EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding
Status:
Unknown status
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
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.