I NUOVI ANTICOAGULANTI ORALI

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1 AGGIORNAMENTI in CARDIOLOGIA I NUOVI ANTICOAGULANTI ORALI F. BELLANDI U.O.CARDIOLOGIA OSPEDALE DI PRATO

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3 NOVEL ORAL ANTICOAGULANTS RISK SCORE STRATIFICATION TRULY LOW RISK PATIENTS

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5 CHA 2 DS 2 -VASc vs CHADS 2 CHA 2 DS 2 -VASc = 0 CHADS 2 = 0 CHA 2 DS 2 -VASc = 1 CHA 2 DS 2 -VASc = 2 CHA 2 DS 2 -VASc = 3 CHA DS 2 2-VASc score Stroke/thromboembolism thromboembolism rates at 1-y 1 follow-up Olesen JB, et al 2012 Thromb Haemost

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7 I IIa IIb III In patients with a CHA2DS2-VASc score of 0 (i.e., aged <65 years with lone AF) who are at low risk, with none of the risk factors, no antithrombotic therapy is recommended I IIa IIb III Female patients who are aged <65 and have lone AF (but( still have a CHA2DS2-VASc score of 1 by virtue of their gender) are low risk and no antithrombotic therapy should be considered

8 CHA DS 2 2-VASc score Stroke/thromboembolism thromboembolism rates at 1-y 1 follow-up NOVEL ORAL ANTICOAGULANTS Olesen JB, et al 2012 Thromb Haemost

9 I IIa IIb III Antithrombotic therapy to prevent thromboembolism is recommended for all patients with AF, except in those patients (both male and female) who are at low risk (aged <65 years and lone AF), or with contraindications

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11 Connolly SJ, et al

12 I IIa IIb III When patients refuse the use of any OAC (whether VKAs or NOACs), antiplatelet therapy should be considered, using combination therapy with aspirin mg plus clopidogrel daily (where there is a low risk of bleeding) ) or less effectively aspirin mg daily. 75 mg daily

13 ACTIVE Investigators

14 I IIa IIb III The risk of major bleeding with antiplatelet therapy (with aspirin clopidogrel combination therapy and especially in the elderly also with aspirin monotherapy) should be considered as being similar to OAC

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16 I IIa IIb III The choice of antithrombotic therapy should be based upon the absolute risks of stroke/thromboembolism thromboembolism and bleeding and the net clinical benefit for a given patient

17 CHA 2 DS 2 -VASc score implementation NOVEL ORAL ANTICOAGULANTS

18 I IIa IIb III The CHA 2 DS 2 -VASc score is recommended as a means of assessing stroke risk in non- valvular AF

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20 70 aa + malattia coronarica 50 aa + diabete CHADS 2 = 0 CHADS 2 = 1 CHA 2 DS 2 -VASc = 3 CHA 2 DS 2 -VASc = 1

21 I IIa IIb III In patients with a CHA 2 DS 2 -VASc score of 1, OAC therapy with adjusted-dose VKA (INR 2 3); or a direct thrombin inhibitor (dabigatran); or an oral factor Xa inhibitor (e.g. rivaroxaban, apixaban). should be considered, based upon an assessment of the risk of bleeding complications and patient preferences

22 I IIa IIb III Assessment of the risk of bleeding is recommended when prescribing antithrombotic therapy (whether with VKA, NOAC, aspirin/clopidogrel clopidogrel,, or aspirin).

23 I IIa IIb III The HAS-BLED score should be considered as a calculation to assess bleeding risk, whereby a score a score 3 indicates high risk and some caution and regular review is needed, following the initiation of antithrombotic therapy, whether with OAC or antiplatelet therapy

24 I IIa IIb III Correctable risk factors for bleeding [e.g. uncontrolled blood pressure, labile INRs if the patient was on a VKA, concomitant drugs (aspirin, NSAIDs, etc.), alcohol, etc.] should be addressed

25 I IIa IIb III Use of the HAS-BLED score should be used to identify modifiable bleeding risks that need to be addressed, but should not be used on its own to exclude patients from OAC therapy

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27

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30 I IIa IIb III NOACs (dabigatran, rivaroxaban,, and apixaban) are not recommended in patients with severe renal impairment (CrCl<30 ml/min)

31 I IIa IIb III Baseline and subsequent regular assessment of renal function (by CrCl) is recommended in patients following initiation of any NOAC, which should be done annually but more frequently in those with moderate renal impairment where CrCl should be assessed 2 3 times per year

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36 HR:0.26 HR:0.59

37 Adapted from Hart R, et al Ann Intern Med 2007

38 a. Fang MC, et al Am J Med 2007

39 NOVEL ORAL ANTICOAGULANTS = EFFICACY SAFETY

40 rule Pts warfarin suitable 50% don't get on it

41 rule Pts warfarin suitable 50% percent of those who do get on it, stop it

42 rule Pts warfarin suitable At least 50% of those remaining are not in the therapeutic range

43 rule Pts warfarin suitable about 12.5% are correctly treated with warfarin

44 NOVEL ORAL ANTICOAGULANTS CHA DS 2 2-VASc score Stroke/thromboembolism thromboembolism rates at 1-y 1 follow-up

45 DABIGATRAN ALMENO UNA DELLE TRE CONDIZIONI: 1) score CHA 2 DS 2 VASc 1 con HAS-BLED > 3 2) paziente già in trattamento con un antagonista della vitamina K (coumadin o derivati) se il tempo trascorso nel range terapeutico (TTR) negli ultimi 6 mesi, è 70% 3) Il trattamento anticoagulante con antagonisti della vitamina K non è attuabile per difficoltà oggettive ad eseguire i controlli di INR (es( es: i pazienti che eseguono i prelievi domiciliari)

