TransRadial PCI: Advantages, Disadvantages, and Uptake in the U.S. and Abroad. TransRadial Education & Training & Therapy (TREATT) Thinktank.

1. TransRadial PCI: Advantages, Disadvantages,
and Uptake in the U.S. and Abroad
TransRadial Education & Training & Therapy
(TREATT) Thinktank
Duke FDA Meeting
Silver Spring, MD
June 2010
David R. Holmes, MD
Mayo Clinic
Rochester, MN

2. Presenter Disclosure Information
David R. Holmes, Jr., M.D.
“TransRadial PCI: Advantages, Disadvantages, and
Uptake in the U.S. and Abroad”
The following relationships exist related to this presentation:
None

3. Radial Approaches
Issues
• What are the advantages
• Does this approach deliver?
• What are the issues in delivering
it?
• What is arteria subclavia dextra
lusiria?

4. Transfemoral Approach
• Dominant strategy since Dr Melvin Judkins
• Large vessels
• Preformed catheters
• Avoided cutdowns (Brachial artery Sones)
• Could tolerate larger catheter size
• Could be repeated
• Percutaneous
• Anatomy straightforward

5. Transfemoral Approach
• Entry site critical
• Landmarks sometimes very problematic
• The Red Sea
• Space for unrecognized blood collections
• Hemostasis
• Peripheral arterial disease

6. Advantage and Disadvantages
of Transradial Approach to PCI
Advantages
• Reduced bleeding risk
• Reduced length of stay and costs
• Early ambulation
• Improved patient comfort
• Obviates discontinuation of oral anticoagulant therapy
• Same-day discharge possible
Disadvantages
• Learning curve
• Not routinely taught in fellowship programs
• Limits guide catheter size
• Possible greater radiation exposure to operator
• Long-term consequences to radial artery
(eg, for re-access or for use as bypass graft) unknown
Rao SV et al: J Am Coll Cardiol 55:2187, 2010
3047869-6

7. Normal Radial Artery Anatomy
Heart 95:410, 2009

8. Radial Approaches
• Improved patient safety
• Patient comfort – preference
• Simplified post-procedural care
• Decreased length of stay

9. Radial vs Femoral Access
Systematic Review and Meta Analysis
• 23 randomized trials with 7,020 patients
undergoing angiography or PCI
• Endpoints:
• Major bleeding
• Death
• MI
• Procedural or fluoro time
Jolly SS et al, Am Heart J 157:132-40, 2009

10. Radial vs Femoral Access
Systematic Review and Meta Analysis
Endpoints (%) Radial Femoral OR P
Major bleeding 0.05 2.3 0.27 <0.001
Death 1.2 1.8 0.74 0.29
D, MI, Stroke, PCI 2.5 3.8 0.71 0.06
Unable to cross lesions 4.7 3.4 1.29 0.21
Jolly SS et al, Am Heart J 157:132-40, 2009

11. Radial vs Femoral Access
Systematic Review and Meta Analysis
Conclusions: Radial access reduced
major bleeding and there was a
corresponding trend for reduction in
ischemic events compared to femoral
access. Large randomized trials are
needed to confirm the benefit of radial
access on death an ischemic events.
Jolly SS et al, Am Heart J 157:132-40, 2009

12. 3050029-12

13. Radial Approaches
Issues
• Physical set up – arm board
• Radial anomalies
• Learning curve
• LIMA
• Radiation exposure

14. Transradial approach
• How do you introduce it?
• Ergonomics and radiation exposure
• Ergonomics and Left-Right
• Prior CABG
• Hemodynamic support
• What is arteria subclavia dextra lusiria?

20. Radial Artery Anomalies
• 1,540 consecutive patients undergoing first
transradial procedure – angio + PCI
• Retrograde radial angiography performed
Lo TS: Heart 95:410, 2009

21. Radial Artery Anomalies
Clinical characteristics
Mean age (yr) 63.6
M/F 70.6/29.4
PVD 8.8%
Sheath size
5F 50.6
6F 48.0
7F 1.4
RA 93%
Lo TS: Heart 95:410, 2009

22. Radial Artery Anomalies
1,540 patients
13.8% anomalies (212 patients)
Full radial
loop
16.5 Extreme
tortuosity
High-bifurcating 14.1
radial origin
50.9 Misc
18.3
Lo TS: Heart 95:410, 2009

23. Complex Large Radial Artery Loops
Heart 95:410, 2009

24. Radial Artery Loop
“Crossing” Straightening
Heart 95:410, 2009

25. High-Bifurcating Radial Artery that Rejoins the
Brachial Artery at the Middle Third of the Humerus
Heart 95:410, 2009

26. Extreme Radial Artery Tortuosity
Heart 95:410, 2009

27. Radial Artery Anatomy and Procedural Outcome
100 Normal radial anatomy (n=1,321)
Radial anomaly (n=212)
80
P<0.001
60
P=NS
40 P=0.02
20 P<0.001
0
Mean age Women Mean Procedural
(%) procedure failure (%)
Heart 95:410, 2009 time (min)

28. Types of Radial Anomaly and
Their Rates of Procedural Failure
120
Success
100 Failure
80
60
40
20
0
High Radial Tortuosity Others
bifurcation loop
Heart 95:410, 2009

29. High-Bifurcating Radial Artery
Anastomosis Sites and Diameters
Anastomosis Sites Diameters
50
40
30
%
20
10
0
Axillary Upper Mid Lower <2.0 2.0-<2.5 2.5-3.0 >3.0
Humerus mm
Heart 95:410, 2009

30. Radial Artery Anomalies
Procedural failure 14.2 vs 0.9% P<0.001
anomaly vs not
High-radial bifurcation 4.6%
Radial loop 37.1%
Radial tortuosity 23.3%
Misc 12.9%
Lo TS: Heart 95:410, 2009

