Ulnar artery intervention non inferior to radial approach: Reality or myth? AJmer

ULnar ARtery working group study.A randomized parallel group Non-Inferiority trial

Rajendra Gokhroo, MD,DM,FACCKamal Kishor, Bhanwar Ranwa, Devendra Bisht,

Sajal Gupta, A Avinash

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Disclosures

Nothing to disclose by any author.

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Background

• Worldwide radial artery cannulation has been accepted as a default technique for coronary access because of obvious safety advantages over femoral access.

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Limitations of Radial Access

– Frequent vasospasm, – More anatomical variation, – Small caliber and– Unsuitability of radial artery to be used as graft for

CABG after cannulation.

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• Can Ulnar artery be a viable alternative to radial artery for coronary access ?

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Scenario Till Date.. Trans ulnar access is inferior to Trans radial

Events(%)– MACE: 2.8 vs 3.4 P value<0.0001– Large hematoma: 3.2 vs 0.5 P value=0.03 (crossed non-inferiority)

– Spasm: 12.7 vs 16.9 P value=0.4– Vagal Reaction: 2.6 vs 2.3 P value=0.0002– Arterial Occlusion: 10.4 vs 8.9 P value=0.47– Crossover: 32.3 vs 5.9 P Value=0.004 (crossed non-inferiority)

The AURA of ARTEMIS Study .Circ Cardiovasc Interv.2013;6:252-261

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Scenario Till Date..

Limitations– Inexperienced Ulnar operators.– Attempted to cannulate even nearly absent ulnar

artery.

“…High crossover rate in Transulnar cannulation group made it inferior to Trans Radial cannulation….”

The AURA of ARTEMIS Study .Circ Cardiovasc Interv.2013;6:252-261

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•Does Experience Matter?

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Our observation:

%

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So….. Experience Does Matter..

Does Ulnar artery cannulation still remain inferior, even if performed by an Experienced operator ?

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AJULAR StudyPrerequisites

• “..Default radialist with a minimum experience of 50 transulnar cannulations ..”

• “…Cannulation attempted only if ulnar artery easily palpable and anatomy is favorable….”

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Trial Design Randomized Single center Non-Inferiority Trial

Primary end PointComposite of MACEs ,major vascular

events (large hematoma and occlusion) during hospital stay and crossover rate.

Secondary end Points•Individual Components of Primary end Points•Spasm. •Failed attempts( > 3 attempts)•Total procedural and fluoroscopy time, •Amount of contrast used

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Exclusion Criteria

• Inability to palpate either radial or ulnar artery,• Primary angioplasty,• Cardiogenic shock, • Patients on chronic hemodialysis,• Vasospastic disease (Raynaud’s disease),• Severe forearm skeletal deformities,• Post CABG.

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Patient Flow During StudyInformed Consent from all patients

Approved by Institute Ethical Committee

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Primary End Points

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% %

%Composite of

•MACEs •Major vascular events (large hematoma and occlusion) during hospital stay and •Crossover rate.

MACE’s

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%%

%

Large Hematoma

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%

Crossover

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% 4.43.8

Spasm

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%

Intention to treat Analysis

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M

Zone of Non-Inferiority

‘M’ indicates Non-Inferiority Margin, 1.93 in this case

Per Protocol Analysis

Zone of Non-Inferiority

M‘M’ indicates Non-Inferiority Margin, 1.93 in this case

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So Obvious advantage…

• … if you have expertise in ulnar cannulation, 75% of femoral artery cannulations can be avoided ….

Take Home Message

1. Trans Ulnar cannulation is also an easy, safe and comfortable procedure.

2. If used as a default strategy it is non-inferior to transradial approach, when performed by an experienced operator – “It’s Reality, not a myth”.

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Thanks

Thank you for your attention.

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