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Comparison of transradial and transfemoral
approach for carotid artery stenting: RADCAR study
(RADial access for CARotide artery stenting)
Cardiology Center, Semmelweis University, Budapest, Hungary
Båcs-Kiskun County Hospital, Kecskemét, Hungary
Augusta Hospital, DĂŒsseldorf, Germany
Zoltån Ruzsa, Balåzs Nemes, Låszló Pintér,
BalĂĄzs Berta, KĂĄroly TĂłth, Barna Teleki, SĂĄndor Nardai, ZoltĂĄn Jambrik,
György SzabĂł, Ralf Kolvenbach, KĂĄlmĂĄn HĂŒttl, BĂ©la Merkely

AimRadial 2013
New York
Disclosure Statement of
Financial Interest
I, ZoltĂĄn Ruzsa MD. PhD.
DO NOT have a financial interest/arrangement or
affiliation with one or more organizations that
could be perceived as a real or apparent conflict of
interest in the context of the subject of this
presentation.
Background
Severe access 1

1. Yoo BS. Catheter Cardiovasc Interv. 2002 Jun;56(2):243-5.

Cannulation problems 3,4

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.
Background (Transradial CAS)
Publication
year

Study

Patient
No

Success
(%)

Cross over
(%)

Asympt
RAO
(n, %)

Major vasc
complication

MACCE

Pinter et al.

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

Bakoyiannis
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.

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

6

1.
2.
3.
4.
5.
6.
7.

Pinter et al. J Vasc Surg. 2007 Jun;45(6):1136-41.
Folmar J et al. Catheter Cardiovasc Interv. 2007 Feb 15;69(3):355-61.
Patel et al. Catheter Cardiovasc Interv. 2010 Feb 1;75(2):268-75.
Bakoyiannis C et al. Int Angiol. 2010 Feb;29(1):41-6.
Mendiz OA. Vasc Endovascular Surg. 2011 Aug;45(6):499-503.
Ruzsa et al. Cardiologia Hungarica. 2012; 42 : 6–X
Etxegoien N. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1081-7.
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).
Right sided lesion
Pulling back and rotating
Aortography with 15 ml
the Simmons catheter
contrast

2.

1.
Right sided lesion
Selective angiography in AP and LAO90 view
Right sided lesion
Right sided lesion
Left sided lesion
Aortography with 15 ml
contrast

2.

1.

Selective angiography in AP and
LAO90 view
Left sided lesion
Left sided lesion
Demographic and clinical data of all study patients
Radial

group Femoral

group P value

(n=130)

(n=130)

Age

66.8±8.9

66.7±10.2

0.856

Male (%)

60.8

65.4

0.441

Hypertension (%)

77.7

88.5

0.021

Hyperlipidaemia (%)

56.2

47.7

0.172

Diabetes mellitus (%)

36.2

36.9

0.898

Obesity (%)

14.6

34.6

0.0003

Smoker (%)

28.5

26.9

0.889

Peripheral artery disease (%)

13.9

13.8

1.000

Coronary artery disease (%)

24.6

24.6

0.776

Positive family history (%)

6.9

9.2

0.495

Dialysis (%)

6.2

3.1

0.237
Angiographic data
Radial group

Femoral group

(n=117)

p value

(n=128)

Aortic arch morphology
Arch type I. n (%)

79 (67.5)

108 (84.4)

0.002

Arch type II-III n (%)

38 (32.5)

20 (15.6)

0.073

0.131

Stenosis localisation

-

Left sided n (%)

50 (42.7)

75 (58.6)

-

Right sided n (%)

67 (57.3)

53 (41.4)

Reference diameter (ICA) (mm)

5.7±0.9

5.7±0.9

0.854

Stenosis diameter (%)

81.9

84.1

0.286
Procedural data
Successful puncture in all patients n (%)

128 (98.5)

130 (100.0)

0.156

Successful cannulation n (%)

119 (91.5)

129 (99.2)

0.003

Successful procedure from primary access n (%)

117 (90.0)

128 (98.5)

0.003

Cross over n (%)

10.0

1.5

0.003

Puncture time (sec)

30±48

25±19

0.347

Cannulation time (sec)

118±152

93±95

0.141

Procedure time (sec)

1744±742

1665±744

0.409

X Ray dose (mGy)

223±138

182±106

0.008

Fluoroscopy time (sec)

613±289

579±285

0.359

Contrast volume (ml)

117.9±39.3

110.1±36.3

0.111

Hospitalization days

1.17±0.40

1.25±0.45

0.006

Consumption of devices
Diagnostic catheter / procedure (%)

122 (104.3)

110 (85.9)

0.011

Guide catheter / procedure (%)

