An$coagula$on Center Staten Island University Hospital

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3 An$coagula$on Center Staten Island University Hospital Who Are We? We are the largest An-coagula-on Center in New York City Started in 1998 with 60 pa-ents 2016 have an ac-ve census of 2000 pa-ents referred from all 5 boroughs of NYC, Long Island and New Jersey Center of Excellence We are one of 38 Centers in the United States to receive this designa-on from the An-coagula-on Forum An-coagula-on Forum is the largest peer organiza-on of an-coagulant service providers in North America. 1. Based these discussions there are 3 pom op-ons 3

4 An$coagula$on Center Staten Island University Hospital We are a Nurse Prac$$oner Prac$ce 6 full--me NPs and 6 per-diem 3 NPs Cer-fied An-coagula-on Care Providers (CACP) Once the pa-ent is referred to our Center by their PMD, the NP assumes full responsibility for all aspects of the pa-ent s an-coagula-on management Each NP follows her own pa-ents seeing pa-ents each day Each visit consists of POC INR tes-ng, assessment for bleeding/ clo\ng events and face to face discussion 4

5 An$coagula$on Center Focus of Center Tradi-onal Focus Out-pa-ent warfarin management and bridging therapies New Focus 1. Warfarin management and bridging therapies 2. DOAC management 3. Ini-a-on and management of in-pa-ent an-coagula-on therapies 5

6 An$coagula$on Center QUALITY INDICATORS IPRO Na-onal Organiza-on providing a full spectrum of healthcare assessment and improvement services that are dedicated to enhancing quality of care for be`er pa-ent outcome Time in Therapeu9c Range (TTR) Goal 70% Our Center averages % Na-onal average 40-60% 6

7 An$coagula$on Center Adverse Events 1. Bleeding Na-onal Average of Bleeding Events on Coumadin 1%-3% Our Center 0.25% % 2. Thrombo9c Events Na-onal Average of Thrombo-c Events on Coumadin - 1.3% 4.5% Our Center % % 7

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9 WARFARIN Historical Perspec-ve 1920 s ca`le in US and Canada dying of sweet clover disease 1941 Wisconsin Alumni Research Fund (WARF) scien-sts Karl Link abd William Schoeffel developed a synthe-c compound based on bis-coumarin 1948 approved for use as a roden-cide 1954 Dwight D. Eisenhower received warfarin post MI 2016 Why do we s-ll need this rat poison????? 9

10 Warfarin Warfarin Drawbacks Narrow therapeu-c window Slow onset of ac-on Several drug-drug and diet interac-ons Dosage requirements vary among pa-ents Long-half life Requires frequent monitoring Dietary restric-ons Some of this is good! 10

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12 Warfarin Why do we s-ll need warfarin? Mechanical valve replacements Severe renal impairment including dialysis Extremes of body weight and age groups Pa-ent compliance Triple an-thrombo-c therapy with an-platelets Cost of newer agents Real world data with warfarin extensive 12

13 Vitamin K-Dependent CloMng Factors Synthesis of Func-onal Coagula-on Factors VII IX X II

14 FACTOR FACTS AND WARFARIN Affects vitamin K dependent clo\ng factors II, VII, IX and X at approximately the following halflives: Factor II hours Factor VII 2-6 hours Factor IX hours Factor X hours

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16 Warfarin Dosing Guidelines All pa-ents need a baseline INR Evaluate pa-ent to determine warfarin sensi-vity High Sensi$vity Pa$ents 1. Use lower ini-al dose (2-5mg) - baseline INR >1.5, yrs old - significant hepa-c disease - decomponsated CHF - malnourished - malabsorp-on syndrome/ chronic diarrhea - cancer 16

17 Warfarin Dosing Guidelines High Sensivity Pa$ents - hypoalbuminemia (<2) - thyrotoxicosis - Polymorphism of CYP450 2C9 Pa-ents older that 85 yrs or those with significant drug interac-ons or risk factors should be ini-ated on doses no greater than 2.5mg 17

18 Warfarin Dosing Guidelines Moderate Sensi$vity Pa$ents Baseline INR Age years old Concurrent CYP-450 enzyme inhibitors Use moderate ini-al dose (5mg) Low Sensi$vity Pa$ents Baseline INR <1.2 Age <50; no other risk factors Use ini-al doses 5mg-7.5mg 18

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20 Bridge Study Bridging An$coagula$on in Pa$ents who Require Temporary Interrup$on of Warfarin Therapy for an Elec$ve Invasive Procedure or Surgery New England Journal of Medicine August, 2015 Funded by the Na-onal Heart, Lung and Blood Ins-tute of the Na-onal Ins-tutes of Health 20

21 Study Objec$ves; Bridge Study To compare the efficacy of bridging an$coagula$on (therapeu$c dose LMWH) with no bridging an$coagula$on (placebo) in pa$ents with Atrial Fibrilla$on who require temporary interrup$on of warfarin. To compare the safety of bridging vs no bridging (rate of bleeding/ rate of thrombo$c events) 21

22 Bridge Study Design: 1884 pa$ents were recruited from July 2009 through December 2014 from 108 sites in the United States and Canada Half the pa$ents were assigned placebo (normal saline) and the other half were assigned to receive LMWH 22

