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

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.

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

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

CRUSADE In-Hospital Outcomes : Last 12 Months Death 3.6% (Re)-Infarction 1.8% CHF 6.6% Cardiogenic Shock 2.2% Stroke 0.7% RBC Transfusion* 9.1% *Excluding CABG-related transfusions CRUSADE DATA: January 1, 2006 – December 31, 2006 (n= 29,825)

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

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

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

Bleeding in PCI patients Analysis of 10,974 “real world” patients at 3 centers TIMI Major 588 (5.4%) Hemorrhagic strokes 15 Retroperitoneal 30 Gastrointestinal 63 Hematoma 370 TIMI minor 1394 (12.7%) Gastrointestinal 88 Retroperitoneal 11 Hematoma 823 Transfusion (5.4%) None 8992 (81.9%) Kinnaird et al Am J Cardio 2003

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

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

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

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 (0.16-0.45) 0.71 (0.49-1.01) 0.74 (0.42-1.30) 3.82 (2.83-5.15) 1.31 (0.87-1.96) Jolly SS, AHJ 2008

Transradial vs. Transfemoral Costs P < 0.05 P < 0.01 P < 0.0001

Prevalence of radial approach in the US N = 593,094 PCI procedures 2004-2007 606 sites 1.3% of all PCI procedures Rao SV, et. al. JACC: CI 2008

Radial approach at Duke/Durham VA

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

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 919-812-4051 any time Email sunil.rao@duke.edu

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

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

Duke Univ. Medical Center Duke Clinical Research Institute