Same Day Discharge After Coronary Stenting Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      In comparison to delayed hospital discharge, a strategy of early hospital discharge of
      patients who undergo single and multivessel stenting for type A, B, and C lesion(s) using
      thienopyridine and a hemostatic femoral closure device, is associated with similar clinical
      outcomes, but greater patient satisfaction and similar cost.
    

Detailed description: 
      This study will be a single center prospective, randomized, non-inferiority study of
      four-hundred patients with stable and unstable angina (CCS class I-IV), type A, B, C
      lesion(s), single and multivessel disease undergoing single or multivessel coronary artery
      stenting. All patients will be screened and consented prior to the coronary artery stenting
      procedure. All patients will receive an oral bolus of a thienopyridine as pre-treatment or
      immediately after stent implantation. All patients will be anticoagulated with bilvalirudin
      or heparin during the procedure. Common femoral angiography will be performed at the end of
      the procedure via the side-arm of the sheath in the ipsilateral oblique view (20-40°). In
      patients with visible atherosclerotic disease or small common femoral arteries on angiography
      the size and/or the degree of stenosis will be measured by quantitative angiography.
      Hemostasis of the femoral-arteriotomy access site will be facilitated by deployment of a
      hemostatic closure device (StarClose or ProGlide). Patients will be screened and consented
      prior to cardiac catheterization. If the stenting procedure is performed without
      complications and the hemostatic closure device successfully deployed the patient will then
      be evaluated four hours after the completion of the procedure; if there are no complications
      and the patient is able to ambulate, he/she will be randomized and enrolled into either the
      early discharge group (EDG) or the delayed discharge group (DDG). Subjects will not be
      considered enrolled into the study until they have been successfully randomized into either
      the EDG or DDG group. Patients in the early discharge group (EDG, n=200) will be dismissed
      from the hospital six hours after hemostatic closure device deployment if the vital signs are
      stable, no bleeding complications are present, are ambulatory, there are no
      electrocardiographic changes suggestive of myocardial ischemia and/or arrhythmia and are free
      of chest pain. Patients in the delayed discharge group (DDG, n=200) will be dismissed from
      the hospital after the procedure at the discretion of the attending cardiologist but no
      sooner than 24 hours after PCI. Patients with an indication for extended hospital stay will
      not be discharged regardless of randomization. A detailed screening log will be kept to track
      the number of patients screened and consented and will include reason for screening failure
      (exclusion criteria, procedure related complications, closure device failure, access
      complication, chest pain, arrhythmias, hemodynamic instability, etc.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will include four-hundred consented patients undergoing percutaneous coronary
        stenting at the University of Southern California Hospital or LA County Hospital, patients
        in the study group will be discharged the day of the procedure whereas patients in the
        control group will be discharged at the discretion of the attending cardiologist not
        earlier than 24 hours after their procedure. Patients will be stratified on the basis of
        their initial clinical presentation, as determined by the medical history, physical
        examination, ECG and laboratory studies. Patients must be hemodynamically stable, and able
        to understand and sign an informed consent.