EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding

Study Overview
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Brief Summary
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RATIONALE: Transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach. Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. Whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding. Peri-procedural anemia is also an independent predictor of mortality and MACE. With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been associated with a significant reduction in access-site and non-access site related bleeding. In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins IIb-IIIa. HYPOTHESES: In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa. In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.

Detailed Description
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OBJECTIVES: The primary objective is to compare the incidence of major bleeding and anemia 24h post-PCI in patients at high-risk of bleeding after transradial PCI with heparin or bivalirudin.

Official Title
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EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Bivalirudin
* Drug: Heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least two of the following additional criteria At least 70 yrs old Female gender Diabetes Creatinine clearance <60mL/min History of gastro-intestinal or other organ bleeding Baseline anemia Current treatment with glycoproteins IIb-IIIa inhibitors Exclusion Criteria: Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months Concurrent participation in other investigational study Femoral sheath (artery)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bivalirudin<br>Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h | Drug: Bivalirudin<br>* Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h<br>* Other names: Angiomax;|
| Active Comparator: Heparin<br>70 U/kg or standard practice | Drug: Heparin<br>* 70 U/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding and Mace | The primary end-points will be 1) the incidence of major bleeding (Replace-2 criteria) at hospital discharge and 2) the incidence of 24h post-PCI anemia (WHO criteria) | 24h post-PCI and Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFICACY and SAFETY PARAMETERS | The composite of death, MI (def 1 : Tn-t > 0.1 and def 2 : CK-MB > 30μg/l), urgent revascularization and major bleeding at 30 days post-PCI. The incidence of ARC-defined stent thrombosis at 30 days. The incidence of access-site hematoma according to EASY scale. The incidence of radial artery occlusion at hospital discharge according to echo-doppler evaluation | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery stenting, transradial, intracoronary