterization; Same day Discharge; Next Day Discharge; Patient Satisfaction; Multi-Center; Randomized; Low-risk PCI; BlindedClosure device; Vascular closure device