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

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.

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