A randomised comparison of transradial and transfemoral approach for carotid artery stenting: RADCAR study (RADial access for CARotid artery stenting)

1. A randomised comparison of transradial and
transfemoral approach for carotid artery stenting:
RADCAR study (RADial access for CARotid artery
stenting)".
Cardiology Center, Semmelweis University, Budapest, Hungary
Bács-Kiskun County Hospital, Kecskemét, Hungary
Augusta Hospital, Düsseldorf, Germany
Zoltán Ruzsa, Balázs Nemes, Eszter Édes et al.
AimRadial 2014
Chicago

3. Radial access for coronary angiography 2014
Summary: 84,2% !
2247
2111
3020
4319
2332
3231
1990 2006
1498
1480
3336
4663
1677
1481
2825
1838 1952
2681
1913
1466
1799 1884
1855
2011
1456
1786
3933
1251
1381
773
1560 1668
1250
1377
1696
1490
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
6000
5000
4000
3000
2000
1000
0
All coronary angiographies
Transradial coronary angiography

4. Transradial penetration in Hungary
26.9
44.0
53.4
76.6
84.2
90
80
70
60
50
40
30
20
10
0
2007 2008 2009 2010 2014
Radial access (%)

5. Background
Severe access 1 Cannulation problems 2,3
1. Yoo BS. Catheter Cardiovasc Interv. 2002 Jun;56(2):243-5. 2. Gan HW. Catheter Cardiovasc Interv. 2010 Mar 1;75(4):540-3.
3. Shaw JA. Catheter Cardiovasc Interv. 2003 Dec;60(4):566-9.

6. Background (Transradial CAS)
Publication
year
Study Patient
No
Success
(%)
Cross
over
(%)
Asympt
RAO
(n, %)
Major vasc
complication
MACC
E
Pinter et
al. 1
2007 Pilot 20 90 10 5 0 0
Folmar J et
al. 2
2007 Pilot 42 83 ? 0 0 2.3
Patel et al.
3
2010 Pilot 20 80 ? 0 0 5
Bakoyianni
s C et al. 4
2010 Pilot 9 100 0 0 0 0
Mendiz Oa
et al 5
2011 Pilot 79 98.8 ? 0 0 2
Ruzsa et
al. 6
2012 Pilot 68 97.1 2.85 2.94 1.4 1.4
Etxegoien
N et al 7
2013 Pilot 382 91 ? 6 0 0.6
1. Pinter et al. J Vasc Surg. 2007 Jun;45(6):1136-41.
2. Folmar J et al. Catheter Cardiovasc Interv. 2007 Feb 15;69(3):355-61.
3. Patel et al. Catheter Cardiovasc Interv. 2010 Feb 1;75(2):268-75.
4. Bakoyiannis C et al. Int Angiol. 2010 Feb;29(1):41-6.
5. Mendiz OA. Vasc Endovascular Surg. 2011 Aug;45(6):499-503.
6. Ruzsa et al. Cardiologia Hungarica. 2012; 42 : 6–X
7. Etxegoien N. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1081-7.

7. Methods Study population.
- The clinical and angiographic outcomes of 260 consecutive patients with high risk for
carotid endarterectomy (9) treated by CAS with cerebral protection were evaluated in a
prospective randomized multicenter study between 2010 and 2012.
- Patients were randomized to TR (n =130) or TF (n =130) groups.
Endpoints
The following parameters were applied to evaluate the potential advantages of TR
access:
- Primary endpoint: MACCE, rate of major and minor access site complications.
- Secondary endpoints: angiographic outcome of the CAS, and consumption of the
angioplasty equipment, fluoroscopy time and X Ray dose, procedural time,cross over to
another puncture site and hospitalisation days.
Inclusion and exclusion criteria.
- Inclusion criteria were: (1) Symptomatic (history of stroke or transient ischemic attack
within 6 months) internal carotid artery stenosis (>70%) determided by magnetic
resonance imaging or computer tomography and (2) critical asymptomatic (80%) ICA
stenosis.
- Exclusion criteria were: (1) history of acute or recent stroke (<2 months), myocardial
infarction, and surgery or trauma within the preceeding 2 months, (2) unconsiousness or
unwillingness to undergo the procedure, (3) known subclavian or brachiocephalic artery
stenosis, (4) known iliac or common femoral stenosis, (5) contraindications of the
transradial access (Negative Allen test, non-palpable radial artery).

