1. Impact of Radial Access on Bleeding
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
The Medicines Company
Terumo Corporation
Research funding
Cordis Corporation
Momenta Pharmaceuticals
Portola Pharmaceuticals
Off-label uses of drugs/devices will not be discussed

4. Twenty-five year trends in PCI outcomes N=24,410 procedures at the Mayo Clinic
Singh M., et. al. Circulation 2007

5. CRUSADE In-Hospital Outcomes : Last 12 Months
Death %
(Re)-Infarction %
CHF %
Cardiogenic Shock %
Stroke %
RBC Transfusion* %
*Excluding CABG-related transfusions
CRUSADE DATA: January 1, 2006 – December 31, 2006 (n= 29,825)

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

7. 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

8. 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

9. Bleeding in PCI patients
Analysis of 10,974 “real world” patients at 3 centers
TIMI Major (5.4%)
Hemorrhagic strokes 15
Retroperitoneal
Gastrointestinal 63
Hematoma 370
TIMI minor (12.7%)
Gastrointestinal 88
Retroperitoneal 11
Hematoma 823
Transfusion (5.4%)
None (81.9%)
Kinnaird et al Am J Cardio 2003

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

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

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

13. 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

14. Transradial vs. Transfemoral Costs
P < 0.05
P < 0.01
P <

15. 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

17. Radial approach at Duke/Durham VA

18. Conclusions
Radial approach is associated with significant reduction in bleeding
It should not be a hobby – if you are going to do it, then commit to it
But, don’t be dogmatic – the guiding principle should be:
Radial first, femoral as bailout

19. Conclusions Go to a course if available
Duke Transradial Course – July 15-16, 2010 in Durham, NC
SCAI Transradial Mini-course – May 5, 2010 in San Diego, CA
There is an active national and international transradial community who is willing to help
Questions:
Call my cell any time

20. Impact of radial access on bleeding Conclusions
Bleeding complications still occur with some frequency after PCI
At least as common as ischemic events
There is an association between bleeding complications and adverse outcomes
A large proportion of bleeding is related to the vascular access site in patients undergoing PCI

21. Impact of radial access on bleeding Conclusions
Taking the access site out of the equation is incredibly effective at reducing bleeding
50-70% reduction in bleeding with transradial
Significant reduction in costs
The unanswered question is whether this will improve survival among patients undergoing PCI

23. Duke Univ. Medical Center Duke Clinical Research Institute