1. The TREAT Study: Can Devices Lower Bleeding Rates?
Sunil V. Rao MD
Assistant Professor of Medicine
Duke University Medical Center
Durham VA Medical Center
Duke Clinical Research Institute

2. Sunil V. Rao, MD DISCLOSURES Consulting Fees Honoraria
The Medicines Company, Bristol-Myers Squibb, Astra Zeneca
Honoraria
sanofi-aventis U.S. LLC
Grants/Contracted Research
Cordis, a Johnson & Johnson company, Momenta Pharmaceuticals, Inc., Portola Pharmaceuticals, Inc.
I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation.
I intend to reference Bivalirudin and Fondaparinux for ACS; Enoxaparin for PCI; Clopidogrel for stenting.

3. Disclosures Consultant, Speakers’ Bureau, Honoraria
Sanofi-Aventis, Bristol Myers Squibb
The Medicines Company
Terumo Corporation
Astra Zeneca
Research funding
Cordis Corporation
Momenta Pharmaceuticals
Portola Pharmaceuticals
Off-label uses of drugs/devices will not be discussed

4. Rationale Bleeding is a common complication
Bleeding is associated with short- and long-term morbidity and mortality
Bleeding most commonly occurs at the vascular access site in pts undergoing PCI
Bleeding limits the clinical use of certain antithrombotic therapies

5. Why bleeding? - In Hospital PCI Mortality & Bleeding
Peterson ED ACC 2007
Mehta SR ACC 2007

6. Kaplan Meier Curves for 30-Day Death, Stratified by Bleed Severity
Bleeding & Outcomes N=26,452 pts from PURSUIT, GUSTO IIb, PARAGON A & B
Kaplan Meier Curves for 30-Day Death, Stratified by Bleed Severity
log rank p-value for all four categories <0.0001
log-rank p-value for no bleeding vs. mild bleeding = 0.02
log-rank p-value for mild vs. moderate bleeding <0.0001
log-rank p-value for moderate vs. severe <0.001
Rao SV, et al. Am J Cardiol. 2005

7. PCI-related complications and costs N=335,477 Medicare pts undergoing PCI in 2002
Given the incidence of vascular complications and the cost per complication, this is roughly $117.6 million dollars in costs
Kugelmass A, et. al. AJC 2006

8. Bleeding in PCI Trials: Frequency and site*
Among bleeders
*All transfemoral access
Rao SV, et. al., JACC 2010 (in press)

9. Bleeding in NSTEMI Overall Among bleeders
Access site bleeds are 29.8% of all bleeds
Rao SV, et. al., JACC 2010 (in press)

10. Bleeding in STEMI
Among bleeders
Rao SV, et. al., JACC 2010 (in press)

11. Transradial access and outcomes N=21 studies, 5600 patients
1.0
Transfemoral better
Transradial better
PCI Failure
Access site crossover
Death
Death, CVA, or MI
Major bleeding
0.27 ( )
0.71 ( )
0.74 ( )
3.82 ( )
1.31 ( )
Jolly SS, AHJ 2008

12. The design
The goal: Can transradial reduce bleeding with accepted/approved antithrombotics and INFORM THE LABEL?
TransRadial Eduction And Therapy (TREAT) Program
A series of programs that includes both prospective clinical investigations and educational programs
Prospective registry
Uses NCDR CathPCI as a backbone
Site identification
Data collection with 1-2 unique pages

13. Prevalence of radial approach in the US
N = 593,094 PCI procedures
606 sites
1.3% of all PCI procedures
Rao SV, et. al. JACC: CI 2008

15. TREAT - Challenges Low penetration of transradial in the US
“E” part of the TREAT
Sampling of various antithrombotic agents and class effect of radial?
Does an effect in one agent translate to an effect in another in the same class?
Is it reasonable to expect that data from a registry is sufficient to inform drug labeling?
Some agents of interest are in the last phase of the product life cycle