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

NCT00169819 | Completed Phase 4 DMC

• 2 other identifiers: H4S-CA-0050ISRCTN72335887
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Ischemia

Keywords

Same day discharge; Trans-radial; Coronary artery stenting; Abciximab bolus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

Abciximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Eli Lilly and Company: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Laval Hospital Research Center

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Related Publications (2)

• Bertrand OF, De Larochelliere R, Rodes-Cabau J, Proulx G, Gleeton O, Nguyen CM, Dery JP, Barbeau G, Noel B, Larose E, Poirier P, Roy L; Early Discharge After Transradial Stenting of Coronary Arteries Study Investigators. A randomized study comparing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation. Circulation. 2006 Dec 12;114(24):2636-43. doi: 10.1161/CIRCULATIONAHA.106.638627. Epub 2006 Dec 4.

  PMID: 17145988 RESULT

• Rinfret S, Kennedy WA, Lachaine J, Lemay A, Rodes-Cabau J, Cohen DJ, Costerousse O, Bertrand OF. Economic impact of same-day home discharge after uncomplicated transradial percutaneous coronary intervention and bolus-only abciximab regimen. JACC Cardiovasc Interv. 2010 Oct;3(10):1011-9. doi: 10.1016/j.jcin.2010.07.011.

  PMID: 20965458 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Ischemia

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Olivier F Bertrand, MD, PhD

  Laval Hospital Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2003
• Study Completion: April 1, 2006
• Last Updated: February 26, 2007

Record last verified: 2007-02

Locations

CA (1)