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

Dr I...
Conflict of Interests

•

This study was supported with an un-restricted grant from Terumo® and
ATES Medical which was sole...
Study Background
•

Radial artery occlusion following trans-radial access is a well known
complication of the procedure li...
Study Background
•

Pathogenesis of RA occlusion is suggested to be due to locally organized
thrombus, which forms during ...
Study Background
PROPHET STUDY
Pancholy S et al 2008

Pancholy S et al 2009
J Invasive Cardiology
2009;21:101–104

Cathete...
Aims of Study
(1) To compare RA patency rates 30 days post trans-radial access between two
different commercially availabl...
Aims of Study
(2) To determine if the use of 2 different modern “patent haemostasis” techniques
has an effect on radial ar...
Aims of Study
(3) To achieve early band removal in all groups
(4) To assess adverse bleeding events, ischaemic hand events...
Modified TR Band MAP Device
Allows measurement of pressure in the TR band cuff
and matching to patients own mean arterial p...
Study	
  Design
Prospective

Patient consent and voluntary enrolment

Open labelled
Single high volume radial centre
Rando...
Study Inclusion and Exclusion
Inclusion Criteria
1. All consenting patients on cardiac wards and in the Cardiac Short Stay...
Study Population
Patients from Vancouver Island, British Columbia, Canada

7 hour drive

Royal Jubilee
Hospital
Study	
  Arm	
  1	
  -­‐	
  TR	
  Band	
  15mls	
  Standard	
  Protocol
Standard	
  TR	
  band	
  protocol	
  using	
  15m...
Study	
  Arm	
  2	
  -­‐	
  TR	
  Band	
  MAP	
  Guided	
  Protocol	
  
Patent	
  haemostasis	
  band	
  defla7on	
  protoc...
Study	
  Arm	
  3	
  -­‐	
  Bengal	
  Band	
  Protocol
Bengal	
  Band	
  protocol	
  with	
  the	
  band	
  applied	
  and...
Results
•
•
•
•
•
•

Recruitment commended December 2010

•

No deaths, no serious adverse events reported

Interim analys...
Results
Patient Demographics
TR-­‐15mls

TR-­‐MAP

Bengal	
  Band

Total	
  number	
  of	
  pa7ents	
  enrolled

237

245
...
Results
TR-­‐15mls
Total	
  dura7on	
  of	
  cannula7on	
  (mins) 40.2

TR-­‐MAP

Bengal	
  Band

P	
  value

37.1

38.6

...
Results
TR-­‐15mls

TR-­‐MAP

Bengal	
  Band

P	
  value

Bivalirudin	
  %	
  (n)

7.4	
  (16)

7.4	
  (16)

7.5	
  (16)

...
Results
TR-­‐15mls

TR-­‐MAP

Bengal	
  Band

P	
  value

TIME	
  TO	
  RECOVERY	
  ARRIVAL

11.2

11.5

11.4

0.1

TIME	
...
Results
Time of Band Placement
0 mins

Systolic BP
Diastolic BP
MAP

TR-­‐15mls TR-­‐MAP Bengal	
  Band P	
  value
138.0
1...
Results
TR-­‐15mls
Haematoma	
  present	
  -­‐	
  	
  (Yes)

TR-­‐MAP

Bengal	
  Band

13.8%	
  (30/217) 14.8%	
  (32/216)...
Results
TR-­‐15mls

TR-­‐MAP

Bengal	
  Band

P	
  value

%	
  of	
  pa7ents	
  who	
  completed	
  the	
  ques7onnaire

9...
Results
30 Day Patency Rates
TR-­‐15mls

TR-­‐MAP Bengal	
  Band

P	
  value

34.0

36.0

33.0

NS

Negative signal

1/217...
Conclusions
•

Following trans radial vascular access 30 day RA patency rates can be
maintained at >99% with modern more e...
Acknowledgements

•

Nursing staff at the Royal Jubilee Hospital

•

Research Staff at the Victoria Heart Institute
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Nadra I - AIMRADIAL 2013 - PROTECT-ARMS trial

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

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Nadra I - AIMRADIAL 2013 - PROTECT-ARMS trial

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 12. Study Population Patients from Vancouver Island, British Columbia, Canada 7 hour drive Royal Jubilee Hospital
  13. 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. 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) 9%5)#:1-;% 6)5-% 7)#-% =%5)#:1-;% !"#$%&#% '(()*"+%)#%,-.&*-(/%% !"#$%&'()*+)(,-&').')/,%&),0%) 1,2#$2,(&)34+) K&%"8&),.0)B0"%)NK)@,';)("),#?.&8&) 34+)A0&//$0&) !"#$%&'()0&8&0/&)422,'O/)N&/() ):,027)*2&&;.'<) >&/) =") <=%5)#:1-;% 01"(1%!"#$%2-3"4&#% 52"627)0&%"8&),.0)&8&07)9)%.'$(&/) H,(&)*2&&;.'<) >&/) =") 89%5)#:1-;% 6,%!"#$%% ?'>%@:)$-$%>(&1&.&+% % Systolic BP ! diastolic BP % MAP = + diastolic BP 3 % 9)%.'$(&/) 4;;),.0),#?.&8.'<)@,';) A0&//$0&)"B)CD%%E<)"8&0) /7/("2.#)*+)B"0)9)%.'$(&/) F.B)#"'#&0'&;)#,22)!"#("0G) JD)%.'$(&/) 4;;),.0),#?.&8.'<)@,';) A0&//$0&)"B)CD%%E<)"8&0) /7/("2.#)*+)B"0)JD)%.'$(&/) F.B)#"'#&0'&;)#,22)!"#("0G) ,-5&*-%!"#$% I&07)H,(&)*2&&;.'<) =") 2(-;;%>:#.1:(-%0)1-% >&/) K&L,AA27)@,';)$/.'<)C9%2/) "B),.0)"0)$'M2)?,&%"/(,/./) ./),#?.&8&;),';)#,22);"#("0)
  15. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 26. Acknowledgements • Nursing staff at the Royal Jubilee Hospital • Research Staff at the Victoria Heart Institute

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