46 RIVAROXABAN Differenze con DABIGATRAN: 1) score CHA2DS2VASc > 3 con HAS-BLED > 3 2) paziente già in trattamento con un antagonista della vitamina K (coumadin o derivati) se il tempo trascorso nel range terapeutico (TTR) negli ultimi 6 mesi, è 60% 3) Prescrivibile solo per la FANV PERMANENTE mentre il Dabigatran per tutte le forme di FANV

47 Alterata funzionalità renale = creatinina > 2.3 mg/dl Alterata funzionalità epatica = bilirubina x 2 e/o transaminasi x 3

48 DABIGATRAN (Pradaxa) 150 mg 1 cps x 2/die RIVAROXABAN (Xarelto) 20 mg 1 cp/die MINORE RISCHIO EMORRAGICO a) Creatinina clearance > 50 ml/min b) Età < 75 aa c) Peso > 50 Kg DABIGATRAN (Pradaxa) 110 mg 1 cps x 2/die RIVAROXABAN (Xarelto) 15 mg 1 cp/die MAGGIORE RISCHIO EMORRAGICO a) Creatinina clearance > 30 e < 50 ml/min b) Età > 75 aa c) Peso < 50 Kg

49 Switching Patients From Warfarin to New Oral Anticoagulants WARFARIN HALF LIFE hours If the new agent is initiated too soon after discontinuing warfarin, the risk for bleeding increases due to an overlap of anticoagulation effect if initiation of the new agent is delayed, then the risk for thrombosis increases. THE TIMING OF INITIATION OF THE NEW AGENT IS VERY IMPORTANT to ensure safe and effective anticoagulation Dabigatran may be initiated when the INR is less than 2.3, which is based on the study protocol of RE-LY Rivaroxaban may be initiated when the INR is 3.0, based on the ROCKET AF study However, most clinicians would prefer the INR to be 2.5 and falling prior to commencing rivaroxaban

50 Switching Patients From New Oral Anticoagulants to Warfarin DELAYED ACTION WARFARIN HALF-LIFE LIFE NOACs OVERLAP PERIOD RENAL FUNCTION DECLINING RENAL FUNCTION, SHORTER OVERLAP PERIOD LONGER NOAC HALF-LIFE, LIFE, SHORTER OVERLAP PERIOD

51 Switching Patients From New Oral Anticoagulants to Warfarin OVERLAP PERIOD Calculated CrCL, ml/min > Dabigatran Day 3 Day 2 Day 1 Rivaroxaban Day 4 Day 3 Day 2 The longer overlap with rivaroxaban is justified by its half-life life being shorter than that of dabigatran It is important to note that both dabigatran and rivaroxaban may affect the INR; thus, for a reliable determination of INR, measuring should be performed at least 2 to 3 days after discontinuing the new oral agent.

52 Managing Oral Anticoagulants in the Perioperative Setting BLEEDING RISK OF SURGERY HALF-LIFE LIFE NOACs timing of discontinuation RENAL FUNCTION declining renal function, longer NOAC half-life risk for bleeding,, a longer life and a higher longer duration of interruption may be needed

53 Managing Oral Anticoagulants in the Perioperative Setting Renal Function (CrCL,, ml/min) Dabigatran > 80 > 50 to 80 > 30 to Rivaroxaban > 30 < 30 Half-Life (h, range) 13 (11-22) 15 (12-34) 18 (13-23) 27 (22-35) 12 (11-13) 13) Unknown Timing of Discontinuation After Last Dose Before Surgery Standard Risk for Bleeding a 24 h 24 h 2 d 4 d 24 h 2 d High Risk for Bleeding b a) Cardiac catheterization, colonoscopy without removal of large polyps, and uncomplicated laparoscopic procedures, such as cholecystectomy b) Major cardiac surgery, insertion of pacemakers or defibrillators (resulting from the risk for pocket hematoma), neurosurgery, large hernia surgery, s and major cancer/urologic/vascular surgery. 2 d 2 d 4 d 6 d 2 d 4 d

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55 Rivaroxaban and apixaban undergo partial metabolism in the liver via the CYP450 pathway (CYP3A4) All 3 agents are substrates of P-glycoprotein P transporter

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57 Recommendations for prevention of thromboembolism in non- valvular AF AF peri-cardioversion I IIa IIb III For patients with AF of 48 h duration,, or when the duration of AF is unknown,, OAC therapy (e.g. VKA with INR or dabigatran) is recommended for 3 weeks prior to and for 4 weeks after cardioversion, regardless of the method (electrical or oral/i.v. pharmacological)

58 Recommendations for LAA closure I IIa IIb III Interventional, percutaneous LAA closure may be considered in patients with a high stroke risk and contraindications for longterm oral anticoagulation

59 I IIa IIb III Antithrombotic therapy to prevent thromboembolism is recommended for all patients with AF, except in those patients (both male and female) who are at low risk (aged <65 years and lone AF), or with contraindications I IIa IIb III The choice of antithrombotic therapy should be based upon the absolute risks of stroke/thromboembolism thromboembolism and bleeding and the net clinical benefit for a given patient

60 I IIa IIb III In patients with a CHA 2 DS 2 -VASc score of 1, and in patients with a CHA 2 DS 2 -VASc score of 2 I IIa IIb III OAC therapy with: adjusted-dose VKA (INR 2 3); or a direct thrombin inhibitor (dabigatran); or an oral factor Xa inhibitor (e.g. rivaroxaban, apixaban). should be considered ( is recommended) I IIa IIb III Aspirin plus clopidogrel or less effectively aspirin when patients refuse the use of any OAC (whether( VKAs or NOACs), should be considered.

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