8. 265 surgically high risk patients referred CAS
Inclusion criteria Exclusion criteria
1. Asymptomatic critical ICA stenosis (>80%) 1. History of stroke, AMI and surgery within 2 months
2. Symptomatic significant ICA stenosis (>70%) 2. Unconsciousness and unwillingness to undergo the
procedure
3. Known subclavian or anonym artery stenosis
4. Known iliac and common femoral artery stenosis
5. Contraindication of the radial artery puncture
Randomized and enrolled 260 patients in the study
130 patients for transradial CAS 130 patients for transfemoral CAS
117 (90%) patients
performed from the
primary access
2 patients (1.5%)
performed from
secondary access
13 (10%) patients
performed from
secondary access
128 (98.5%) patients
performed from the
primary access
Excluded 5 patients
Crossover

9. Right sided lesion- Indirect cannulation
Aortography with 15 ml
contrast
Pulling back and rotating
the Simmons catheter
1.
2.

10. Right sided lesion
Selective angiography in AP and LAO90 view

11. Right sided lesion

12. Right sided lesion

13. Left sided lesion- Indirect cannulation
Aortography with 15 ml
contrast
Selective angiography in AP and
LAO90 view
2.
1.

14. Left sided lesion

15. Left sided lesion

16. Bovine arch- direct cannulation
Access: JR 7F
Guiding: 7F JR3,5
Guidewire: Filter wire
Stent: CarotisWallstent 7x30 mm
Balloon: Sterling 4x20 and 6x20 mm

17. Aortic arch II-Loop technique
Access: 7F
Guiding: 7F XF40
Guidewire: Filter wire
Stent: CarotisWallstent 7x30 mm
Balloon: Sterling 5x20 mm

18. Loop technique

19. 19
Demographic and clinical data

20. Angiographic data
20

21. 21
Procedural data

22. Device consumption
22

23. Procedural data
23

24. Complications
24

25. Cross over cases
25

26. Impact of the learning curve (procedure time)
Procedure time
5000
4000
3000
2000
1000
0
Year 1-2-3
PT (min)
26
Year 1 Year 2 Year 3
Time (mean, s) 2338 1752 * 1642 **

27. Impact of the learning curve (Fluoro Time)
27
Fluoro Time
2000
1500
1000
500
0
Year 1-2-3
FT (sec)
Year 1 Year 2 Year 3
Time (mean, s) 767.2 646.3 * 587.7 **

28. Impact of the learning curve (Contrast)
28
Contrast consumption (ml)
250
200
150
100
50
0
Contrast (ml)
Contrast (ml)
Contrast (ml)
Year 1-2-3
Contrast (ml)
Year 1 Year 2 Year 3
Time (mean, s) 137.6 131.6 101.6 *

29. Impact of the learning curve (X Ray dose)
29
X Ray dose
800
600
400
200
0
Year 1-2-3
Dose (mGy)
Year 1 Year 2 Year 3
X Ray (mean, mGy) 259 231 215 *

30. Dual center registry (2008-2014…)
30
Total Femoralis
Total Radialis
300
250
200
150
100
50
0
350
2008
2009
2010
2011
2012
2013
Jun-14
300
200
100
Total Radialis
Total Femoralis
Contrast consumption (ml)
0
Year (1-5 year)
Contrast (ml)

31. RADCAR II flow chart
Design
• DESIGN: Prospective, randomized,
dual-arm, multi-center clinical
evaluation of the transradial access
for carotide artery stenting
• OBJECTIVE: To evaluate the acute
and long-term impact on cerebral
microembolisation during transradial
and transfemoral CAS
• PRINCIPAL INVESTIGATOR
Béla Merkely, MD, PhD, DsC
Zoltán Ruzsa MD, PhD
László Pintér MD
100 patients enrolled between January and
December 2015 in 3 clinical sites in Europe,
Excluded patients
100 with TR or TF CAS
- DW MRI before and after intervention
- Mini Mental test
- TCD
US follow-up at 12
months
Clinical follow-up at 6
months
Clinical follow-up
and MMT at 12
months

32. Conclusion I.
• Carotid artery stenting with cerebral protection devices
can be safely and effectively performed using radial
access with acceptable morbidity and high technical
success.
• Despite the promising early results the TF technique is
superior to TR technique, but the TR technique allows
earlier ambulation than the TF access
• Learning curve plays an important factor in transradial
CAS
• Due to fast mobilisation the patient comfort is better

33. Thank You !!