108 (92.3)

77 (60.2)

<0.001

Guiding sheath (%)

9 (7.7)

51 (39.8)

<0.001

Buddy wire (%)

45 (38.5)

69 (53.9)

0.016

Balloon / procedure (%)

128 (109.4)

147 (114.8)

0.355

Stent used / procedure (%)

112 (95.7)

126 (98.4)

0.204
MACCE (Major Adverse Cerebral and Cardiac Events)
Radial group (n=117)

Femoral group (n=128)

p value

MACCE n (%)

1 (0.9)

1 (0.8)

0.949

-

Death

1 (0.9)

0 (0.0)

0.295

-

Myocardial infarction

0 (0.0)

0 (0.0)

1.000

-

Reintervention

0 (0.0)

0 (0.0)

1.000

-

Stroke

1 (0.9)

1 (0.8)

0.949

Vascular complications
Minor n (%)

9 (7.7)

6 (4.7)

0.327

-

Spasm

0 (0.0)

0 (0.0)

1.000

-

Haematoma

1 (0.9)

6 (4.7)

0.072

-

Asymptomatic RAO

8 (6.8)

0 (0.0)

0.003

-

Other

0 (0.0)

0 (0.0)

1.000

1 (0.9)

1 (0.8)

0.949

Major n (%)
-

Symptomatic RAO

1 (0.9)

0 (0.0)

0.295

-

Bleeding and compartment syndrome

0 (0.0)

1 (0.8)

0.338

-

Other

0 (0.0)

0 (0.0)

1.000

10 (8.6)

7 (5.5)

0.344

Total vascular complication n (%)
Conclusion
‱ 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
‱ In severe PAD, tortuose iliac artery and aortic arch
abnormalities (Bovine arch, Arch II-III) the transradial
angioplasty can be better than transfemoral
angioplasty
‱ It can minimaize the potential embolisation from aortic
arch
‱ Due to fast mobilisation the patient comfort is better
Thank You !!
Case 1.- Bovine arch direct cannulation
Access: JR 7F
Guiding: 7F JR3,5
Guidewire: Filter wire
Stent: Carotis Wallstent 7x30 mm
Balloon: Sterling 4x20 and 6x20 mm
Case 2.-Loop technique
Access: 7F
Guiding: 7F XF40
Guidewire: Filter wire
Stent: Carotis Wallstent 7x30 mm
Balloon: Sterling 5x20 mm

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Ruzsa Z - AIMRADIAL 2013 - Carotid artery stenting