23 Bridge Study Findings: Arterial thromboembolism % ( four events among 918 pa-ents) in the nonbridging group % (three events among 895 pa-ents) in the bridging group Major Bleeding 1.3% of pa-ents (12 of 918) in the non-bridging group 3.2% (29 of 895) in the bridging group 23

24 Bridge Study Concolusions: Based upon 1B best-prac$ce evidence, pa$ents with non-valvular atrial fibrilla$on can hold warfarin x 5 days, without LMWH coverage, for elec$ve surgical or other invasive procedures 24

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26 DOACs/ NOACs/ TSOACs 4 DOACS are FDA approved -Three factor Xa inhibitors: Apixaban,Edoxaban, Rivaroxaban -One direct thrombin inhibitor: dabigatran Approved indica-ons -Preven-ons of stroke in non valvular atrial fibrilla-on -Treatment of PE/DVT and to reduce risk of recurrent VTE -Thromboprophylaxis following hip and knee arthroplasty -Dabigatran is only approved for thrombopropnylaxis in hip replacement not for knees. -Edoxaban not approved for Hip/Knee replacement 26

27 Direct Oral An$coagulants Dabigatran (Pradaxa)- Thrombin inhibitor -FDA approval 2010: stroke preven-on in non valvular Afib; approved 2014 for VTE treatment. Only one with a reversal agent Idarucizumab (praxbind) Approved in Rivaroxaban (Xarelto) XA inhibitor - FDA approval 2010/11: postop VTE prophylaxis, stroke preven-on in Afib, treatment of VTE Apixaban ( Eliquis)- Xa inhibitor -FDA approval 2012: stroke preven-on in Afib: approved 2014 for VTE prophylaxis arer major orthopedic surgery - FDA approval for VTE treatment 2014 Edoxaban(Savayasa)- XA inhibitor -FDA approval 1/2015: stroke preven-on in Afib treatment of acute VTE 27

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29 DRUG DOSING INDICATIONS Direct Oral Anitcoagulants Dosing Dabigatran (Pradaxa) - Rivaroxaban (Xarelto) 150 mg PO twice a day Must adjust for crea-nine clearance. 220mg PO once a day x days or start 110mg PO x hrs postop or 220mg on day arer surgery. 20mg daily 10mg daily :Thromboembolism/srtoke prophylaxis, DVT/PE prophylaxis, recurrent Non- valular Atrial Fibrilla-on : DVT/PE treatment : DVT/PE prophylaxis, hip replacement :Throboembolis/stroke prophylaxis non-valular Atrial Fibrilla-on. Hip replacement start 6-10 hrs postop once hemostasis established X 35. Knees x 12 days 15mg po twice a day x 21 days the convert to DVT/ PE treatment 29

30 Apixaban (Eliquis) 5mg twice a day 2.5mg twice a day for pa-ents with two of the following criteria: 80 years or older, weight less than 60kg, crea-nine > mg daily 2.5mg po twice a day 10mg po twice a day x 7 days then convert to 5mg po twice a day Thromboembolism/srtoke prophylaxis, Non- valular Atrial Fibrilla-on Hip replacement start 6-10 hrs postop once hemostasis established X 35. Knees x 12 days DVT/PE prophylaxis, recurrent DVT/ PE treatment Endoxaban (Savaysa) 60mg po daily Thromboembolism/srtoke prophylaxis, Non- valular Atrial Fibrilla-on, 9/26/16 30

31 Posi$ves Oral administra-on Rapid Onset No monitoring Short Half-life Limited interac-ons No bridging Convenient Superior in Intracranial risk Direct Oral An$coagulants Nega$ves Expensive No monitoring GI disturbances No data in special popula-ons ( i.e. Valvular disease, prosthe-c heart valves, hypercoagulable states, oncology, pediatrics, pregnancy Reversal op-ons are available, but limited ( for now Cannot use with crcl < 30 31

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34 Gloria Study Study Design Non-interven-onal registry study of pa-ents diagnosed with non-valvular atrial fibrilla-on, Inves-gates pa-ent characteris-cs influencing the choice of an-thrombo-c treatment Collects real world data on important outcome events 34

35 Gloria Study Eligibility Criteria - Diabetes mellitus - History of stroke, TIA, or systemic embolism - Vascular disease defined as prior MI, PAD, or complex aor-c plaqie - Age >65 - Female gender 35

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37 Gloria Study Study Timeline: Study consists of three separate phases Study is designed to characterized newly diagnosed non-valvular Atrial Fibrilla-on pa-ents in different regions of the world and to describe current pa`erns of an-thrombo-c treatments Currently in Phase 3/3 which is designed to collect safety data and outcomes of registry pa-ents Informa-on is collected at -me of enrollment, in 6 months, 12 months, 24 and 36 months 37

38 Gloria Study Data Collec-on Informed consent Medical history Demographic data Vital signs/ height/ weight/ BMI/ serum crea-nine An-thrombo-c therapy and any changes Therapeu-c or diagnos-c interven-ons Monitoring of adverse events, concomitant medica-ons, and compliance with AFIB treatment 38

39 Northwell Improvement Collabora$ve: Reducing An$coagula$on-Related Adverse Events The Ins$tute for Healthcare Improvement (IHI) Collabora$ve Model Christine Rivas ANP-BC Team Lead : Northwell AC Collaborative Anticoagulation Center Nurse Practitioner Anticoagulation Services, SIUH

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