Update on Novel (and well-worn) Anticoagulants and Thrombolytics. Melinda T. Ryan, RN, BSN, MSN, CNP Department of Vascular Medicine Cleveland Clinic

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1 Update on Novel (and well-worn) Anticoagulants and Thrombolytics Melinda T. Ryan, RN, BSN, MSN, CNP Department of Vascular Medicine Cleveland Clinic

2 None Disclosures

3 New options!

4 Acronyms for new oral anticoagulants NOACs: new oral anti-coagulants, novel oral anti-coagulants, non-monitored oral anti-coagulants, non-warfarin oral anticoagulants, non Vitamin K antagonist oral anticoagulants DOACs: direct oral anti-coagulants TSOCs: target specific oral anticoagulants ODIs oral direct inhibitors

5 Factor Xa inhibitors Apixaban (Eliquis) Rivaroxaban (Xarelto)

6 Coagulation pathway

7 Apixaban FDA approved indications for treatment Nonvalvular a-fib Treatment of DVT/PE Reduction in the risk of recurrent DVT/PE following initial therapy Prophylaxis for DVT after orthopedic surgery Trials Non-valvular afib : ARISTOTLE DVT/PE: AMPLIFY, Reduction in the risk of recurrent DVT/PE: AMPLIFY-EXT Prophylaxis for orthopedic surgery: ADVANCE 1-3

8 Apixaban Dosing Non-valvular afib 5 mg twice daily Dose adjustment for NVAF pts w/following criteria - Age > 79 years - Body weight <60 kg - Serum creatinine >1.5 mg/dl 2.5 mg twice daily DVT/PE 10 mg twice daily for the first 7 days Then 5 mg twice daily

9 Apixaban dosing Reduction in the risk of recurrent DVT/PE following initial therapy 2.5 mg twice daily after at least 6 months of treatment for DVT/PE DVT/PE prophylaxis after orthopedic surgery 2.5 mg twice daily x35 days starting hours after hip replacement surgery 2.5 mg twice daily for 12 days after hours after knee replacement surgery

10 Apixaban Pharmacologic profile Onset of action: 3-4 hours Protein Binding ~87% Metabolism: predominantly via CYP3A4/5 Bioavailability ~50% Time to peak 3-4 hours ½ life: ~ 12 hours Excretion: Urine ~27% as parent drug, feces

11 Contraindications to Apixaban Acute bleeding Severe reaction to ELIQUIS (anaphylactic reactions) Use w/caution ASA, anti-platelets, NSAIDs, thrombolytics, SSRI, SNRIs NOT approved for prosthetic heart valves Recommends against use in acute PE in a hemodynamically unstable pt or pts who require thrombolysis or pulmonary embolectomy Coadministration with strong dual inhibitors of CYP3A4 and P- gp should be avoided Examples: - Ketoconazole - Itraconazole - Ritonavir - Clarithromycin - Rifampin - Carbamazepine - St. John s wort

12 Apixaban Use caution w/ pts who underwent spinal and epidural anesthesia Per package insert Catheters should not be removed earlier than 24 hours after last administration of apixaban The next dose of apixaban should not be administered earlier than 5 hours after the removal of the catheter If traumatic puncture delay the administration of apixaban x48 hours

13 Rivaroxaban FDA approved indications for treatment nonvalvular a-fib PE/DVT reduce the risk of recurrence of DVT and/pe prophylaxis for orthopedic surgery Trials A-fib: ROCKET AF DVT/PE EINSTEIN DVT and PE Reduce the risk of recurrent DVT/PE: EINSTEIN-EXT Prophylaxis for orthopedic surgery RECORD 1-4

14 Rivaroxaban Dosing Nonvalvular Afib: 20 mg daily w/evening meal: Pts with CrCl>50 ml/min 15 mg daily w/evening meal Patients CrCl ml/min DVT/PE 15 mg TWICE daily x21 days Then 20 mg once daily w/food

15 Rivaroxaban dosing Extended Treatment: 20 mg once daily with food Orthopedic surgery Prophylaxis Knee: 10 mg once daily x 12 days Hip: 10 mg once daily x35 days Initial dose should be taken at least 6-10 hours after surgery once hemostasis established

16 Rivaroxaban Pharmacologic Profile Absorption: Rapid Protein Binding: ~92-95% primarily to albumin Metabolism: Hepatic via CYP3A4/5 and CYP2J2 Bioavailability: Absolute bioavailability: 10 mg dose: ~80% to 100%; 20 mg dose: ~66% (fasting; increased with food) ½ life: 5-9 hours for healthy subjects years hours in the elderly Time to peak: 2-4 hours Excretion: Urine (66% primarily via active tubular secretion, feces

