Preventing Radial Occlusion Through more Effective Closure Therapy and Advanced Radial Management Study

1. PROTECT ARMS
Preventing Radial Occlusion Through more Effective Closure Therapy and
Advanced Radial Management Study
Dr Imad Nadra
BSc.MBChB.MRCP(UK).PhD
Principle Investigator
On Behalf of the Protect Arms Investigators
Anthony Della Siega, Simon D. Robinson
Peter Klinke, Tycho Vuurmans, Ashley Mattson, Robert D.Kinloch
Jehangir Din, Amir Ayobi, Alex Sirker, Eric .Fretz, Richard Mildenberger
!
AIM Radial 2013
Late Breaking Clinical Trials

2. Conflict of Interests
•
This study was supported with an un-restricted grant from Terumo® and
ATES Medical which was solely used for reimbursement of patients travel
expenses to facilitate 30 day follow up
•
Writing of the study protocol, all data collection and results analysis was
carried out independent of study sponsors

3. Study Background
•
Radial artery occlusion following trans-radial access is a well known
complication of the procedure limiting
•
•
•
•
•
•
Future trans-radial access
Bypass conduit harvesting
Renal dialysis fistulae formation
Plus the theoretical concern of hand ischaemia and
Leading to reduced patient confidence in the procedure
Reported incidence historically is between 5-12%

4. Study Background
•
Pathogenesis of RA occlusion is suggested to be due to locally organized
thrombus, which forms during the process of achieving vessel haemostasis
through the application of manual pressure over the artery
•
Most radial operators now prefer commercially available pressure devices
that have been specifically designed for trans-radial access procedures
•
Despite their successful clinical application for achieving haemostasis and
reducing bleeding complications very little attention has been paid to their
effect on long term vessel patency
•
Currently there is no gold standard device, technique or published
international guidelines aimed to help protect against RA occlusion
•
Furthermore, the effects of excessive compression exerted by the current
commercially available haemostatic devices versus newer emerging devices,
has not been fully investigated

5. Study Background
PROPHET STUDY
Pancholy S et al 2008
Pancholy S et al 2009
J Invasive Cardiology
2009;21:101–104
Catheterisation and Cardiovascular
Interventions 2008, 72:335-340
Total number of
patients
n=436
RACOMAP STUDY
Cubero JM et al 2009
Catheterization and Cardiovascular
Intervnetions 2009, 73:467-472
n=500
n=351
Device Used
Hemoband
n=219
Hemoband
n=217
Hemoband
n=250
TR Band
n=250
TR Band
n=176
TR Band
n=175
Haemostasis method
Conventional
pressure
haemostasis
Barbeau s test to
document RA
patency during
Pressure, Patent
haemostasis
Conventional
Pressure
Haemostasis
15mls air inflation
MAP guided
compression
15mls air inflation
RA Occlusion
Early (24-72 hrs)
12%
(n=27)
5%
(n=11)
RRR 59% p<0.05
11.2%
(n=28)
4.4%
(n=11)
RRR 60.7% P<0.003
1.1%
(n=2)
12%
(n=21) p=0.0001
RA Occlusion
Late (30 days)
7%
(n=16)
1.8%
(n=4)
RRR 75% p<0.05
7.2%
(n=18)
3.2%
(n=8)
RRR 55.6% p<0.04

6. Aims of Study
(1) To compare RA patency rates 30 days post trans-radial access between two
different commercially available haemostasis devices
TR band™ by Terumo®
!
Bengal Band™ by Group ATES Medical
!

7. Aims of Study
(2) To determine if the use of 2 different modern “patent haemostasis” techniques
has an effect on radial artery patency at 30 days
a. Patent haemostasis using reverse plethysmography
b. Patent haemostais achieved through patient MAP guided pressure application
c. Versus the standard occlusive hold currently used for compressive haemostasis
!
!
!
!

8. Aims of Study
(3) To achieve early band removal in all groups
(4) To assess adverse bleeding events, ischaemic hand events
(5) To assess patient comfort between the different devices & haemostasis techniques

9. Modified TR Band MAP Device
Allows measurement of pressure in the TR band cuff
and matching to patients own mean arterial pressure
!
Cubero JM et al.
Catheterization and
Cardiovascular
Intervnetions 2009,
73:467-472

10. Study
Design
Prospective
Patient consent and voluntary enrolment
Open labelled
Single high volume radial centre
Randomized controlled
Post trans-radial cardiac catheterisation
-
-Time of Sheath Removal900 Patients randomly assigned to one of 3 treatment groups
Comparative study
TR Band™
TR Band™
Bengal Band™
300 Patients
300 patients
300 Patients
1. TR Band™
15mls Air Inflation
(Current Practice)
2. TR Band™
3. Bengal Band™
MAP guided Air Plethysmography guided
Inflation
pressure application
45 minutes
Commencement of band loosening
60 minutes
Band Removal
(Wound Dressing)
Note: 30 day follow up investigators
were blinded to initial treatment group
30 (+/-7) days
Doppler Follow Up of radial artery
Primary Endpoint
30 day Radial Patency Rate
Secondary Endpoints
Access site bleeding/complications
Comfort
Time to succesful band removal