31. Advantage and Disadvantages
of Transradial Approach to PCI
Advantages
• Reduced bleeding risk
• Reduced length of stay and costs
• Early ambulation
• Improved patient comfort
• Obviates discontinuation of oral anticoagulant therapy
• Same-day discharge possible
Disadvantages
• Learning curve
• Not routinely taught in fellowship programs
• Limits guide catheter size
• Possible greater radiation exposure to operator
• Long-term consequences to radial artery
(eg, for re-access or for use as bypass graft) unknown
Rao SV et al: J Am Coll Cardiol 55:2187, 2010
3047869-31

32. Radial Approaches
Issues
• What are the advantages
• Does this approach deliver?
• What are the issues in delivering
it?
• What is arteria subclavia dextra
lusiria?

34. 3047869-34

36. Transradial Access
Site of Bleeding Complications
CVA
100 2.9 GI
RP
12.5
80 5.9
Hematoma
6.3
60 0.8
%
40 73.4
59
20
0
TIMI major TIMI minor
Rao SV et al: J Am Coll Cardiol 55:2187, 2010
3047869-36

37. Transradial Access
Association Between Vascular Access Site
for PCI and Outcomes
1.31 (0.87-1.96)
(0.87-
Procedure failure
Access site crossover
0.74 (0.42-1.30)
(0.42- 3.82 (2.83-5.15)
(2.83-
Death
0.71 (0.49-1.01)
(0.49-
Death, stroke, or MI
0.27 (0.16-0.45)
(0.16-
Major bleeding
Transradial better 1.0 Transfemoral better
Rao SV et al: J Am Coll Cardiol 55:2187, 2010
3047869-37

38. Transradial Access
Association Between Vascular Access Site
for PCI and Outcomes
1.31 (0.87-1.96)
(0.87-
Procedure failure
Access site crossover
0.74 (0.42-1.30)
(0.42- 3.82 (2.83-5.15)
(2.83-
Death
0.71 (0.49-1.01)
(0.49-
Death, stroke, or MI
0.27 (0.16-0.45)
(0.16-
Major bleeding
Transradial better 1.0 Transfemoral better
Rao SV et al: J Am Coll Cardiol 55:2187, 2010
3047869-38

39. M.O.R.T.A.L. Study
• British Columbia Cardiac Registry study
• 38,872 procedures in 32,822 patients
undergoing PCI
• Purpose: evaluate the association of arterial
access site (radial or femoral) with
transfusion and mortality
Chase AJ et al, Heart 94:1019-1025, 2008

40. M.O.R.T.A.L. Study
Whole Radial Femoral Non-
Non-
Raw outcomes sample cases cases Transfused transfused
whole cohort (n=38,872) (n=7,972) (n=30,900) P (n=967) (n=37,905) P
No. % No. % No. % No. % No. %
Received 967 2.5 108 1.4 859 2.8 <0.01 967 100 <0.01
transfusion
30-day mortality
30- 598 1.5 78 1.0 520 1.7 <0.01 122 12.6 476 1.3 <0.01
1-yr mortality 1,437 3.7 224 2.8 1,213 3.9 <0.01 221 22.9 1,216 3.2 <0.01
Chase AJ et al: Heart 94:1019, 2008
3047177-40

41. M.O.R.T.A.L. Study
Unadjusted Outcome
Transfusion Status Radial vs Femoral
0.25 0.05
0.20 0.04 Femoral
Transfused
Mortality
Mortality
0.15 0.03
0.10 0.02 Radial
0.05 Not transfused 0.01
0.00 0.00
0 100 200 300 400 0 100 200 300 400
Days Days
Chase AJ et al: Heart 94:1019, 2008
3047177-41

42. M.O.R.T.A.L. Study
Conclusions
In a registry of all comers to PCI,
transradial access was associated
with a halving of the transfusion
rate and a reduction in 30-day and
1-year mortality.
Chase AJ et al, Heart 94:1019-1025, 2008

43. Radial Intervention
• RCT of 1005 patients undergoing PCI with
bolus abciximab and uncomplicated
transradial PCI
• Randomization to:
• Same day home discharge no infusion
• Standard 12-hour infusion
• Primary endpoint:
• 30-day D
• MI
• Urgent revasc.
• Major bleeding
• Access site complications
Bertrand OF et al, Circ 114:2636-43, 2006

44. Radial Intervention
Conclusion – Our data
suggest that same-day
1.0 home discharge after
Proportion of patients
uncomplicated transradial
0.8 coronary stenting and
without event
bolus only of abciximab is
0.6 not clinically inferior, in a
wide spectrum of patients,
0.4 Same-day home discharge
Same- to the standard overnight
and single bolus hospitalization and a bolus
0.2 Overnight hospitalization followed by a 12-hour
and bolus + infusion infusion. This novel
0.0 approach offers a safe
0 5 10 15 20 25 30 strategy for same-day
Days to event home discharge after
uncomplicated coronary
intervention.
Bertrand OF et al: Circ 114:2636, 2006
3047025-44

45. Outpatient Discharge Candidates
A Conservative Approach
Clinical Anatomic + Procedural
• Stable AP • SVD
• Asymptomatic + • 1 lesion in MVD
ischemia
• Single stent
• Normal EF
• Uncomplicated
• Pre-loaded with procedure
thienopyridine
SCAI Expert Consensus Document

46. Radial Approaches
Benefits Disadvantages
• Improved patient • Catheter size
safety
• Hemodynamic
• Patient comfort – support
preference
• Operator radiation
• Simplified post
procedure care • Access to LIMA
• Decreased LOS • Training