Early Discharge after Transradial Stenting of Coronary Arteries: Bivalirudin to Reduce Bleeding (The EASY-B2B Trial)

1. EArly Discharge after Transradial
Stenting of CoronarY Arteries:
Bivalirudin to Reduce Bleeding-
The EASY-B2B Trial
Olivier F. Bertrand, MD, PhD
Associate-Professor of Medicine, Laval University
Adjunct-Professor, Department of Mechanical Engineering, McGill University
Quebec Heart-Lung Institute
TCT-2011

2. Disclosures
Research grants: Cordis, Eli-Lilly, Bristol-Myers-
Squibb, GE Healthcare, Sanofi-Aventis, Eurocor
Consultant: Cordis, Astra-Zeneca, Opsens
Research-Scholar from Quebec Foundation for
Health Research
Funding: QHLI Foundation, Laval University
Transradial Research & Education Fund

3. 89%

4. Verheugt JACC Cardio Interv 2011;4:191-7

5. Verheugt JACC Cardio Interv 2011;4:191-7

6. EXCLUSION
- PPCI
- RECENT BLEED
- CREAT CL < 30 ML/MIN
- PLT < 70.000
- CHRONIC AC
G PATTI ET AL. ACC 2011

10. ANTITHROMBOTIC REGIMENS AND RESIDUAL BLEEDING RISK
HAMON ET AL. EUROINTERVENTION, 2009

11. Objective
In patients at high risk of
bleeding and undergoing
transradial PCI, bivalirudin
has a better safety/efficacy
profile compared to heparin

12. EASY B2B-Design
Patients at high risk of non-access site bleeding: ≥
2 risk-factors: Age > 70, female, CKD, recent GI or
organ bleeding, anemia, diabetes, prior GPI/Tnk.
≃ 2500 Transradial PCI
BAIL-OUT GPI
HEPARIN BIVALIRUDIN
1ST END-POINT: DEATH, MI, URGENT
REVASCULARIZATION,
BARC BLEEDING 2,3,5 AT 30 DAYS FU

13. Results: Population Characteristics
Age (years) 77 ± 9
Weight (kg) 73 ± 16
Previous MI 29%
Previous PCI 29%
Previous CABG 11%
Stable Angina 10%
Unstable Angina 46%
NSTEMI 38%
STEMI 7%
Antithrombotic Rx upon arrival
- heparin (iv) .
- LMWH . 44%
- Fondaparinux. 22%
- Tnk/GPI 6%
5.8%

14. Results: Population Characteristics

15. Results: Population Characteristics

16. OF BERTRAND-QC, CANADA
T MANN-RALEIGH, NC, US

17. Conclusion:
Residual bleeding risk remains a serious issue
Bleedings risks non-associated with PCI
procedures are frequent
Strategies to reduce residual bleeding risk
remains to be defined
Benefit of bivalirudin-monotherapy compared
to heparin-monotherapy in patients at high
residual bleeding risk remains to be
demonstrated