Femoral vs radial: critical appraisal of the evidence and what you need to learn as a trainee to do both well

1. Femoral vs. Radial: Critical Appraisal of
the Evidence and What You Need to
Learn as a Trainee to Do Both Well
Robert W. Yeh MD, MSc
Assistant Professor of Medicine
Massachusetts General Hospital
Harvard Medical School

2. Disclosures and Funding
Funding
National Heart, Lung and Blood Institute (1K23HL118138)
American Heart Association (12CRP9010016)
Harvard Clinical Research Institute
Hassenfeld Scholars Grant, Hassenfeld Family
SPARK Grant, MGH Institute for Heart, Vascular and Stroke Care
Innovation Award, Department of Medicine, MGH
Industry Disclosures
Abbott Vascular: Advisory board, Consulting fees
Boston Scientific: Consulting fees
Gilead Sciences: Fees for educational material
Merck: Expert witness testimony
2

3. Overview
• The Changing Transradial Landscape
• Benefits and risks of transradial PCI
– Observational studies
– Randomized clinical trials
– Subgroups with greatest benefit
• Balancing transradial benefits against potentially longer
door-to-balloon times in STEMI
• Integrating transradial access into your practice
• Subgroups where benefit may not be strong

4. Registry Data: Transradial PCI in the UK
4 Katib et al. JACC Intv 2015.

5. Transradial PCI in the US
5
Feldman. Circulation 2013.

6. Hospital Variation
6
Feldman. Circulation 2013.

7. Large Associated Benefit
7
Katib et al. JACC Intv 2015.

8. Is the benefit that strong?
8
Wimmer et al. JACC 2013.
Regression OR 0.16 (0.05 – 0.52)
Matching OR 0.20 (0.04 – 0.71)
IPTW OR 0.07 (0.02 – 0.22)
RCT (RIFLE-STEACS) OR 0.34 (0.16 – 0.68)
Access Site Bleeding
Regression OR 0.48 (0.26 – 0.86)
Matching OR 0.44 (0.20 – 0.93)
IPTW OR 0.46 (0.25 – 0.84)
RCT (RIFLE-STEACS) OR 0.96 (0.53 – 1.74)
Non-Access Site Bleeding (Falsification Endpoint)

9. What about Randomized Evidence
Growing number of trials
• RIVAL (Stable and ACS)
• MATRIX (ACS)
9

10. RIVAL
7021 pts randomized to
radial vs. femoral access.
Negative Trial for primary
endpoint of death, MI,
stroke, nonCABG bleeding
Significantly decrease in
vascular complications
Subgroups showed benefit
10
3.7% vs. 4.0%
Jolly et al. Lancet 2011.

11. MATRIX Primary endpoints
Death, MI, Stroke:
8.8% rad vs. 10.3% fem
HR 0.85 (0.74-0.99)
p= 0.0307
Death, MI, Stroke, BARC
3 or 5 bleeding
9.8% rad vs. 11.7% fem
HR 0.83 (0.73-0.96)
P=0.0092
Valgimigli et al. Lancet 2015.

12. All-cause mortality
8.8% rad vs. 10.3% fem
HR 0.72 (0.53-0.99)
p= 0.0450
Death, MI, Stroke, BARC
3 or 5 bleeding
9.8% rad vs. 11.7% fem
HR 0.67 (0.49-0.92)
P=0.0128

13. STEMI – where access site matters the
most?
Karrowni, et al. JACC Cardiovascular Intv. 2013.

14. RCT Data - Mortality
Karrowni, et al. JACC Cardiovascular Intv. 2013.

15. Mortality Benefit – bleeding mediated?
Is this bleeding mediated?
15
Radial Femoral
Sitting up vs. Lying down after PCI?
Earlier ambulation?

16. Weighting Benefits and Risks of Transradial
PCI
Benefits
• Less access site bleeding
• Ability to anticoagulate
more aggressively?
• Earlier ambulation
• Patient comfort
Risks
• Longer procedures
• More contrast
• Longer fluoro times
• Longer door-to-balloon
times for STEMI

17. Divergence in Guidelines
Hamon, et al. Eurointervention 2013.
O’Gara et al. JACC. 2013.
versus

18. Transradial Use for STEMI in the US
Baklanov, et al. JACC 2013.

19. The concern over door-to-balloon time
Rathore, et al. BMJ. 2009.
Nallamothu, et al. American Journal of Cardiology. 2003.