17 Contraindications to Rivaroxaban Acute pathological bleeding Severe hypersensitivity to rivaroxaban Use w/caution: ASA, anti-platelets, NSAIDs, thrombolytics NOT approved for prosthetic heart valve Avoid concomitant administration of rivaroxaban w/cyp3a4 and drug transport systems Ex: Rifampin, phenytoin, carbamazepine, St. John s wort

18 Rivaroxaban Pts w/renal impairment receiving full dose rivaroxaban in combination w/drugs classified as combined P-gp and weak or moderate CYP3A4 inhibitors may have increase in exposure EX: amiodarone, diltiazem, verapamil, quinidine, ranolazine, dronedarone, felodipine, erythromycin, and azithromycin

19 Rivaroxaban Use w/caution in pt undergoing spinal/epidural Anesthesia An epidural catheter should not be removed earlier than 18 hours after last administration of Rivaroxaban. The next Rivaroxaban dose should not be administered earlier than 6 hours after the removal of catheter If traumatic puncture hold x24 hours

20 Factor Xa Inhibitors things to consider Both Apixaban and rivaroxaban can effect INR (i.e. elevate INR) w/out direct correlation to level of anticoagulation Currently there is no therapeutic assay, to check levels of drug No antidote or reversal agent in life threatening bleeding Increased risk of stroke after discontinuation in nonvalvular atrial fib

21 Converting to Factor Xa DC warfarin Begin apixaban or rivaroxaban once INR <3 Note onset of action is rapid if converting from LMWH or parental agent, begin Factor Xa when next dose of injection is due, or stop heparin gtt begin Factor Xa inhibitor

22 Direct thrombin inhibitors Dabigatran

23 Dabigatran FDA approved: Nonvalvular afib DVT/PE (w/bridging) To reduce the risk of recurrence of DVT/PE in pts who have been previously treated Trials Nonvalvular afib: RE-LY DVT/PE: RECOVER I, II To reduce the risk of recurrence of DVT/PE in pts who have been treated: RE-MEDY

24 Dabigatran Dosing Nonvalvular afib: 150 mg twice daily CrCl>30 ml/min 75 mg twice daily CrCl ml/min DVT/PE 5-10 days of parental anticoagulant (LMWH, Fondaparinux, IV unfractionated heparin Then: 150 mg twice daily

25 Dabigatran Pearls Take w/w/out food but should be taken with a full glass of water Caution in pts w/gi bleeding or ulcer or dyspepsia, gastritis Dabigatran capsules light sensitive, come in blister packs or bottles but should not be placed in pill containers

26 Dabigatran Pharmacologic Profile Absorption: Rapid, initially slow postoperatively Protein Binding 35% Metabolism: Hepatic; dabigatran etexilate is rapidly and completely hydrolyzed to dabigatran (active form) by plasma and hepatic esterases Bioavailability 3-7% ½ life: hours; Elderly: hours; Mild-to-moderate renal impairment: hours; Severe renal impairment: 28 hours Time to Peak: plasma: Dabigatran: 1 hour; delayed 2 hours by food (no effect on bioavailability) Excreted: Urine (80%)

27 Contraindication to Dabigatran Life threatening bleeding Sensitivity to dabigatran Prosthetic heart valves (trial ended early due to more thromboembolic events and bleeding Use w/caution: Age >75 years of age Have kidney problems Have hx of GI bleeding Concomitant use of dabigatran and P-gp Inducers and inhibitors (dronedarone, ketoconazole)

28 Dabigatran Use w/caution in spinal/epidural anesthesia or puncture Drug profile does not give specific recommendations for dosing

29 Dabigatran No monitoring for compliance Can effect aptt, may use aptt to predict excretion of drug (not directly reliable) Also can use ECT or thrombin time No reversal agent Dialysis has been used in life threatening cases Activated charcoal if recent ingestion

30 Low molecular weight heparin Dalteparin Enoxaparin

31 Low molecular weight heparin

32 Dalteparin FDA indications: DVT prophylaxis in patients undergoing abdominal surgery, orthopedic surgery, medical pts prevention of ischemic complications in patients with unstable angina or non-q-wave myocardial infarction on concurrent aspirin therapy in patients with cancer, extended treatment (6 months) of acute symptomatic venous thromboembolism (DVT and/or PE) to reduce the recurrence of venous thromboembolism Unlabeled use: (US) treatment of acute DVT/PE

