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Anticoagulation Strategies for
 Transradial Diagnostic and
    Interventional Cases

     Tift Mann, MD, FACC
Disclosure Statement of Financial Interest


I, Tift Mann, 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.
Heparin must be administered for all
                             transradial procedures

                        100
2mo radial occlusion




                         80
                                71%

                         60

                         40
                                              24%
                         20
                                                                 4%
                          0
                              No Heparin   UFH 2000-3000      UFH 5000

                                                 Spaulding et al CCVD 39:365 (1996)
Bernat et al, AJC 2011
IA vs IV heparin:

No difference in incidence of RAO




              Pancholy. Am J Cardiol 2009; 104: 1083
Bivalirudin vs heparin:

No difference in RAO




               Plante et al. CCVI 2010; 76:654
What anticoagulation strategy should be
          used for ad hoc TRI?


  1. Increase the total heparin dose
       to 80-100 units/kg

  2. Switch to bivalirudin
Transitioning to bivalirudin in ad hoc
         transradial procedures:
         divide the heparin dose

‱ Divided dosing with unfractionated heparin
  should provide the same protection against post-
  procedure radial occlusion as the standard 5000
  unit single dose if diagnostic only procedure .

‱ The safety profile of bivalirudin should not be
  altered if it is given after an initial reduced
  heparin dose should PCI be required.
Transitioning to bivalirudin in ad hoc
        transradial procedures




                     Venkatesh K et al. JIC 2006;18:120
Does TRI and Bivalirudin combination
               reduce
   all procedure-related bleeding?
Site of Bleeding Complications in Patients
             Undergoing PCI




                       Rao, et al. J Am Coll Cardiol 2010;55:2187-2195
R
I
V
A
L

             Site of Non-CABG Major Bleeds
                     (RIVAL definition)




      *Sites of Non Access site Bleed: Gastrointestinal (most common site), ICH,
      Pericardial Tamponade and Other
Eurovision: Bivalirudin monotherapy in PCI

                    Bleeding Outcomes
                            Femoral     Radial   P-value
                           (n=1353)    (n=580)
   Major Bleeding           1.7%        1.2%     0.4216
   Minor Bleeding           4.8%        1.9%     0.0026
   Thrombocytopenia           0          0
   Any bleeding             8.0%        4.5%     0.0055
   Access Site Bleed        3.6%        1.0%     0.0017
   Non-Access Site Bleed    1.6%         0.9     0.1897




                             Hamon et al, TCT 2011
EArly Discharge After Transradial
 Stenting of CoronarY Arteries in
High–Bleeding-Risk Patients Using
 Bivalirudin to Reduce Bleeding
        EASY-B2B Study


    Pts with increased bleeding risk
   undergoing TR PCI randomized to
         Heparin vs Bivalirudin
                           Bertrand et al
R
I
V
A
L



            Definition: Major Bleeding
             ïź   Fatal

             ïź    > 2 units of Blood transfusion

             ïź   Hypotension requiring inotropes

             ïź   Requiring surgical intervention

             ïź    ICH or Intraocular bleeding leading to
                 significant vision loss
R
I
V
A
L


   Definition: Major Vascular Access Site
                 Complications

            ‱Large hematoma

            ‱ Pseudoaneurysm requiring closure

            ‱ AV fistula

            ‱ Other vascular surgery related to the access site

            ‱ Blood txf 1 unit
R
I
V
A
L

                  “Other” Outcomes

                  Radial Femoral
                  (n=3507)   (n=3514)   HR    95% CI     P
                    %          %
Major Vascular
Access Site        1.4        3.7       0.37 0.27-0.52 <0.0001
Complications

ACUITY Non-CABG
                   1.9        4.5       0.43 0.32-0.57 <0.0001
Major Bleeding
R
I
V
A
L
                         Results stratified by
            High*, Medium* and Low* Volume Radial Centres
                *High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≀60)

Tertiles of Radial PCI Centre Volume/yr                       HR (95% CI)                     p-value
      Primary Outcome                                                                        Interaction
            High                                                                                0.021
            Medium
            Low
      Death, MI or stroke
            High                                                                                0.013
            Medium
            Low
      Non CABG Major Bleed
            High
            Medium                                                                              0.538
            Low
     Major Vascular Complications
            High                                                                                0.019
            Medium
            Low
     Access site Cross-over
             High                                                                               0.003
             Medium
             Low
                                                   0.25           1.00           4.00       16.00
                                                     Radial better        Femoral better
Risk
of
death
for
up
to
1
year:
transfemoral

vs.
transradial
access
site


                              Adjusted OR (95% CI)
                               0.78 (0.64-0.96)
                                P= 0.018




                    From SCAAR registry, EuroPCR, 2011
What is the strategy for patients on
coumadin undergoing TR procedures?
Transradial access in the fully
   anticoagulated patient
                              N=66