11. Study Inclusion and Exclusion
Inclusion Criteria
1. All consenting patients on cardiac wards and in the Cardiac Short Stay of
the Royal Jubilee Hospital in Victoria, BC who are undergoing coronary
angiography or PCI and have at minimum one initially patent radial artery
Exclusion Criteria
1. Contraindications to a trans-radial access approach including a failed Allen’s
test using plethysmography, intended haemodialysis or the presence of a
current AV fistulae.
2. Patients unable to attend for a 30 (±7) day follow up
3. Patients unable to legally or competently consent for themselves (Presedated patients excluded)
4. Unsuccessful attempt to cannulate the radial artery

12. Study Population
Patients from Vancouver Island, British Columbia, Canada
7 hour drive
Royal Jubilee
Hospital

13. Study
Arm
1
-­‐
TR
Band
15mls
Standard
Protocol
Standard
TR
band
protocol
using
15mls
infla7on
volume
aimed
to
achieve
haemostasis
without
regard
for
vessel
patency
during
haemostsis
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14. Study
Arm
2
-­‐
TR
Band
MAP
Guided
Protocol
Patent
haemostasis
band
defla7on
protocol
aimed
to
match
band
infla7on
pressure
to
the
pa7ents
own
mean
arterial
pressure
(MAP)
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15. Study
Arm
3
-­‐
Bengal
Band
Protocol
Bengal
Band
protocol
with
the
band
applied
and
then
loosened
using
reverse
plethysmography
aiming
to
achieve
patent
haemostasis
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16. Results
•
•
•
•
•
•
Recruitment commended December 2010
•
No deaths, no serious adverse events reported
Interim analysis with study end December 2012
Total number of patients enrolled 724
Total number of patients completing 30 day follow up was 646 (89%)
Total patients excluded from analysis 78 (11%)
Drop out almost exclusively due to patients not wishing to travel back to
Victoria.

17. Results
Patient Demographics
TR-­‐15mls
TR-­‐MAP
Bengal
Band
Total
number
of
pa7ents
enrolled
237
245
242
No.s
per
group
comple7ng
30
day
Follow
up
92%
(n=217)
88%
(n=216) 88%
(n=213)
Age
(years)
66.9
66.6
67.1
Male
%
71%
81%
78%
Height
(cm)
172.5
174.0
173.1
Weight
84.3
86.9
86.8
BMI
28.3
28.7
29.0
Current
Smoking
9.2
(20)
7.4
(16)
10.8
(23)
Diabetes
21.7
(47)
23.1
(50)
19.7
(42)
Previous
trans-­‐radial
interven7on
22.1
(48)
22.2
(48)
25.1
(53)
Pre
procedure
posi7ve
Allen’s
test
99.5
(216)
99.5
(215)
99.5
(211)

18. Results
TR-­‐15mls
Total
dura7on
of
cannula7on
(mins) 40.2
TR-­‐MAP
Bengal
Band
P
value
37.1
38.6
NS
Sheath
size
%
(n)
5F
8.3% (18)
10.2% (22) 8% (17)
NS
6F
91.7%
(199)
89.8%
(194)
92%
(196)
NS
5F
37.85
(82)
35.2
(76)
35.2
(75)
NS
6F
62.25
(135)
64.8
(140)
64.8
(138)
NS
Complex
Radial
Anatomy
%
(n)
4.1
(9)
3.2
(7)
2.8
(6)
NS
Spasm
%
(n)
2.8%
(6)
3.2
(7)
3.8
(8)
NS
Catheter
size
%
(n)

19. Results
TR-­‐15mls
TR-­‐MAP
Bengal
Band
P
value
Bivalirudin
%
(n)
7.4
(16)
7.4
(16)
7.5
(16)
NS
GPIIb/IIIa
%
(n)
1.8
(4)
3.7
(8)
2.3
(5)
NS
Heparin
Dose
iu
(total
for
en7re
case) 5906.0
5542.0
5657.0
NS
Ranges
of
Heparin
Given
0-­‐16000
0-­‐16000
0-­‐11000
NS
Aspirin
%
(n)
97.7
(212)
95.4
(206) 96.2
(205)
NS
Clopidogrel
%
(n)
92.6
(201)
85.2
(184) 90.1
(192)
NS
Prasugrel
%
(n)
0
(0)
0.9
(2)
0.5
(1)
NS
Ticlopidine
%
(n)
0
(0)
0.5
(1)
0
(0)
NS
Ticagrelor
%
(n)
0
(0)
0
(0)
0
(0)
NS
Warfarin
%
(n)
2.8
(6)
1.4
(3)
1.9
(4)
NS

