Same Day Discharge After Coronary Stenting Trial

NCT ID: NCT01054365

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-05-31

Brief 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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Delayed Discharge Group (DDG)

D/C at least 24 hours after procedure or at usual discharge time (n =200)

No interventions assigned to this group

Early Discharge Group (EDG)

D/C 6 hours after procedure if no indication for extended stay after randomization (n=200)

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Leonardo Clavijo

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Clavijo

Director of Interventional Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Leonardo Clavijo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

Other Identifiers

Rev 09-20-09

Identifier Type: -

Identifier Source: org_study_id