EArly Discharge After Transradial Stenting of CoronarY Arteries: The EASY Study

February 23, 2007 updated by: Laval University

A Randomized Trial Comparing Same Day Discharge and a Single Bolus of Abciximab to Overnight Hospitalization and Bolus + Perfusion Abciximab After Uncomplicated Trans-Radial Coronary Artery Stenting

HYPOTHESES

Discharge on the same day after uncomplicated trans-radial coronary artery stenting is safe and effective.
Hospitalized patients can be safely returned to the referring center the same day following trans-radial coronary artery stenting.
Abciximab given as a single bolus with optimal trans-radial coronary artery stenting is as safe and effective as bolus + 12 hrs perfusion and does not hamper early discharge.
Same-day discharge is cost-effective and increases patient satisfaction.

OBJECTIVES AND END-POINTS

The objectives of the present study are to assess the effectiveness and safety of same day hospital discharge after uncomplicated coronary artery stenting when a single bolus of Abciximab is used. The primary end-point of the study is the composite of death, myocardial infarction, repeat hospitalization, urgent revascularization, severe thrombocytopenia, access site complications and major bleedings at 30 days following stent implantation.

The secondary end-point is the composite of death, myocardial infarction, repeat target vessel revascularization at 30 days, 6 months and 1 year following stent implantation. Other secondary end-points include the total hospital stay (days) between the index procedure and the first 30 days follow-up, the number of unsolicited medical visits in relation with the percutaneous procedure, index of patient satisfaction and direct and indirect costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Abciximab

Detailed Description

Despite significant improvements in clinical results associated with the current use of stenting and pharmacologic agents there has been little modification in hospitalization duration after percutaneous coronary interventions (PCI). The main reasons associated with prolonged hospitalization after PCI remain 1) the fear of abrupt vessel closure and its associated morbidity 2) the need for prolonged bed rest in case of femoral approach even after use of device closures.

The introduction of coronary stents has been associated with a dramatic decrease in vessel closure once it was recognized that stent deployment required higher pressure balloon inflation and increased antiplatelet therapy. Trans-radial coronary interventions appear safer and more cost-effective than femoral PCI. However, the current use of IIb-IIIa inhibitors prohibits the early discharge of patients following PCI because their pharmacology generally imposes to pursue drug infusion between 18 and 24 hrs following PCI which does not allow same day discharge from the hospital. With Abciximab, however, pharmacologic data indicate that prolonged platelet inhibition (≥ 80%) occurs after a single bolus. Based on the EPIC trial results, it has been recommended to prolong platelet inhibition by a 12 hrs perfusion. By analyzing carefully the EPIC trial results, we hypothesized that after optimal stenting result, a single bolus of Abciximab would suffice. We aim to demonstrate that (1) with trans-radial coronary stenting at least 50% of the entire population referred for PCI could be safely discharged after a few hours observation; (2) a single bolus of Abciximab is at least as effective as current recommended treatment with a bolus + 12 hrs perfusion after uncomplicated stenting. This new regimen could significantly affect current practice, decrease hospital costs and increase patient satisfaction after PCI.

STUDY DESIGN

A prospective randomized single-center study comparing same day hospital discharge to overnight hospitalization after uncomplicated trans-radial coronary artery stenting. Out-patients will be randomized after successful stent implantation to same day discharge or will remain hospitalized at Laval Hospital until the next morning. Hospitalized patients will be randomized after successful stent implantation to either same day discharge at home or to overnight hospitalization (either at the referring center or at Laval Hospital). All eligible patients will be treated with Abciximab that will be administered according to 2 different arms: For patients randomized to same-day discharge, only a bolus of Abciximab will be given, whereas for all remaining patients, Abciximab will be given according to current practice i.e. bolus + 12 hrs perfusion. All patients which will not be eligible post-PCI will enter a registry.

Study Type

Interventional

Enrollment

1000

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Quebec
  - Sainte-Foy, Quebec, Canada, G1V 4G5
    - Laval Hospital Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with documented ischemic coronary artery disease and scheduled for possible coronary artery stenting are eligible.
Patient must be > 18 years of age.
Patient and treating interventional cardiologist agree for randomization.
Patient will be informed of the randomization process and will sign an informed consent.
Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.

Exclusion Criteria:

CLINICAL:

Patients with recent (< 72 hrs) Q-wave (ST elevation) acute myocardial infarction.
History of LV ejection fraction ≤ 30%.
Unstable clinical condition.
Any complication compromising ambulation
Concurrent participation in other investigational study requiring prolonged hospitalization
Required prolonged hospitalization
In-cath lab transient vessel closure
Resuscitation per PCI
Hemodynamic collapse during PCI
Severe entry site complication upon investigator decision
Social isolation
Serious cognitive disorders
Femoral sheath (artery)
Persisting chest pain
No ASA prior PCI
Allergy to ASA or thienopyridines precluding treatment for 30 days
Any significant blood dyscrasia
PCI without stent implantation (except for bifurcation lesion or re-dilatation for in-stent restenosis)
International Normalised Ratio (INR) > 2.0
Contraindication to Reopro administration

ANGIOGRAPHIC

Residual dissection of grade ≥ B of NHBLI classification.
Compromised or sub-occluded branch with diameter ≥ 1 mm.
Timi < 3 post-stenting
Thrombus post-PCI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Death, Q & non-Q myocardial infarction (MI), urgent revascularization, repeat hospitalization, severe thrombocytopenia, access site complications, major bleedings, at 30-days.

Secondary Outcome Measures

Outcome Measure
Death, Q & non-Q MI, repeat target vessel revascularization at 30-days, 6 and 12 mo. Length of hospital stay & unsolicited medical visits at 30-days. Patient satisfaction within 24 hrs and at 30 days, 6 and 12 mo. Direct/indirect cost.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Bristol-Myers Squibb

Eli Lilly and Company

Investigators

Principal Investigator: Olivier F Bertrand, MD, PhD, Laval Hospital Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

February 26, 2007

Last Update Submitted That Met QC Criteria

February 23, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

H4S-CA-0050
ISRCTN72335887

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.