NOACs and Bleeding

Huy Tran

Terminology

• NOAC– Novel oral anticoagulants– Non VKA oral anticoagulants– (NO Anticoagulation)

• DOAC– Direct oral anticoagulants

Other Terms

• ODI– Oral Direct Inhibitors

• SODA– Specific Oral Direct Anticoagulant

• TSOAC– Target Specific Oral Anticoagulant

Vote 2014

• DOAC 29.9%• NOAC 28.6%• TSOAC 23.4%

• North America and European• Australasia not asked to participate

New anticoagulants

Direct Thrombin Inhibitors

- Dabigatran

Factor Xa Inhibitors

- Rivaroxaban

- Apixaban

- Edoxaban

Management of Bleeding

• Prevention• Treatment

Prevention of Bleeding

• Anticoagulant Selection• Patient and Dose Selection• Management of Interruption of Treatment

-5 -4 -3 -2 -1 OR 1 2 3 4 5 6

DAYS

“No”: DVT prophylaxis with LMWH

or prophylactic dose of

NOAC

Post -Procedure Use of NOACs

Restart NOAC at

therapeutic doses

“Yes”: Restart NOAC at

therapeutic doses

Ask yourself: “Is it OK that the

patient be fully anticoagulated 2

hours after 1st dose?”

1

3

“No” Delay restart of DOAC at therapeutic

doses

2

Reversal of NOACs

• Remove Drug• Active coagulation to overcome drug effect• Neutralise drug

Pradaxa (Dabigatran) Reversal

Patients received 5 g of intravenous idarucizumab, which was administered as two 50-ml bolus infusions, each containing 2.5 g of idarucizumab, no more than 15 minutes apart. The 5-g dose was calculated to reverse the total body load of dabigatran that was associated with the 99th percentile of the dabigatran levels measured in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial.

*Pollack C, et al. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015; 373:511-520.

Approved and Available

• Cost- 5g is $US3500 (wholesale)

*Siegal DM, et al. Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity. N Engl J Med. 2015; 373:2413-2424 .

ANNEXA-4

• Phase III• 270 expected to be recruited• Jan 2015 to Nov 2022

Local hemostatic measures

Hold 1 or more doses of dabigatran

Mild bleedingModerate-severe

Bleeding*Life-threatening

Bleeding*

Manage bleeding (compression, surgery)

Fluid diuresis Transfuse RBCs or

platelets if needed Oral charcoal if dose

<2 hrs before

If aPTT >40 sec, consult TE or Transfusion Medicine

When was last dose? FBE, creatinine aPTT, TT (dTT)

Patient with bleeding on dabigatran

Contact Transfusion Medicine

Tranexamic acid (1 G IV followed by 1 G infusion over 8 hours)

Hemodialysis might be helpful

Consider FEIBA**

Local hemostatic measures

Hold 1 or more doses of drug

Mild bleedingModerate-severe

Bleeding*Life-threatening

Bleeding*

Manage bleeding (compression, surgery)

Fluid diuresis Transfuse RBCs

or platelets if needed

Oral charcoal if dose <2 hrs before

If abnormal, consult TE or Transfusion Medicine

When was last dose? FBE, creatinine INR/anti-Xa level

Patient with bleeding on rivaroxaban/apixaban

Contact Transfusion Medicine

Tranexamic acid (1 G IV followed by 1 G infusion over 8 hours)

Consider FEIBA*/PCC

Future…