טיפול נוגד קרישה עדכן פרופ' מאזן אליאס מנהל מחלקה פנימית ג' מרכז רפואי העמק יועץ המטולוגי מחוז צפון

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1 טיפול נוגד קרישה עדכן פרופ' מאזן אליאס מנהל מחלקה פנימית ג' מרכז רפואי העמק יועץ המטולוגי מחוז צפון

2 נושאים לדיון קומדין יתרונות וחסרונות טיפול נוגד קרישה בפרפור פרוזדורים הסיכון לדימום טיפול נוגד קרישה ב- DVT ו- PE עדכון תרופות נוגדות קרישה חדשות

3 Classical anticoagulants Vitamin K antagonists (warfarin) Unfractionated heparin (heparin) Low-molecular-weight heparins (Enoxaparin - Clexane)

4 מנגנון הפעולה - קומדין אנטגוניסט של ויטמין K Vitamin K קו-פקטור הכרחי בקרבוקסילצית חומצה גלוטמית בפקטורי הקרישה II,VII, IX, X קו-פקטור הכרחי בקרבוקסילצית חומצה גלוטמית בפרוטאין C ופרוטאין S

5 Coumadin Advantages נספג מצוין ניסיון רב עם התרופה נטולת תופעות לוואי מלבד דימומים תרופה זולה (8 לחודש)

6 Coumadin Disadvantages האפקט המכסימלי ניכר אחרי 48 שעות ההשפעה ממשיכה 5 ימים נוספים רמתו מושפעת מוויטמין K בדיאטה אינטראקציה עם תרופות טווח טיפולי צר בדיקת INR לעתים קרובות מינון דומה השפעה שונה

7 תרופות המשפיעות על קומדין פינוי Resprim Flagyl Procor Cimetidine Losec Rifampin Tegretol Barbiturate

8 Procor & Coumadin השלוב השכיח ביותר Procor מעלה את פעילות הקומדין להוריד מינון ב- 25%

9 מצבים המשנים השפעת קומדין מוטציות גנטיות CYP-2C9 1-2 mg/week VKORC1 (Vit K Epoxide Reductase) 30 mg /day

10 התחלת טיפול להתחיל במנת העמסה? סכנת הדימום עולה מצב של קרישת יתר (פרוטאין S ו- C להתחיל 10 מג' יומיים ולבדוק INR יורדים מהר) להתחיל במינון קבוע מעל גיל 70 מינון מג'

11 INR Equation INR = ( Patient s PT in Seconds ) Mean Normal PT in Seconds ISI INR = International Normalized Ratio ISI = International Sensitivity Index

12 לשמור 2-3 INR בקומדין INR בין * החלפת מסתם מיטרלי * מאורע טרומבוטי על טיפול

13 Atrial Fibrillation פרפור פרוזדורים

14

15 קרישי דם בעליה שמאלית

16

17 Ischaemic stroke in AF likely to result in persistent disability or death Outcomes of first ischaemic stroke in high-risk patients with AF (n=597) 60 Proportion of patients (%) % 20% 0 Persisting disability Modified Rankin scale 2 Death Gladstone DJ et al. Stroke 2009;40: Sept 2012

18 פרפור פרוזדורים ושבץ מוחי הסיכון של שבץ מוחי בפרפור פרוזדורים הוא 5% לשנה יכול להגיע עד 15% לשנה פרפור גורם ל- 15% מכלל המאורעות המוחיים פרפור גורם ל- 30% מכלל המאורעות מעל גיל 80 ניתן למניעה נוגדי קרישה

19 פרפור פרוזדורים Lone Atrial Fibrillation הסיכון הוא %1 לשנה לשנה Coumadin הסיכון- %1.5 (מוריד ב- (%68 Aspirin מוריד ב- %44

