Coronary Artery Disease
Conditions
Keywords
Coronary artery stenting, transradial, intracoronary
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.
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.
Interventions
DRUGBivalirudin
Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
DRUGHeparin
70 U/kg
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactOlivier F Bertrand, MD, PhD
Backup ContactMichele Jadin, MSc
Outcome results
None listed