33 Dalteparin dosage prophylactic dose: 5,000 IU SC daily DVT/PE dose: 200 IU/kg SC injection daily x 30 days Followed by 150 IU/kg for maintenance therapy Be aware of weight restrictions in obese pts Syringe sizes: 5,000 IU 7,500 IU 10,000 IU 12,500 IU 15,000 IU 18,000 IU

34 Dalteparin Pharmacologic Profile Onset of action: 1-2 hours Protein binding: Low affinity for plasma proteins Bioavailability: SubQ: 81% to 93% ½ life elimination 3-5 h; 6-7h renal impairment Time to peak, serum: ~4 hours Excretion: Primarily renal

35 Contraindications to Dalteparin Active bleeding Hypersensitivity reaction to Dalteparin Active HIT or history of HIT Kidney Dysfunction CrCl <30 Use w/caution: extremes in weigh (high or low) Max dose of Dalteparin 18,000 IU syringe Monitor closely if impaired renal function Examine for safe SC injection sites in low body weight pts Use w/caution in concomitant: NSAID, ASA, anti-platelet agents

36 Enoxaparin FDA approved: ACS (acute coronary syndrome) Acute STEMI/NSTEMI DVT prophylaxis in orthopedic, abdominal surgery and medical pts DVT/PT treatment

37 Enoxaparin Dosing ACS: different protocols but used IV in PCI then: 1 mg/kg q mg/kg q 24 DVT/PE 1 mg/kg q 12 or 1.5 mg/kg q 24 DVT prophylaxis medical/surgical pts Lovenox 40 mg daily Except: Total knee replacement Lovenox 30 mg q 12 Bariatric surgery 40 mg q 12 or 60 mg q 12

38 Enoxaparin Pharmacologic profile Onset of action:3-5 hours Protein binding: does not bind to heparin binding proteins Metabolism: Hepatic, to lower molecular weight fragments (little activity) ½ life; 4.5 to 7 hours Excretion: Urine (40% of dose; 10% as active fragments)

39 Contraindications to Enoxaparin Life threatening bleeding Anaphlyactic reaction to injections Kidney dysfunction CrCl <30 Pt w/active heparin induced thrombocytopenia or history of HIT Use w/caution: Extremes of weight Low and high Max dose is 150 mg Examine for safe SC injection sites in low body weight pts Use w/caution in concomitant: NSAID, ASA, anti-platelet agents Use w/caution in impaired renal function

40 LMWH pearls At times very expensive out of pocket cost, ensure pt can afford co-pay prior to leaving hospital or clinic Can check LMWH assay to ensure compliance or in extremes of weight (low or high) or pregnant patients LMWH assay should be drawn 4 hours after 3 rd dose of enoxaparin or dalteparin Target LMWH assay Use w/caution in spinal/epidural anesthesia LMWH is partially reversible w/protamine in life threatening bleeding unlabeled use: IV: Note: Anti-Xa activity is never completely neutralized (maximum: ~60% to 75%).

41 Protamine dosage for LMWH Enoxaparin Last dose administered in 8 hours: Dose of protamine should equal the dose of enoxaparin administered. Therefore, 1 mg of protamine sulfate neutralizes 1 mg of enoxaparin. Enoxaparin administered in > 8 hours or if it has been determined that a second dose of protamine is required (eg, if aptt measured 2-4 hours after the first dose remains prolonged or if bleeding continues): 0.5 mg of protamine sulfate for every 1 mg of enoxaparin administered Dalteparin 1 mg protamine for each 100 anti-xa units of dalteparin if PTT prolonged 2-4 hours after first dose (or if bleeding continues), consider additional dose of 0.5 mg for each 100 anti-xa units of dalteparin or tinzaparin. Note check allergies, fish allergy Protamine contraindicated Use caution in male pts w/surgical history of vasectomy

42 CLOT trial 2003 NEJM Compared Dalteparin vs. warfarin in malignancy pts The incidence of recurrent thromboembolism in the dalteparin only group was significantly less than the oral anticoagulation group. There was no significant difference in bleeding or mortality detected between the two groups. This trial is why LMWH injections are preferred over warfarin in malignancy patients

43 Injectable factor Xa Fondaparinux FDA indications: DVT prophylaxis in patients undergoing surgery for orthopedic surgery, abdominal surgery. Treatment of acute PE/DVT Unlabeled Use: Prophylaxis in pts w/history of HIT, treatment of acute thrombosis (unrelated to HIT) in patients with a past history of HIT; acute symptomatic superficial vein thrombosis ( 5 cm in length) of the legs