20 Atrial Fibrillation למי לתת קומדין?

21 CHADS 2 Score

22 CHADS 2 Score Cardiac Heart Failure Hypertension Age > 75 Diabetes Mellitus Stroke

23 CHADS2 Score > 2 Coumadin Treatment

24 Guidelines for the management of AF European Society of Cardiology (ESC) Guidelines European Heart Journal 2010: 31,

25 CHA 2 DS 2 -VASc Score Congestive Heart Failure 1 Hypertension 1 Age > 75 2 Diabetes Mellitus 1 Stroke/TIA/Embolism 2 Vascular disease 1 Age Sex (female) 1

26 Adjusted Stroke rate according to CHA 2 DS 2 VASc Score Score Stroke (rate/year) 0% 1.3% 2.2% 3.2% 4.0% 6.7% 9.8% 9.6% 15.2%

27 TTR (Time Therapeutic Range) TTR טוב מעל 68-75% ממוצע הזמן בו החולה מאוזן 55% Stroke מעל 68% פחות TTR

28 Goals for anticoagulation therapy in AF Prevent ischaemic stroke Minimize haemorrhagic stroke (minimize risk of ICH) 28 Sept 2012

29 Risk of bleeding (Intra-cerebral) 0.3% annually (Control 0.1%) Doubled with dual therapy (0.6%) INR > 3 (3-4.5) Annual risk > 3%

30 Risk of bleeding האם לתת לחולה שדמם בעבר? האם לתת בחולה עם מחלת כבד? האם לתת לחולה הנוטה ליפול?

31 HAS-BLED HAS-BLED risk criteria Score Hypertension 1 Abnormal renal or liver function (1 point each) 1 or 2 Stroke 1 Bleeding 1 Labile INRs 1 Elderly (e.g. age >65 yrs) Drugs or alcohol (1 point each) INR = international normalized ratio 1 1 or 2 HAS-BLED total score N Number of bleeds Bleeds per 100 patient-yrs* *P value for trend = Pisters R et al. Chest. 2010;138: ; ESC guidelines: Camm J et al. Eur Heart J 2010;31: Aug 2012

32 HAS-BLED > 3 High risk some Caution Falls overstated Give coumadin

33 Coumadin After Cerebral Hemorrhage Oral Anticoagulants may be resumed 3-4 weeks Maintain INR lower range

34 שאלות כל כמה זמן לבדוק INR בחולה המקבל קומדין? האם לא מסוכן לתת לאנשים מבוגרים עם נפילות קומדין??PE או DVT זמן לתת טיפול בחולה עם לכמה מה לעשות עם 3.9 INR בחולה המאוזן על קומדין??Clexane להפסיק קומדין לפני פעולה? האם לתת מתי על איזה INR ניתן לנתח? מה לעשות עם חולה שיש לו 8.6 INR וללא דימום? האם להפסיק אספירין כשמתחילים קומדין? האם לתת זריקת Clexane מניעתית לפני טיסה ארוכה?

35 CHEST 2012

36

37

38 להתחיל מנת העמסה 10 מג' ליומיים רמת INR ובהתאם להמשיך INR פעמיים בשבוע בהתחלה INR מאוזן: פעם בשבוע, פעם בשבועיים, פעם בחודש..

39 בדיקה פעם ב- 3 חודשים

40

41

42 האם לא מסוכן לתת לחולה מבוגר הנופל קומדין?

43 נפילות 300 נפילות גורם לדימום מוחי 1

44

45 INR חולה מאוזן קבוע: לא לשנות מינון. לחזור על הבדיקה תוך שבוע חולה לא מאוזן להוריד מינון שבועי של קומדין ב- 10%

46 INR & No bleeding להפסיק קומדין לא לשלוח לחדר מיון K צורך בוויטמין אין

47

48 Bridging

49 Perioperative להפסיק קומדין 5 ימים לפני ניתוח לחדש את הטיפול שעות לאחר הפעולה 1.5 > INR ניתן לנתח אם

50 לא להפסיק קומדין לפני טיפולי שיניים לפני ניתוח קטרקט לפני פעולות עוריות קטנות

51 Clexane During interruption of Coumadin

52 Bridging מסתם מלאכותי בסיכון גבוה: כל מסתם מיטרלי, stroke בחצי שנה האחרונה CHADS 2 Score 5-6 פרוזדורים: פרפור Recent Stroke (3 months) Rheumatic heart Disease

