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Same Day Discharge After Coronary Stenting Trial

2014-07-23 21:11:01 | BioPortfolio

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Coronary Artery Disease

Location

University of Southern California
Los Angeles
California
United States
90033

Status

Recruiting

Source

University of Southern California

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:01-0400

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