  • 1. Comparison of transradial and transfemoral approach for carotid artery stenting: RADCAR study (RADial access for CARotide artery stenting) Cardiology Center, Semmelweis University, Budapest, Hungary BĂĄcs-Kiskun County Hospital, KecskemĂ©t, Hungary Augusta Hospital, DĂŒsseldorf, Germany ZoltĂĄn Ruzsa, BalĂĄzs Nemes, LĂĄszlĂł PintĂ©r, BalĂĄzs Berta, KĂĄroly TĂłth, Barna Teleki, SĂĄndor Nardai, ZoltĂĄn Jambrik, György SzabĂł, Ralf Kolvenbach, KĂĄlmĂĄn HĂŒttl, BĂ©la Merkely AimRadial 2013 New York
  • 2. Disclosure Statement of Financial Interest I, ZoltĂĄn Ruzsa MD. PhD. DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
  • 3. Background Severe access 1 1. Yoo BS. Catheter Cardiovasc Interv. 2002 Jun;56(2):243-5. Cannulation problems 3,4 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.
  • 4. Background (Transradial CAS) Publication year Study Patient No Success (%) Cross over (%) Asympt RAO (n, %) Major vasc complication MACCE Pinter et al. 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 Bakoyiannis 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. 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 6 1. 2. 3. 4. 5. 6. 7. Pinter et al. J Vasc Surg. 2007 Jun;45(6):1136-41. Folmar J et al. Catheter Cardiovasc Interv. 2007 Feb 15;69(3):355-61. Patel et al. Catheter Cardiovasc Interv. 2010 Feb 1;75(2):268-75. Bakoyiannis C et al. Int Angiol. 2010 Feb;29(1):41-6. Mendiz OA. Vasc Endovascular Surg. 2011 Aug;45(6):499-503. Ruzsa et al. Cardiologia Hungarica. 2012; 42 : 6–X Etxegoien N. Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1081-7.
  • 5. 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).
  • 6. Right sided lesion Pulling back and rotating Aortography with 15 ml the Simmons catheter contrast 2. 1.
  • 7. Right sided lesion Selective angiography in AP and LAO90 view
  • 10. Left sided lesion Aortography with 15 ml contrast 2. 1. Selective angiography in AP and LAO90 view
  • 13. Demographic and clinical data of all study patients Radial group Femoral group P value (n=130) (n=130) Age 66.8±8.9 66.7±10.2 0.856 Male (%) 60.8 65.4 0.441 Hypertension (%) 77.7 88.5 0.021 Hyperlipidaemia (%) 56.2 47.7 0.172 Diabetes mellitus (%) 36.2 36.9 0.898 Obesity (%) 14.6 34.6 0.0003 Smoker (%) 28.5 26.9 0.889 Peripheral artery disease (%) 13.9 13.8 1.000 Coronary artery disease (%) 24.6 24.6 0.776 Positive family history (%) 6.9 9.2 0.495 Dialysis (%) 6.2 3.1 0.237
  • 14. Angiographic data Radial group Femoral group (n=117) p value (n=128) Aortic arch morphology Arch type I. n (%) 79 (67.5) 108 (84.4) 0.002 Arch type II-III n (%) 38 (32.5) 20 (15.6) 0.073 0.131 Stenosis localisation - Left sided n (%) 50 (42.7) 75 (58.6) - Right sided n (%) 67 (57.3) 53 (41.4) Reference diameter (ICA) (mm) 5.7±0.9 5.7±0.9 0.854 Stenosis diameter (%) 81.9 84.1 0.286
  • 15. Procedural data Successful puncture in all patients n (%) 128 (98.5) 130 (100.0) 0.156 Successful cannulation n (%) 119 (91.5) 129 (99.2) 0.003 Successful procedure from primary access n (%) 117 (90.0) 128 (98.5) 0.003 Cross over n (%) 10.0 1.5 0.003 Puncture time (sec) 30±48 25±19 0.347 Cannulation time (sec) 118±152 93±95 0.141 Procedure time (sec) 1744±742 1665±744 0.409 X Ray dose (mGy) 223±138 182±106 0.008 Fluoroscopy time (sec) 613±289 579±285 0.359 Contrast volume (ml) 117.9±39.3 110.1±36.3 0.111 Hospitalization days 1.17±0.40 1.25±0.45 0.006 Consumption of devices Diagnostic catheter / procedure (%) 122 (104.3) 110 (85.9) 0.011 Guide catheter / procedure (%) 108 (92.3) 77 (60.2) <0.001 Guiding sheath (%) 9 (7.7) 51 (39.8) <0.001 Buddy wire (%) 45 (38.5) 69 (53.9) 0.016 Balloon / procedure (%) 128 (109.4) 147 (114.8) 0.355 Stent used / procedure (%) 112 (95.7) 126 (98.4) 0.204
  • 16. MACCE (Major Adverse Cerebral and Cardiac Events) Radial group (n=117) Femoral group (n=128) p value MACCE n (%) 1 (0.9) 1 (0.8) 0.949 - Death 1 (0.9) 0 (0.0) 0.295 - Myocardial infarction 0 (0.0) 0 (0.0) 1.000 - Reintervention 0 (0.0) 0 (0.0) 1.000 - Stroke 1 (0.9) 1 (0.8) 0.949 Vascular complications Minor n (%) 9 (7.7) 6 (4.7) 0.327 - Spasm 0 (0.0) 0 (0.0) 1.000 - Haematoma 1 (0.9) 6 (4.7) 0.072 - Asymptomatic RAO 8 (6.8) 0 (0.0) 0.003 - Other 0 (0.0) 0 (0.0) 1.000 1 (0.9) 1 (0.8) 0.949 Major n (%) - Symptomatic RAO 1 (0.9) 0 (0.0) 0.295 - Bleeding and compartment syndrome 0 (0.0) 1 (0.8) 0.338 - Other 0 (0.0) 0 (0.0) 1.000 10 (8.6) 7 (5.5) 0.344 Total vascular complication n (%)
  • 17. Conclusion ‱ 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 ‱ In severe PAD, tortuose iliac artery and aortic arch abnormalities (Bovine arch, Arch II-III) the transradial angioplasty can be better than transfemoral angioplasty ‱ It can minimaize the potential embolisation from aortic arch ‱ Due to fast mobilisation the patient comfort is better
  • 19. Case 1.- Bovine arch direct cannulation Access: JR 7F Guiding: 7F JR3,5 Guidewire: Filter wire Stent: Carotis Wallstent 7x30 mm Balloon: Sterling 4x20 and 6x20 mm
  • 20. Case 2.-Loop technique Access: 7F Guiding: 7F XF40 Guidewire: Filter wire Stent: Carotis Wallstent 7x30 mm Balloon: Sterling 5x20 mm