Overview of Transradial PCI in the US

1. Overview of transradial PCI in the
US
Sunil V. Rao MD FACC FSCAI
Duke Clinical Research Institute
Durham VA Medical Center

2. Disclosures
 Consultant, Honoraria
 Sanofi-Aventis/BMS, The Medicines
Company, Terumo Corporation, Astra
Zeneca, Eli Lilly/Daiichi-Sankyo, Zoll
 Research funding
 Cordis Corporation, Ikaria
 Off-label uses
 May be discussed in this presentation

3. Overview of Transradial PCI in the US
 Where have we been?
 Where are we now?
 TRI Practice Patterns
 Future directions for transradial in the US

4. 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

5. CATH-PCI Registry: Trend in the Use of radial PCI Over
Time in Key Subgroups
n=593,094
Radial access: 1.32%
Rao SV, et. al. JACC: CI 2008
Rao, S. V. et al. J Am Coll Cardiol Intv 2008;1:379-386

6. Adoption of TRI since 2007
N=1,037,639 pts in NCDR CathPCI Registry
12 11%
10
8
%
6
4
1.4%
2
0
QTR QTR QTR QTR QTR QTR QTR QTR QTR QTR QTR QTR QTR QTR QTR QTR QTR
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1
2007 2007 2007 2007 2008 2008 2008 2008 2009 2009 2009 2009 2010 2010 2010 2010 2011
Data courtesy of DCRI & ACC NCDR

7. Transradial at TCT 2010

8. SCAI 2011

9. Transradial courses 2011

10. Transradial literature 2004-2011
2004-2007
2008-2011

11. Transradial: Lessons learned from recent trials
Summary
 Hydophilic sheaths reduce radial spasm (sheath length has no
effect)1
 Left radial approach is associated with reduced radiation exposure
and lower femoral crossover2
 UFH dosing reduces RAO; Ulnar compression may reduce even
further3
 Radial not associated with reduced mortality in lower risk ACS
patients4
 Low rates of bleeding overall; higher rate of non-access site
bleeding
 Patients prefer radial
 High volume radial centers have better outcomes
 Radial associated with reduced mortality in primary PCI
1Rathore S, et. al. JACC:CI 2010
2Sciahbasi, et. al. AHJ 2011
3Bernat I, et. al. AJC 2011
4Jolly SS, et. al. Lancet 2011

12. Contemporary TRI practice in the US
N=421,610 pts from NCDR CathPCI Jan 2010-Mar 2011
Femoral Radial P
N=392898 N=28712
Median age, yrs 66.0 64.0 < 0.0001
Female 33.5 30.5 < 0.0001
Mean BMI, kg/m2 30 31 < 0.0001
Diabetes 37.4 36.9 < 0.0001
PAD 37.4 36.9 < 0.0001
Prior PCI 38.8 35.3 < 0.0001
Prior CABG 20.5 9.3 < 0.0001
CKD 2.5 1.1 < 0.0001
Ad hoc PCI 83.9 86.3 < 0.0001
Data courtesy of DCRI & ACC NCDR

13. Contemporary TRI practice in the US
N=421,610 pts from NCDR CathPCI Jan 2010-Mar 2011
% Radial by Region
N=28,712
10.2
Northeast
25.7 South
25.9 Midwest
West
38.2
Data courtesy of DCRI & ACC NCDR

14. Contemporary TRI practice in the US
N=421,610 pts from NCDR CathPCI Jan 2010-Mar 2011
Procedure characteristics
16 1400 186
14.7
1243 185
14 185
1200
184
12 11.3
1000
183
Contrast vol, mL
Fluoro time, min
Fluoro dose, mGy
10
800 737 182
8
181
600
6 180
180
400
4 179
2 200 178
177
0 0 Femoral Radial
Femoral Radial Femoral Radial
Data courtesy of DCRI & ACC NCDR

15. Contemporary TRI practice in the US
N=421,610 pts from NCDR CathPCI Jan 2010-Mar 2011
Procedure characteristics
Femoral Radial
60
52.9
50 48.1 47
45.5
40
%
30
20
15.2
13.7
10
P < 0.0001 P < 0.0001 P < 0.0001
0
Multivessel CAD MV PCI High-risk lesion
Data courtesy of DCRI & ACC NCDR

16. Contemporary TRI practice in the US
N=421,610 pts from NCDR CathPCI Jan 2010-Mar 2011
Procedural antithrombotic therapy
Femoral Radial
90
78.4 77.6
80 75.4
70
61.1
60
50 44.2 42.6
%
40
30
22.9 23.8
20
9.2 10.8
10 P < 0.001 P < 0.001 P < 0.001 P < 0.001 P < 0.001
0
UFH Bivalirudin 2b3a Clopidogrel Prasugrel
Data courtesy of DCRI & ACC NCDR

17. Contemporary TRI practice in the US
N=421,610 pts from NCDR CathPCI Jan 2010-Mar 2011
Procedure outcomes
Femoral Radial
2 1.9
1.8
1.6
1.4
1.4
1.2 1.1
%
1
0.8
0.6
0.6
0.45
0.4
0.2 0.15
P < 0.0001 P < 0.0001 P < 0.0001
0
Bleeding Transfusion Vascular complications
Data courtesy of DCRI & ACC NCDR

18. Contemporary TRI practice in the US
N=421,610 pts from NCDR CathPCI Jan 2010-Mar 2011
Post-PCI Length of Stay
Femoral Radial
<2
days
3% <2
≥4 ≥ 4 days days
days 9%
14% 8%
2-3
days 2-3 days
83% 83%
Data courtesy of DCRI & ACC NCDR

20. Female gender and access site complications
Ahmed B, et. al. Circulation 2009

21. Slide courtesy of Olivier Bertrand MD

22. Study of Access site For Enhancing PCI for
Women (SAFE-PCI for Women)*
Female patient undergoing urgent or elective PCI
Best background medical therapy
Bivalirudin, Clopidogrel, Prasugrel
2b3a at investigator’s discretion
N=2000 pts, 30 sites
Sites from NCRI
Radial Patent hemostasis required Femoral
Vascular closure devices allowed
Primary Efficacy Endpoint: BARC Types 2, 3, or 5 bleeding or Vascular
Complications requiring surgical intervention
Primary Feasibility Endpoint: Procedural failure
Secondary endpoints: Procedure duration, total radiation dose, total contrast
volume
*Planned in collaboration with ACC, CSRC, FDA Office of Women’s Health

23. Transradial Outside the US
Future directions – Clinical trials
 Will transradial reduce mortality in STEMI and preserve door-to-
balloon times?
 STEMI Radial Trial
 What is the role of anticoagulation when radial approach is used?
 EASY B2B Trial
 MATRIX Trial

24. Landscape of Transradial in the US
Summary
 The radial approach has increased significantly in
the US (10-fold increase in 4 years)
 Being used predominantly in lower risk patients
 Less often used with pharmacological BAS
 Predictions are hard, especially about the future
 Device innovation
 Better evidence
“The practice of medicine should be based on science;
“The ‘art’ of medicine is in how you interact with the patient.
- Robert M. Califf MD

25. Duke Univ. Medical Center
Duke Clinical Research
Institute