53 Bridging VTE (DVT/PE) Recent (3 months) Severe thrombophilia (ATIII def., LAC..)

54 No Bridging Bileaflet Aortic Valve with no AF Atrial fibrillation CHADS 2 Score 0-2 VTE (DVT/PE) > 12 months

55

56 Duration

57 VTE Provoked Surgery Fracture Hormonal therapy Non - Provoked

58 VTE-Treatment Provoked 3 months Non-Provoked long term treatment

59

60 Coumadin & Aspirin &Plavix BMS חודש טיפול משולש 3 חודשים טיפול משולש DES ללא Stent שילוב של אספירין וקומדין IHD אוטם או ניתוח מעקפים לפני יותר משנה ניתן להפסיק אספירין

61

62 שאלות?

63 New oral anticoagulants Direct thrombin inhibitors Factor Xa inhibitors

64

65 Dabigatran (Pradaxa) Oral thrombin inhibitor Plasma half-life hours (twice daily) Elimination via renal excretion No need for INR monitoring (Fixed dose)

66

67 RE-LY Study patients with AF CHADS 2 Score >1 1/3 Dabigatran 110 mg x 2 1/3 Dabigatran 150 mg x 2 1/3 Warfarin

68 RELY Study - Results Dabigatran 110 mg Vs Warfarin Stroke & Embolism similar rate Less bleeding Dabigatran 150 mg Stroke & embolism lower rate Similar rate of bleeding

69

70

71

72 פרדקסה נכללת בסל הבריאות!! 2012: הרחבת מסגרת הכללה בסל הבריאות ללא מחלה מסתמית עם CHADS2 score שווה ל- 4 ומעלה חולי AF קריטריונים שאושרו בסל 2011: חולי AF שחוו שבץ או TIA בשנה החולפת בזמן טיפול בקומדין. חולי AF שערכי ה- INR שלהם עלו מעל 5 (באירועים נפרדים). לפחות פעמיים במהלך השנה החולפת 72

73 במי לא להחליף חולה עם בעיה מסתמית,MS) (MR חולה לאחר החלפת מסתם מכני חולה לאחר תסחיף ריאתי או DVT

74 התוויות נגד אי-ספיקת כליות CCT מתחת ל- 30 מ"ל לדקה מחלת כבד כרונית ALT מעל פי שניים מהנורמה

75 מינון Pradaxa 150 mg x 2

76 Dosing Recommended dose: 150 mg BID (Superior in the prevention of stroke/se vs warfarin, lower rates of ICB and Life-threatening bleeds) Patients who should receive the dose of 110 mg BID Patients aged 80 years Patients who receive verapamil concomitantly May also be considered for those at high risk of bleeding BID = twice daily Pradaxa : EU SmPC, 2012 Disclaimer: Dabigatran etexilate is now approved for clinical use in stroke prevention in atrial fibrillation in certain countries. Please check local prescribing information for further details 76 76

77 איך להעביר מקומדין? להתחיל Pradaxa כאשר 2> INR להפסיק קומדין 3-4 ימים לבדוק INR

78 Patients requiring surgery or invasive procedure CrCl (ml/min) Estimated half-life (hrs) High bleeding risk or major surgery Stop Pradaxa Standard risk 80 ~13 2 days before 24 hours before 50 <80 ~ days before 1-2 days before 30 <50 ~18 4 days before 2 3 days before (>48 hours) BID = twice daily; CrCl = creatinine clearance Pradaxa : EU SmPC,

79 ניתוח דחוף בחולה המקבל Pradaxa במידת האפשר להמתין לפחות 12 שעות ממתן המנה האחרונה aptt תקין, TT הרדמה כללית ולא הרדמה ספינלית