44 Fondaparinux Pharmacologic Profile Absorption: Rapid and Complete Protein Binding: 94% to antithrombin III Bioavailability: SubQ: 100% ½ life hours, prolonged in renal dysfunction Time to Peak: Time to peak: SubQ: 2 to 3 hours Excretion: Urine (~77%, unchanged drug)

45 Fondaparinux Dosing Prophylactic Dose: in adults pts > 50 kg 2.5 mg SC daily Acute DVT/PE: < 50 kg: 5 mg SC injection daily kg: 7.5 mg SC injection daily >100 kg: 10 mg SC injection daily May be a better option for morbidly obese pts (trials included pts up to 180 kg) Case reports of Fondaparinux induced HIT

46 Contraindications to Fondaparinux Active Bleeding Hypersensitivity reaction to injections CrCl <30 Use w/caution in spinal/epidural anesthesia pts Use w/caution in concomitant: NSAID, ASA, anti-platelet agents Use w/caution in impaired renal function

47 Vitamin K Antagonist Warfarin Extrinsic Pathway Suppresses Protein C/S, Factors II, VII, IX, X

48 Warfarin

49 Warfarin FDA indications: Prophylaxis and treatment of thromboembolic disorders (eg, venous, pulmonary) and embolic complications arising from atrial fibrillation or cardiac valve replacement Adjunct to reduce risk of systemic embolism (eg, recurrent MI, stroke) after myocardial infarction

50 Warfarin Pros and Cons Pros Tried and true medication Well studied and understood Fully reversible w/life threatening bleeding (Vitamin K) Only anticoagulant available for pts w/crcl <30 Only approved anticoagulant for long-term AC for mechanical valves Lab testing that has therapeutic level (INR) Cons Need for monitoring/frequent lab draws Multiple med interactions Diet interactions Even in clinical trials INRs within target range 36%-68% of time In acute VTE must bridge w/parental agent IV UF heparin, LMWH, Fondaparinux for minimum 5 days and INR>2 for 24 hours

51 2012 CHEST guidelines In patients with DVT of the leg and no cancer, we suggest VKA therapy over LMWH for long-term therapy (Grade 2C) For patients with DVT and no cancer who are not treated with VKA therapy, we suggest LMWH over dabigatran or rivaroxaban for longterm therapy (Grade 2C) In patients with DVT of the leg and cancer, we suggest LMWH over VKA therapy (Grade 2B). In patients with DVT and cancer who are not treated with LMWH, we suggest VKA over dabigatran or rivaroxaban for longterm therapy (Grade 2B).

52 2012 CHEST Guidelines Remarks ( ): Choice of treatment in patients with and without cancer is sensitive to the individual patient s tolerance for daily injections, need for laboratory monitoring, and treatment costs. Treatment of VTE with dabigatran or rivaroxaban, in addition to being less burdensome to patients, may prove to be associated with better clinical outcomes than VKA and LMWH therapy. When these guidelines were being prepared (October 2011), post marketing studies of safety were not available. Given the paucity of currently available data and that new data are rapidly emerging, we give a weak recommendation in favor of VKA and LMWH therapy over dabigatran and rivaroxaban, and we have not made any recommendations in favor of one of the new agents over the other.

53 NOACs the unknown.. Effective in malignancy patients? Hypercoaguable states (i.e. lupus anticoagulant)? Arterial thrombosis? Mechanical valves? Heparin induced thrombocytopenia? Pregnant patients? Still w/short term clinical experience in NOACs FDA approval for VTE: Rivaroxaban approved in 11/2012 Dabigatran 4/2014 Apixaban 8/2014

54 Warfarin is not going away Only option: Dialysis patients Mechanical valves borderline renal functions High risk bleeding pts (fully reversible)

55 Case Study y/o female presents to internal medicine clinic w/left calf pain and tightness. Has recent history of ankle fracture 4 weeks ago and in a cast. No plans for surgery Duplex US positive for L popliteal/gastroc DVT Hgb 11.9 Platelets 216,000 Creatinine 0.70 PT/INR 0.9

56 What would you do? #1 1. LMWH to warfarin 2. Fondaparinux to warfarin 3. LMWH/Fondaparinux x5-10 days then Dabigatran 4. Apixaban 5. Rivaroxaban Note female reproductive years must counsel on birth control methods

57 Case Study 2 56 y/o male w/crohn s disease s/p colectomy and end ileostomy. Postop w/ shortness of breath and tachycardia and found to have R lobar PE and B/L subsegmental PE Duplex positive for L femoral DVT Consulted in the hospital for AC management Hgb 9.0 Platelets 180,000 Creatinine 1.2