20. How much delay in DTB time would offset the
mortality benefit of transradial PCI in RCTs?
20
Wimmer,et al. ESC 2013
Input Case Distribution
Type
Details Reference(s)
Mortality at 30-days
Radial PCI Base case Beta 38 deaths, 1455 patients RIVAL(1) and
RIFLE STEACS(2)
Femoral PCI Base case Beta 78 deaths, 1504 patients RIVAL(1) and
RIFLE STEACS(2)
Radial PCI Medicare Triangular Low: 5.2%
Likeliest: 7.2%
Maximum: 9.2%
Medicare analysis(3)
Femoral PCI Medicare Triangular Low: 12.4%
Likeliest: 14.4%
Maximum: 16.4%
Medicare analysis(3)
Per-minute door-to-
balloon mortality-
relationship
Base case Triangular Low: 0.00021
Likeliest: 0.00031
Maximum: 0.00041
NCDR analysis(4)
Medicare
sensitivity
analysis
Triangular Low: 0.00017
Likeliest: 0.00117
Maximum: 0.00217
Medicare analysis(3)
Crossover rate beyond
RIFLE STEACS/RIVAL
Base case - 7.8% implicit in model
12.8%
Crossover
Triangular Low: 0.078
Likeliest: 0.128
Maximum: 0.178
Multiple
cohorts(5,6,7)
17.8% crossover Triangular Low: 0.128
Likeliest: 0.178
Maximum: 0.228
Multiple
cohorts(5,6,7)
Crossover time delay
(minutes)
Additional
crossover
analyses
Triangular Low: 10 minutes
Likeliest: 30 minutes
Maximum: 50 minutes
Expert opinion of
authors

21. It may be worth the extra time
21
83 minutes of
delay in DTB
time offsets the
RCT mortality
benefit of
transradial PCI
0.55 RR from RCTs RR cut to 1/4
21 minutes of
delay

22. Not strongly influenced by crossover
22

23. Integrating Transradial Access in Your STEMI
Practice
Increasing
magnitude
of benefit
for radial!

24. Learning Curve
• Hess et al: New radial operators in US

25. Common Mistakes Trainees Make During
Transradial PCI
Access
• Trying to wire a bad stick
• Sticking too close to the hand
• Not using imaging
Guide Selection and Placement
• Not asking pt to take a deep
breath
• Using too much of the J wire to
position the guide
• Over-torquing a guide that is
not responding
• Choosing a weak guide (left or
right coronary)
– Crossing R to L, and L to R
is stronger
Device Placement
• Proposing small changes to
to address big obstacles.
– Belt and suspenders
– Know and be
comfortable with all the
options (Supportive
wires, guide extension,
anchoring techniques,
larger diameter guides)
• Too timid/too aggressive

26. Common Mistakes Trainees Make During
Transfemoral PCI
Access
• Being too casual about the stick
• Not using imaging to help yourself (fluoro, ultrasound)
• Staying away from it even though you are not succeeding
radially

27. Tailor Access Strategy to the Patient, not to
the Physician.
Radial:
STEMI
High risk of bleeding
Can’t lie flat
Women?
Femoral:
CTO?
Multiple SVGs
Low risk of bleeding

28. Case on Thursday
• 72 yo M with aortobifem
bypass, obese, CKD,
severe PAD, CTO of the
proximal LCx (JCTO 3),
Class III angina.
• No radial pulses palpable,
no flow on US.
• Biulnar access (7.5 F
sheathless antegrade, 6F
retrograde).
• Completed with antegrade
dissection reentry
(Stingray)

29. Conclusions
• Question observational evidence comparing transfemoral and
transradial PCI.
• Randomized clinical trials consistently have shown substantial
reductions vascular access complications with transradial PCI.
• They have also consistently shown a reduction in mortality for
ACS/STEMI patients.
– Societies have recommended transradial as the default approach
in primary PCI
– The magnitude of benefit is greater than expected, and exceeds
the reduction in bleeding and vascular access complications (the a
priori presumed mechanism of benefit)
• The benefits of transradial PCI exceed the potential risks, including the
risk of prolonging door to balloon time.

30. Conclusions
• Integrating the ability to comfortably perform transradial
PCI, especially for the highest risk cases, should be a goal
for all interventionalists who perform primary PCI, as this is
the population that will derive the greatest benefit from the
approach.
• The ability to perform transfemoral PCI safely remains a
critical skill set for interventionalists, even in a radial-
dominant world.

31. Femoral vs. Radial: Critical Appraisal of
the Evidence and What You Need to
Learn as a Trainee to Do Both Well
ryeh@mgh.harvard.edu
Robert W. Yeh MD, MSc
Assistant Professor of Medicine
Massachusetts General Hospital
Harvard Medical School