Bivalirudin or Heparin for Prevention of Radial Artery Occlusion in ad hoc Transradial PCI

1. Bivalirudin or Heparin
for Prevention of Radial Artery
Occlusion in ad hoc Transradial PCI
Experience at SRHC .
Sylvain Plante MD
PCI Program
Southlake Regional Health Centre
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2. Background
• Diagnostic cath lab since 1999
• First PCI at SRHC in November 2003
• Early adoption of bivalirudin as routine drug for PCI
• Publication of REPLACE-2 trial
• Validated as a safe and cost-effective alternative to heparin and routine
GP IIb/IIIa inhibition
• Procedural simplicity
• Experience with bivalirudin (site investigator in U.S.)
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3. Background
• Challenges of new PCI lab
• Temporary location – limited number of beds in recovery area
• Repatriation issues
• Short half-life (early femoral sheath removal)
• Radial access not routinely used
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4. Radial Artery Thrombosis
• Radial artery more prone to vasospasm following canulation
than the femoral artery, which significantly increase the risk of
permanent radial artery thrombosis.
• RAO rarely associated with significant clinical symptoms, but
may limit future access if other invasive procedures are
needed.
• To minimize the occurrence of painful spasm and the risk of
thrombosis, anti-spastic agents (verapamil, nitroglycerin) and
anticoagulant agents (heparin) are routinely administered
immediately following canulation of the radial artery.
• These simple measures have been very effective in reducing
the rate of late radial artery thrombosis to < 5%.
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5. Bivalirudin and Radial Access - SRHC
• Not an issue for elective PCI - Concerns about ad hoc PCI
• SRHC Protocol:
• Intra-arterial verapamil administered after RA canulation
• Coronary angiography
• IV heparin or bivalirudin administration delayed until angiography is
completed (10-15 min) and a decision made to proceed or not with PCI,
based on the suitability of the coronary anatomy.
• For patients not considered for ad hoc PCI, a bolus of IV heparin (70 U/
kg) is administered, the radial sheath is pulled out and hemostasis is
achieved with the compressive bracelet.
• For patients undergoing PCI, the IV bolus of bivalirudin is administered
and followed by infusion. Depending on the procedure duration,
bivalirudin infusion can be either discontinued or continued until the end,
at the interventionalistʼs discretion.
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6. Bivalirudin and Radial Access - SRHC
• This protocol has been associated with good clinical
outcomes with no apparent adverse events relating to radial
artery thrombosis.
• However, we felt it was important to document in a formal
manner the actual radial artery thrombosis rate to ensure that
it is not different from historical controls.
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7. SRHC Study
• Determine whether the SRHC protocol for radial artery
access results in acceptable radial artery thrombosis rates.
• Evaluate 400 consecutive patients who have undergone
coronary angiography +/- PCI using a radial access.
• Demonstrate that the rate of late radial artery thrombosis
using our modified approach to anticoagulation was within
normal range.
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8. Inclusion Criteria
• Angiography +/- PCI via the radial access.
• On ASA at the time of the procedure.
• On clopidogrel at the time of the procedure.
• IV heparin was discontinued > 6h or last dose of LMWH >12h
prior to the procedure.
• Informed consent obtained.
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9. Exclusion Criteria
• Acute STEMI (primary PCI)
• Shock
• Allergy to ASA or clopidogrel
• Unable to come to follow-up visit
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10. Methods
• Group 1 (n = 200); patients who underwent angiography and
PCI and who received IV bivalirudin.
• Group 2 (n = 200); patients who underwent angiography
alone and who received IV heparin (controls).
• Follow-up at 4-6 weeks
• RA thrombosis defined by 2 different criteria:
• absent waveform (Type D) on reverse Allen test using pulse oxymetry +
• absent Doppler flow
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11. Study Design
Study Design
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12. Baseline Data
Baseline Data
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13. Procedural Data
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14. RAO at Follow-up
RAO at Follow-up
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15. RAOat Follow-up
RAO
at Follow-up
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16. Patients with RAO
Patients with RAO
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17. Independent Predictors for RAO
Independent Predictors of RAO
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18. Discussion
• In our experience, delayed administration of heparin or
bivalirudin for transradial angiography followed by PCI is safe
and results in low radial artery occlusion rates.
• Although not statistically significant as per our definition,
delayed administration of IV heparin may result in RAO rates
slightly above historical controls.
• Administration route (IV vs IA) ?
• Need for heparin immediately after canulation ?
• Administration after sheath removal / placement of bracelet ?
• Type of bracelet ?
• Hydrophylic sheath ?
• Selection bias ?
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19. References
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20. References
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21. References
Ad hoc Transradial PCI - Bivalirudin
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22. Ad Hoc Transradial PCI - Bivalirudin
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23. Ad Hoc TransradialPCI - -Bivalirudin
Ad hoc Transradial PCI Bivalirudin
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24. Ad Hoc Transradial PCI - -Bivalirudin
Ad hoc Transradial PCI Bivalirudin
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