                             No major bleeding




              Hildick-Smith et al CCVI 58:8,2003
TR Access in pts receiving coumadin


                   INR 2.4           INR 1.4




               Sanmartin et al. Rev Esp Cardiol. 2007;60:988
CONCLUSION:

 Transradial access provides a
safety margin for interventional
          procedures
Radial vs. Femoral Access
MAJOR BLEEDING       DEATH / MI / STROKE




                        Jolly et al. Am Heart J 2009
Abciximab in pts with transradial access




              N=504             N=501

                      Bertrand et al. Circ 2006;114:2636
Risk
of
death
for
up
to
30
days:
transradial
vs.
transfemoral
access
site
(male
vs.
female)




                   Favors
Radial









Favors
Femoral


                                                                  OR 95% CI

                                                            0.66 (0.51-0.86), p=0.002




                                                            0.78 (0.64-0.97), p=0.022
Risk
of
death
for
up
to
30
days:
transradial
vs.
transfemoral
access
site
(by
age)


            Favors
Radial









Favors
Femoral


                                                      OR 95% CI

                                                     0.59 [ 0.45-0.78]


                                                     0.70 [0.53-0.93]



                                                     1.12 [0.78- 1.61]


                                                     0.84 [0.50-1.42]
Results
                          Outcome


                                      Transfemoral        Transradial        P value        OR            Adjusted OR
                                          (%)                (%)                         (95 % CI)        (95 % CI)
N = 21 339




Measured Variable:
30 day mortality event/N (%)        667/15290   (4.4)    193/6049    (3.2)   <0.001    0.72 (0.61-0.85) 0.57 (0.46-0.72)
1 year mortality event/N (%)        982/13446   (7.3)    260/4175    (6.2)    0.018    0.84 (0.73-0.97) 0.78 (0.64-0.96)

Male: 30 day mortality/N (%)         120/4396   (2.7)    373/10797   (3.5)   0.022     0.78 (0.64-0.97)

Female: 30 day mortality/N(%)        73/1653    (4.4)    294/4493    (6.5)   0.002     0.66 (0.51-0.86)
Any reported bleeding event/N(%)    495/14953   (3.3)    88/5866     (1.5)   <0.001    0.45 (0.35-0.56) 0.43 (0.31-0.61)


Serious bleeding event/N (%)        335/14953   ( 2.2)   58/5866     (1.0)   <0.001    0.44 (0.33-0.58) 0.43 (0.32-0.57)
Hospital stay Days mean(SD)           5.2       (6.3)      4.8       (5.1)   <0.001




                                                From SCAAR registry, EuroPCR, 2011
Anticoagulation Strategies for
 Transradial Diagnostic and
    Interventional Cases

