1/13/2014. Critical Care Practice in the ED: Oral Anticoagulant related bleeding. No financial Disclosures

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1 Critical Care Practice in the ED: Oral Anticoagulant related bleeding Dowlatshahi D et al. Stroke. 2012;43: No financial Disclosures May discuss off-label uses of medication/therapies Case History Review Pertinent Pharmacology Review literature Recommendations for management 1

2 75 yo female with H/O CAD, CHF, Afib, EF ~35%,HTN, Type 2 DM, TIA, PVOD presents after tripping and falling at home and hit her head against the concrete Patient is awake and alert, moves all 4 extremities Not sure if she lost consciousness VS: T=37 HR=100 RR=18 BP 160/90 Oxygen Sat=99% HEENT- Hematoma right parietal region, No other bleeding Chest- CTAB, No rales CVS- Irregular tachycardic rhythm, No murmurs Abd- Soft, NT Neuro- Awake and oriented x3, No focality Meds- Carvedilol, Losartan, Pantoprazole, Bumetamide, Glucophage and Dabigatran, ASA What else do you want to know about her medications? What labs/ ancillary studies if any? Should she even be on anticoagulation? _anticoagulants.pptx Accessed 12/2013 Feinberg W, Black J. Arch Int Med 1995: 155;

3 As population ages there is increased incidence of A fib Growing numbers of patients have cardiac procedures Anticoagulation is on the rise Boehringer (Dabigatran) posted 11.5% increase revenues 2012 ~$14.7EU 76% Pradaxa sales 2012 $670M USD Bayer Xarelto(Rivaroxaban) sales $219M EU 237% 2013 Pfizer/ BMS Eliquis (Apixaban) sales $12 M USD Yearly incidence of major bleeding during OAC is 2-5% Fatal bleeding 0.5-1% Intracranial bleeding % VKA utilization increased 300% between The 30-day mortality of warfarin associated ICH ~50% Symptomatic ICH more common in patients on anticoagulants + anti-platelets Antiplatelet agent use associated with a higher incidence of TICH HFH NCCU CoRICH Trial 2971 pts with ICH 122 on Warfarin (4.1%) Mean Admit GCS 10 (3-15) Mean pre-therapy INR 4.20( ) Mean post-therapy INR 1.25 ( ) Elapsed time for re-check 155 min (7-1090) Reversal included Vit K in 36 pts (87.8%) FFP in 34 pts (82.9%) Act Factor 7 in 19 pts (46.3%) PCC in 20 pts (48.7%) With permission T. Abdelhak, MD Co RICH Trial in press 3

4 WARFARIN Delayed onset of action Needs bridging Multiple Interactions Needs monitoring Side Effects HEPARIN Variable response Needs monitoring Only available parenterally Heparin Induce Thrombocytopenia Not ideal for long-term management Clopidogrel -Normal vascular endothelium(collagen) -Functional platelets -Normal vwf -Normal fibrinogen Tintinalli 7 th ed Platelet activation mechanisms (modified after Storey R.F. Biology and pharmacology of the platelet P2Y12 receptor. Curr Pharm Des 2006;12: ). Coagulation Pathways : Secondary Hemostasis Contact activation (Intrinsic Pathway) Damaged Surface XII XI Heparin AT Tintinalli 7thed XIIa XIa Prothrombin (II) Ca 2 + IX IXa VIIIa X V Xa, PL Va, Ca 2+ VIII Tissue factor (Extrinsic Pathway) TF, Ca 2+ VIIa VII Thrombin(IIa) Fibrinogen X Cross-linked fibrin clot Fibrin Common Pathway XIIIa Warfarin Apixaban Rivaroxaban Dabigatran XIII 4

5 Dabigatran Pradaxa Rivaroxaban Xarelto Apixaban Eliquis Clopidogrel Plavix Warfarin EHJ (2013) 15, Mech of Action Time to Peak (hrs) Clopidogrel Warfarin Dabigatran Rivaroxaban Apixaban P2Y 12 Plat Inhibits Synth VKF Inhib Clot/ Free Thrombin (IIa) Direct Inhib of FXa Half-life (hrs) (11-13 elderly) Bioavailability % % no food 100% food Direct Inhib of FXa Monitoring Verify Now? INR ECT FXa assay Fxa assay Renal Excretion Interactions 50% 1% 80% 66% 50% CYP 3A4/5, CYP2C19 Aspirin, NSAID CYP2C9, CYP1A2, CYP3A4 Dietary VK P-gp inhib CYP3A4 inhib P-gp inhib CYP3A4 Trial Drug being compared # subjects CHADS2* (mean) TTR ** (mean) RE-LY Dabigatran 18, % ROCKET-AF Rivaroxaban 14, % ARISTOTLE Apixaban 18, % All randomized ; RE-LY unblinded All designed as non-inferiority trials Primary outcome was stroke or embolism All funded by manufacturer NEJM 2009; 361:1139 NEJM 2011; 365:883 NEJM 2011; 365:981 *CHF,HTN,AGE,DM, Stroke= CHADs **TTR- Time in Treatment Range 5