58 What would you do? #2 1. Heparin to warfarin 2. LMWH/Fondaparinux to warfarin 3. LMWH/Fondaparinux x5-10 days then Dabigatran 4. Apixaban 5. Rivaroxaban

59 Case Study 3 55 y/o female history of DVT in the past x3. First after pregnancy, received 6 months of warfarin. 2 nd after knee replacement surgery 10 years later, received 3 months of warfarin. 3 rd after gallbladder surgery (overnight hospital stay) and told she should be on life long Coumadin Seen in Vascular Medicine Clinic. Inquiring about these new medications I keep seeing on TV instead of warfarin Hgb 10.9 Platelets 175,000 Creatinine 0.89

60 What would you do? #3 1. Continue warfarin 2. LMWH/Fondaparinux monotherapy 3. LMWH/Fondaparinux x5-10 days then Dabigatran 4. Apixaban 5. Rivaroxaban

61 Case Study 4 65 y/o male presents to the ER w/swollen left leg and duplex US reveals L external iliac/common femoral/femoral/popliteal DVT R gastroc/pt DVT. Pt recently diagnosed w/non-small cell lung adenocarcinoma and is undergoing chemotherapy Admitted to hospital for further work-up. Vascular medicine consulted Hgb 8.7 Platelets 156,000 Creatinine 1.0

62 What would you do? #4 1. LMWH monotherapy LMWH to warfarin 2. Fondaparinux to warfarin 3. LMWH/Fondaparinux x5-10 days then Dabigatran 4. Apixaban 5. Rivaroxaban

63 Thrombolytic FDA approved: STEMI, massive PE, acute stroke, CVC catheter clearance (low dose), Unlabeled use: peripheral arterial occlusion, Complicated parapneumonic effusion, prosthetic valve thrombosis Alteplase

64 Alteplase Pharmacologic Profile Duration: >50% present in plasma cleared ~5 minutes after infusion terminated, ~80% cleared within 10 minutes; fibrinolytic activity persists for up to 1 hour after infusion terminated (Semba, 2000) Excretion: Clearance (in patients with acute MI receiving accelerated regimen): Rapidly from circulating plasma (572 ± 132 ml/minute) (Tanswell, 1992), primarily hepatic; >50% present in plasma is cleared within 5 minutes after the infusion is terminated, ~80% cleared within 10 minutes (Semba, 2000)

65 TPA in massive PE 100 mg over 2 hours; may be administered as a 10 mg bolus followed by 90 mg over 2 hours Heparin gtt to be started post thrombolysis as per orders by medical team and pharmacy

66 What constitutes high risk or massive PE? PE leading to cardiogenic shock: SBP <90 for at least 15 minutes and or need for vasopressors PLUS end-organ dysfunction or PE that causes cardiorespiratory arrest or PE that causes respiratory failure requiring mechanical ventilation or A pressure drop of >40 mmhg for greater than 15 minutes not due to sepsis or hypovolemia

67 2012 CHEST Guidelines for TPA in PE In patients with acute PE associated with hypotension (eg, systolic BP, 90 mm Hg)who do not have a high bleeding risk, we suggest systemically administered thrombolytic therapy over no such therapy (Grade 2C) In most patients with acute PE not associated with hypotension, we recommend against systemically administered thrombolytic therapy (Grade 1C).

68 Contraindications to thrombolytic therapy for DVT/PE Absolute contraindications: Prior intracranial hemorrhage Known structural cerebral vascular lesions Known malignant intracranial neoplasm Ischemic stroke within 3 months (excluding stroke with 3 hours) Suspected aortic dissection Active bleeding or bleeding diathesis (excluding menses) Significant closed-head trauma or facial trauma within 3 months

69 Relative contraindications to thrombolytic therapy Hx of chronic, severe, poorly controlled HTN Severe uncontrolled HTN on presentation (SBP >180 mmhg or DBP >110 mmhg) Hx of ischemic stroke more than 3 months prior Traumatic or prolonged (>10 minutes) CPR Major surgery <3 weeks Recent (within 2-4 weeks) internal bleeding Recent LP puncture within 1 week Non compressible vascular punctures Recent invasive procedure Pregnancy Active peptic ulcer Pericarditis or pericardial fluid Current use of anticoagulant Recent GI or GU bleed Age >75 years Diabetic retinopathy

70 What are we allowed to prescribe?

71 OHIO APN prescribing

72 Ohio APN formulary continued

73 Happy APN week!!! Cure sometimes, treat often, comfort always Hippocrates

74 Questions???

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