       Tift Mann, MD, FACC
             TCT 2011

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Mann T 201111

  • 1. Anticoagulation Strategies for Transradial Diagnostic and Interventional Cases Tift Mann, MD, FACC
  • 2. Disclosure Statement of Financial Interest I, Tift Mann, 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. Heparin must be administered for all transradial procedures 100 2mo radial occlusion 80 71% 60 40 24% 20 4% 0 No Heparin UFH 2000-3000 UFH 5000 Spaulding et al CCVD 39:365 (1996)
  • 4. Bernat et al, AJC 2011
  • 5. IA vs IV heparin: No difference in incidence of RAO Pancholy. Am J Cardiol 2009; 104: 1083
  • 6. Bivalirudin vs heparin: No difference in RAO Plante et al. CCVI 2010; 76:654
  • 7. What anticoagulation strategy should be used for ad hoc TRI? 1. Increase the total heparin dose to 80-100 units/kg 2. Switch to bivalirudin
  • 8. Transitioning to bivalirudin in ad hoc transradial procedures: divide the heparin dose ‱ Divided dosing with unfractionated heparin should provide the same protection against post- procedure radial occlusion as the standard 5000 unit single dose if diagnostic only procedure . ‱ The safety profile of bivalirudin should not be altered if it is given after an initial reduced heparin dose should PCI be required.
  • 9. Transitioning to bivalirudin in ad hoc transradial procedures Venkatesh K et al. JIC 2006;18:120
  • 10.
  • 11.
  • 12.
  • 13. Does TRI and Bivalirudin combination reduce all procedure-related bleeding?
  • 14. Site of Bleeding Complications in Patients Undergoing PCI Rao, et al. J Am Coll Cardiol 2010;55:2187-2195
  • 15. R
I
V
A
L Site of Non-CABG Major Bleeds (RIVAL definition) *Sites of Non Access site Bleed: Gastrointestinal (most common site), ICH, Pericardial Tamponade and Other
  • 16. Eurovision: Bivalirudin monotherapy in PCI Bleeding Outcomes Femoral Radial P-value (n=1353) (n=580) Major Bleeding 1.7% 1.2% 0.4216 Minor Bleeding 4.8% 1.9% 0.0026 Thrombocytopenia 0 0 Any bleeding 8.0% 4.5% 0.0055 Access Site Bleed 3.6% 1.0% 0.0017 Non-Access Site Bleed 1.6% 0.9 0.1897 Hamon et al, TCT 2011
  • 17. EArly Discharge After Transradial Stenting of CoronarY Arteries in High–Bleeding-Risk Patients Using Bivalirudin to Reduce Bleeding EASY-B2B Study Pts with increased bleeding risk undergoing TR PCI randomized to Heparin vs Bivalirudin Bertrand et al
  • 18. R
I
V
A
L Definition: Major Bleeding ïź Fatal ïź > 2 units of Blood transfusion ïź Hypotension requiring inotropes ïź Requiring surgical intervention ïź ICH or Intraocular bleeding leading to significant vision loss
  • 19. R
I
V
A
L Definition: Major Vascular Access Site Complications ‱Large hematoma ‱ Pseudoaneurysm requiring closure ‱ AV fistula ‱ Other vascular surgery related to the access site ‱ Blood txf 1 unit
  • 20. R
I
V
A
L “Other” Outcomes Radial Femoral (n=3507) (n=3514) HR 95% CI P % % Major Vascular Access Site 1.4 3.7 0.37 0.27-0.52 <0.0001 Complications ACUITY Non-CABG 1.9 4.5 0.43 0.32-0.57 <0.0001 Major Bleeding
  • 21. R
I
V
A
L Results stratified by High*, Medium* and Low* Volume Radial Centres *High (>146 radial PCI/year/ median operator at centre), Medium (61-146), Low (≀60) Tertiles of Radial PCI Centre Volume/yr HR (95% CI) p-value Primary Outcome Interaction High 0.021 Medium Low Death, MI or stroke High 0.013 Medium Low Non CABG Major Bleed High Medium 0.538 Low Major Vascular Complications High 0.019 Medium Low Access site Cross-over High 0.003 Medium Low 0.25 1.00 4.00 16.00 Radial better Femoral better
  • 23. What is the strategy for patients on coumadin undergoing TR procedures?
  • 24. Transradial access in the fully anticoagulated patient N=66 No major bleeding Hildick-Smith et al CCVI 58:8,2003
  • 25. TR Access in pts receiving coumadin INR 2.4 INR 1.4 Sanmartin et al. Rev Esp Cardiol. 2007;60:988
  • 26. CONCLUSION: Transradial access provides a safety margin for interventional procedures
  • 27. Radial vs. Femoral Access MAJOR BLEEDING DEATH / MI / STROKE Jolly et al. Am Heart J 2009
  • 28. Abciximab in pts with transradial access N=504 N=501 Bertrand et al. Circ 2006;114:2636
  • 29. Risk
of
death
for
up
to
30
days: transradial
vs.
transfemoral
access
site
(male
vs.
female) Favors
Radial









Favors
Femoral
 OR 95% CI 0.66 (0.51-0.86), p=0.002 0.78 (0.64-0.97), p=0.022
  • 30. Risk
of
death
for
up
to
30
days: transradial
vs.
transfemoral
access
site
(by
age) Favors
Radial









Favors
Femoral
 OR 95% CI 0.59 [ 0.45-0.78] 0.70 [0.53-0.93] 1.12 [0.78- 1.61] 0.84 [0.50-1.42]
  • 31. Results Outcome Transfemoral Transradial P value OR Adjusted OR (%) (%) (95 % CI) (95 % CI) N = 21 339 Measured Variable: 30 day mortality event/N (%) 667/15290 (4.4) 193/6049 (3.2) <0.001 0.72 (0.61-0.85) 0.57 (0.46-0.72) 1 year mortality event/N (%) 982/13446 (7.3) 260/4175 (6.2) 0.018 0.84 (0.73-0.97) 0.78 (0.64-0.96) Male: 30 day mortality/N (%) 120/4396 (2.7) 373/10797 (3.5) 0.022 0.78 (0.64-0.97) Female: 30 day mortality/N(%) 73/1653 (4.4) 294/4493 (6.5) 0.002 0.66 (0.51-0.86) Any reported bleeding event/N(%) 495/14953 (3.3) 88/5866 (1.5) <0.001 0.45 (0.35-0.56) 0.43 (0.31-0.61) Serious bleeding event/N (%) 335/14953 ( 2.2) 58/5866 (1.0) <0.001 0.44 (0.33-0.58) 0.43 (0.32-0.57) Hospital stay Days mean(SD) 5.2 (6.3) 4.8 (5.1) <0.001 From SCAAR registry, EuroPCR, 2011
  • 32. Anticoagulation Strategies for Transradial Diagnostic and Interventional Cases Tift Mann, MD, FACC TCT 2011