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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laval University
• Collaborators: Bristol-Myers Squibb; Eli Lilly and Company
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

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