Coronary Artery Disease Clinical Trial
Official title:
EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study
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.
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.
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