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

NCT ID: NCT00169819

Last Updated: 2007-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2006-04-30

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.

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.

Conditions

Coronary Artery Disease; Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Abciximab

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Principal Investigators

Olivier F Bertrand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval Hospital Research Center

Locations

Laval Hospital Research Center

Sainte-Foy, Quebec, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 17145988 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20965458 (View on PubMed)

Other Identifiers

ISRCTN72335887

Identifier Type: -

Identifier Source: secondary_id

H4S-CA-0050

Identifier Type: -

Identifier Source: org_study_id