20. Results
TR-­‐15mls
TR-­‐MAP
Bengal
Band
P
value
TIME
TO
RECOVERY
ARRIVAL
11.2
11.5
11.4
0.1
TIME
TO
BAND
LOOSENING
56.5
58.7
57.4
0.3
Range
33-­‐125
27-­‐179
24-­‐183
TIME
TO
BAND
REMOVAL
99.3
86.2
81.4
56
to
270
8
to
205
50
to
206
Range
<0.001

21. Results
Time of Band Placement
0 mins
Systolic BP
Diastolic BP
MAP
TR-­‐15mls TR-­‐MAP Bengal
Band P
value
138.0
137
134.0
NS
74
74.0
93
95.0
Time of Initial Band Loosening Systolic BP
5 mins
Diastolic BP
MAP
138.0
139.0
71.0
69
92
Time of Final Band Loosening
45 mins
Systolic BP
Diastolic BP
MAP
129.0
129.0
69.0
128
Time of Band Removal
60 mins
Systolic BP
Diastolic BP
MAP
128.0
127.0
69.0
68
135.0
NS
126.0
NS
125.0
NS

22. Results
TR-­‐15mls
Haematoma
present
-­‐
(Yes)
TR-­‐MAP
Bengal
Band
13.8%
(30/217) 14.8%
(32/216) 7%
(15/213)
P
value
0.02
Interven7on
to
stop
bleeding?
(Y/N) 7.4%
(16/217)
7.9%
(17/216)
6.1%
(13/213)
NS
Haematoma
greater
than
5cm
(Yes)
3.2%
(7/216)
1.4%
(3/213)
0.15
Surigcal
interven7on
to
stop
bleeding 0%
0%
0%
NS
%
needing
blood
transfusion
0%
0%
0%
NS
Pseudoaneurysm
found
<
30
days
1%
(2/217)
0.55
(1/216)
0.5%
(1/213)
NS
4.6%
(10/217)

23. Results
TR-­‐15mls
TR-­‐MAP
Bengal
Band
P
value
%
of
pa7ents
who
completed
the
ques7onnaire
95.4% (207)
96.2% (210)
98.1% (209)
NS
Band
allowed
pa7ent
to
to
easily
move
wrist?
Yes
70.5% (153)
75% (162)
72.3% (154)
NS
Band
limited
the
ability
to
perform
rou7ne
tasks?
Yes
24% (52)
23.6% (51)
27.2% (58)
NS
14.3% (31)
14.8% (32)
21.6% (46)
0.06
Mild
4.1% (9)
6% (13)
6.6% (14)
NS
Moderate
8.3% (18)
8.3% (18)
14.1% (30)
> 0.05
Severe
1.8% (4)
1% (2)
1% (2)
NS
Significant
pain
was
experience
in
the
hand
(Y/N)
11.1% (24)
8.8% (19)
8.9% (19)
NS
Mild
7.4% (16)
6% (13)
2.8% (6)
NS
3.2 (7)
2.3% (5)
5.6% (12)
NS
0.5% (1)
1% (2)
0% (0)
Significant
pain
experienced
at
pressure
site
(wrist)?
(YES)
Moderate
Severe

24. Results
30 Day Patency Rates
TR-­‐15mls
TR-­‐MAP Bengal
Band
P
value
34.0
36.0
33.0
NS
Negative signal
1/217
1/216
1/213
30 day Patency rates (%)
99.5%
99.5%
99.5%
Negative signal
2/217
2/216
1/213
30 day Patency rates (%)
99%
99%
99.5%
Average time of follow up (days)
Bi-directional doppler
NS
Reverse Allen’s test
NS

25. Conclusions
•
Following trans radial vascular access 30 day RA patency rates can be
maintained at >99% with modern more effective haemostasis management
•
No difference in RA occlusion was observed between the 3 arms using
standard pressure management or patent haemostasis and using either the
TR band or Bengal band
•
There appeared to be an increase in minor but not major bleeding leading to
small haematoma formation between the TR band as compared to the
Bengal Band
•
No difference in vascular injury of access site complications were noted
between the 3 groups with
•
A moderate increase in discomfort at the pressure site was experienced by
patients with the Bengal band in comparison to the TR band
•
Early band removal is feasible at <90 minutes when a patent haemostasis
technique is adopted irrespective of which band was used

26. Acknowledgements
•
Nursing staff at the Royal Jubilee Hospital
•
Research Staff at the Victoria Heart Institute