EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding (EASY-B2B)

Laval University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Heparin; Drug: Bivalirudin

Study type: Interventional

Funder types: Other

Identifiers

NCT01084993

EASY-B2B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Bivalirudin

Active Comparator group

Description:

Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h

Treatment:

Drug: Bivalirudin

Heparin

Active Comparator group

Description:

70 U/kg or standard practice

Treatment:

Drug: Heparin