EASY-B2B: EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bivalirudin Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h |
Drug: Bivalirudin
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
Other Names:
|
| Active Comparator: Heparin 70 U/kg or standard practice |
Drug: Heparin
70 U/kg
|
Outcome Measures
Primary Outcome Measures
- Major bleeding and Mace [24h post-PCI and Discharge]
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)
Secondary Outcome Measures
- EFFICACY and SAFETY PARAMETERS [30 days]
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
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Quebec Heart-Lung Institute | Quebec | Canada | G1V 4G5 |
Sponsors and Collaborators
- Laval University
Investigators
- Principal Investigator: Olivier F Bertrand, MD, PhD, Fondation IUCPQ
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EASY-B2B