6 Data from RE-LY, ROCKET-AF and ARISTOTLE New data Inc bleeding risk in association with Antiplatelet Agents by 60% (~VKA) What if a patient is on NOAC and presents with Stroke Symptoms <3h? RE-LY trial 46 yo on Dabi presented with CVA 4.5hr Last dose 7 h PTA. Neuro improvement w/o hemorrhagic complication RE-LY trial higher rate of ACS in Dabi (0.81%) vs Warfarin (0.64%/yr) RE-DEEM(ACS) trial incidence bleeding What about extremes of weight <50kg or >100 kg Pts < 50 had higher trough levels and >100 kg had lower levels use Warfarin Switching from Warfarin to Dabi ( wait til INR < 2) Switching from parenteral SC dose. Give Dabi at the next schedule dose time or 2 hrs before Meta analysis JAMA Neurology 31 K NOAC vs 25K Warfarin 186 ICH events in NOAC 317 ICH events Warfarin Abs risk for ICH 0.58% NOACs /1.24% Warfarin NOACs prevented 131 ICHs. Absolute difference was 0.65% You have a 99.4% chance of not having ICH NOAC/98.8% Warfarin Lancet 29K NOAC vs 29K Warfarin 911 stroke/systemic emboli vs 1107 Warfarin Abs risk 3.1% NOAC vs 3.8% Warfarin Absolute difference 0.7% 96.9% chance of no embolic event NOAC vs 96.2% Warfarin Up to 50X more for NOAC 6

7 Circulation, Volume XIX, January 1959 Dabigatran: At trough aptt > 2x ULN suggests excess bleeding risk Dabigatran: At trough Diluted Thrombin Time (dtt) > 200 ng/ml or > 65 s excess bleeding risk Dabigatran: At trough Ecarin Clotting Time (ECT) > 3x ULN: excess bleeding risk Rivaroxaban: PT Prolonged, may indicate excess bleeding risk but local calibration req d Still waiting on data regarding Anti-Fxa chromogenic assays Clopidogrel (Plavix) Supportive Care Hold Antiplatelet/Discontinue Administer platelets Administer PRBCs as needed 7

8 Warfarin (Coumadin) Minor Bleeding Omit dose of Warfarin Vitamin K mg PO/IV Moderate Bleeding Hold Warfarin Vitamin K 10 mg IV x 1 K Centra based on INR INR (25 u/kg Max 2500)/INR 4-6 (35U/kg Max 3500)/ INR >6 (50U/Kg Max 5000) Life Threatening Bleeding Vitamin K 10 mg IV K Centra INR dosed FFP ml/kg for volume of massive transfusion Dabigatran (Pradaxa) Minor Bleeding Delay next dose/ Discontinue Maintain adequate Urine output Moderate-Severe Bleeding As above + Activated Charcoal if ingestion 1-3 hr PTA May consider Kcentra Life-Threatening Bleeding As above + consider emergent hemodialysis Consider Kcentra If bleeding continues consider FEIBA NF 100u/kg If bleeding consider Factor VIIA Rivaroxaban (Xarelto) Minor Bleeding Delay dose/discontinue Maintain adequate urine output Moderate-Severe Bleeding If ingestion past 8 hrs Activated Charcoal 50g PO x 1 Kcentra 25U/kg x 1 Life-Thretening Bleeding Kcentra 50 U/kg x 1 If bleeding continues may consider FEIBA NF 100u/kg x 1 If bleeding continues may consider Factor VIIa 8

9 Apixaban (Eliquis) Minor Bleeding Delay next dose/ Discontinue Maintain adequate urine output Moderate Severe Bleeding If ingestion within last 6 hours Activated Charcoal 50 g PO x 1 Kcentra 25 U/kg x 1 Life-Threatening Bleeding Kcentra 50 U/kg x 1 If bleeding continues consider FEIBA NF 100 U/kg x 1 If bleeding continues consider Factor VIIa Name Contents Half-Life Use Dose Cost Vitamin K Fresh frozen Plasma 4 Factor K Centra Protamine SO4 Phytonadion e All coag Fs, vwf, fibrinogen, ADAMST13 II, VII, IX, X, Protein C+S Protamine SO h VKA 5-10 mg slow IV days effect 10 min Varies dep on Factor VKA 10 cc/kg 1 u 2.5% 4 u 10% $20 $ NOACs 25u/kg $3600-$ min Heparin 1 mg per 1000u Heparin $100 Platelets platelets 3-4 d AP 6 units $500 Name Contents Half-life Use Dose Cost FEIBA NF Bebulin VH, Profilnine SD II, VIIa,IX, X II,IX, X (v.little VII) Novo Seven VII < 60 min Effect 10 min $9660 9

10 Supportive IV access, volume expanders, hemodynamic support, oxygen, packed RBCs Correct acidosis, counteract hypothermia Reduce drug exposure Delay next dose of NOAC or discontinue drug Hold antiplatelet Active charcoal orally if last dose of NOAC < 3 hrs ago Hemodialysis- only for dabigatran (?) Improvement of hemostasis Compression of accessible bleeding source Injection of epinephrine topically Correct hypocalcemia Apply topical thrombin or fibrin glue Antifibrinolytic agents Desmopressin if platelet inhibition has occurred Platelet transfusion- for thrombocytopenia or if clopidogrel or prasugrel has been given FFP for dilutional coagulopathy Surgical intervention Humanized highly selective monoclonal antibodies to dabigatran Genmin Lu, Francis R DeGuzman, Stanley J Hollenberg. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nature Medicine 19, (2013) 10

11 75 yo female with H/O CAD, CHF, Afib, EF ~35%,HTN, Type 2 DM, TIA, PVOD presents after tripping and falling at home and hit her head against the concrete Patient is awake and alert, moves all 4 extremities Not sure if she lost consciousness Meds- Carvedilol, Losartan, Pantoprazole, Bumetamide, Glucophage and Dabigatran, ASA What else do you want to know about her medications? Last dose, What labs if any? If at trough could measure PT/INR, Head CT Should she even be on anticoagulation? Based on her CHADS VASC score -- Yes Key to managing anticoagulant bleeding is to provide supportive care Familiarity with mechanism of action of the agent When was last dose taken Knowledge of available reversal agents and local protocol 11

12 Thanks to Michigan College of Emergency Physicians All Speakers, Students, Residents and Sponsors!! 12

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