80 Management of bleeding Patient on NOAC presenting with bleeding Check haemodynamic status, basic coagulation tests, to assess anticoagulation effect (e.g. aptt for dabigatran, PT or anti-xa activity for rivaroxaban), renal function, etc Minor Delay next dose or discontinue treatment Moderate-to-severe Symptomatic/supportive treatment Mechanical compression Fluid replacement Blood transfusion Oral charcoal if recently ingested* Very severe Consider rfviia or PCC Charcoal filtration*/haemodialysis* *With dabigatran aptt = activated partial thromboplastin time; NOAC = novel oral anticoagulant: PCC = prothrombin complex concentrate; PT = prothrombin time; rvfvii = activated recombinant Factor VIIa Camm AJ et al. Eur Heart J doi: /eurheartj/ehs Aug 2012

81 Rivaroxaban (Xarelto) Oral Anti Xa

82 Rivaroxaban (Xarelto) Prevention of VTE Orthopedic surgery (Record program) Treatment of VTE Einstein studies Prevention of stroke in AF Rocket study

83 Oral Rivaroxaban for symptomatic DVT The EINSTEIN Investigators N Engl J Med 2010: December 23, 2010

84 Oral Rivaroxaban for Symptomatic Venous Thromboembolism N Engl J Med patients Simple & single-drug approach Rivaroxaban had non-inferior efficacy No need to start with Enoxaparin

85 Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation N Engl J Med ,264 patients Non-Valvular AF at increased risk for stroke Rivaroxaban was non-inferior to warfarin for prevention of stroke or systemic embolism Significant reductions in intracranial hemorrhage & fatal bleeding

86

87

88 Rivaroxaban-Advantages Oral therapy Immediate action Short half life No food & drug interactions No need of blood tests Fixed dose

89 Xarelto 10 mg מאושר לשימוש בארץ כטיפול מונע ל- VTE באורתופדיה בניתוחי החלפת פרק ירך וחלפת ברך

90 Rivaroxaban in AF Practical Issues

91 Dosing in patients with atrial fibrillation The recommended dose for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation is 20 mg once daily

92 Dosing in patients with renal impairment In patients with moderate (creatinine clearance ml/min) or severe (15-29 ml/min) renal impairment the recommended dose is 15 mg once daily Use is not recommended in patients with creatinine clearance < 15 ml/min

93 Converting from VKA to Xarelto VKA therapy should be stopped Xarelto should be initiated when INR is <3 (SPAF)

94 Perioperative Management If an invasive procedure or surgical intervention is required, Xarelto should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician If the procedure cannot be delayed the increased risk of bleeding should be assessed against the urgency of the intervention Xarelto should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established

95 לאחרונה Xarelto אושרו בסל לחולים עם פרפור פרוזדורים עם CHADS Score = or >4 Xarelto אושר לטיפול ב- DVT

96 Other New Anti-coagulants Apixaban (BMS) Edoxaban (Daiichi-Sankyo)

97 Choice of anticoagulant Atrial fibrillation Valvular AF* Yes Yes No (i.e. nonvalvular) <65 years and lone AF (including females) No Assess risk of stroke CHA 2 DS 2 -VASc score Oral anticoagulant therapy Assess bleeding risk (HAS-BLED score) Consider patient values and preferences No antithrombotic therapy NOAC VKA Antiplatelet therapy with ASA plus clopidogrel or less effectively ASA only, should be considered in patients who refuse any OAC or cannot tolerate anticoagulation for reasons unrelated to bleeding. If there are contraindications to OAC or antiplatelet therapy, left atrial appendage occlusion, closure or excision may be considered Colour CHA 2 DS 2 -VASc: green = 0, blue = 1, red 2; line: solid = best option; dashed = alternative option *Includes rheumatic valvular disease and prosthetic valves; ASA = acetylsalicylic acid; NOAC = novel oral anticoagulant; VKA = vitamin K antagonist Camm AJ et al. Eur Heart J doi: /eurheartj/ehs Aug 2012

98 לסיכום קומדין יתרונות וחסרונות טיפול נוגד קרישה בפרפור פרוזדורים הסיכון לדימום טיפול נוגד קרישה ב- DVT ו- PE תרופות נוגדות קרישה חדשות

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