Same Day Discharge After Coronary Stenting Trial
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 30 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | December 2009 |
| End Date: | December 2011 |
| Contact: | Leonardo Clavijo, MD, PhD |
| Email: | lclavijo@usc.edu |
| Phone: | 323-442-6130 |
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.
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.
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.
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.
Inclusion Criteria:
- Patients undergoing single and multivessel stenting of type A, B, and C de novo
lesion(s) for the treatment of stable and unstable angina (CCS class I-IV).
- Patients will be treated with thienopyridine oral bolus, either as a pre-treatment or
immediately after stenting, and recommended to be continued on daily.
- Patients will be anticoagulated with intravenous heparin or bilvalirudin during the
procedure and stopped immediately after completion of the procedure.
Arterial access via the femoral artery (Sheath 5, 6, 7 or 8 French) and an arteriotomy
site suitable for hemostatic device closure. Suitability for closure, defined as at least
5 mm from a bifurcation, puncture must not include the artery femoralis profunda or the
superficial femoral artery, TIMI III coronary flow upon completion of the intervention and
Left ventricular ejection fraction (LVEF) less than 40 per cent.
- Patients who live less than an hour away from the hospital.
Exclusion Criteria:
- Age less than 30 years old or greater than 80 years old
- Acute STEMI
- Non-STEMI with documented troponin greater than 10 at presentation to the
catheterization laboratory
- Cardiogenic shock or hemodynamic instability
- Severe valvular heart disease
- Any contraindication to anticoagulation
- Pregnancy
- Patients with bleeding diathesis (including thrombocytopenia (platelets less than
100,000), thrombasthenia, Von WilleBrand's disease, or anemia (Hgb less than 10 mg
per dl, Hct less than 30) or coagulopathy
- Patients with a Creatinine greater than 1.5 mg/ml
- Patients with an INR greater than 1.5
- Patients with cancer or autoimmune disease
- Patients who live greater than 60 minutes away from the hospital
- Patients who will not be able to follow-up
- Patients with inadequate social or home support (homeless, lives alone, etc)
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