La gestione dell anticoagulazione orale
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- Derrick Johns
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1 La gestione dell anticoagulazione orale Armando D Angelo Servizio di Coagulazione & Unità Ricerca Trombosi IRCCS Ospedale San Raffaele, Milano, Italia 1 Corso SISET Cremona 20 settembre 2016
2 Warfarin
3 Narrow thrapeutic range 80 Target INR ( ) Ischaemic stroke Intracranial haemorrhage The anticoagulant effect of vitamin K antagonists are optimized when therapeutic doses are maintained within a very narrow range 0 < >4.5
4 Warfarin
5 New oral anticoagulants Rivaroxaban Apixaban Edoxaban Dabigatran
6 Non valvular atrial fibrillation Dabi LD Dabi HD Riva SD Apix SD Edox LD Edox HD Stroke/SE ni* -33% ni -20% ni ni * Non inferior; -21% on treatment
7 Non valvular atrial fibrillation Dabi LD Dabi HD Riva SD Apix SD Edox LD Edox HD Stroke/SE ni* -33% ni -20% ni ni Non hemorrh. stroke ni -23% ni ni +42% ni Hemorrhagic stroke -69% -74% -42% -49% -67% -46% * Non inferior; -21% on treatment
8 Non valvular atrial fibrillation Dabi LD Dabi HD Riva SD Apix SD Edox LD Edox HD Stroke/SE ni* -33% ni -20% ni ni Non hemorrh. stroke ni -23% ni ni +42% ni Hemorrhagic stroke -69% -74% -42% -49% -67% -46% Intracranial bleeding -69% -59% -34% -58% -69% -54% * Non inferior; -21% on treatment
9 Non valvular atrial fibrillation Dabi LD Dabi HD Riva SD Apix SD Edox LD Edox HD Stroke/SE ni* -33% ni -20% ni ni Non hemorrh. stroke ni -23% ni ni +42% ni Hemorrhagic stroke -69% -74% -42% -49% -67% -46% Intracranial bleeding -69% -59% -34% -58% -69% -54% Fatal bleeding -42% -27% -50% -38% -65% -45% * Non inferior; -21% on treatment
10 Non valvular atrial fibrillation Dabi LD Dabi HD Riva SD Apix SD Edox LD Edox HD Stroke/SE ni* -33% ni -20% ni ni Non hemorrh. stroke ni -23% ni ni +42% ni Hemorrhagic stroke -69% -74% -42% -49% -67% -46% Intracranial bleeding -69% -59% -34% -58% -69% -54% Fatal bleeding -42% -27% -50% -38% -65% -45% Vascular death ni -15% ni ni -15% -14% * Non inferior; -21% on treatment
11 Non valvular atrial fibrillation Dabi LD Dabi HD Riva SD Apix SD Edox LD Edox HD Stroke/SE ni* -33% ni -20% ni ni Non hemorrh. stroke ni -23% ni ni +42% ni Hemorrhagic stroke -69% -74% -42% -49% -67% -46% Intracranial bleeding -69% -59% -34% -58% -69% -54% Fatal bleeding -42% -27% -50% -38% -65% -45% Vascular death ni -15% ni ni -15% -14% All-cause death ni ni ni ni -13% ni * Non inferior; -21% on treatment; p = 0.051
12 Non valvular atrial fibrillation Dabi LD Dabi HD Riva SD Apix SD Edox LD Edox HD Stroke/SE ni* -33% ni -20% ni ni Non hemorrh. stroke ni -23% ni ni +42% ni Hemorrhagic stroke -69% -74% -42% -49% -67% -46% Intracranial bleeding -69% -59% -34% -58% -69% -54% Fatal bleeding -42% -27% -50% -38% -65% -45% Vascular death ni -15% ni ni -15% -14% All-cause death ni ni ni ni -13% ni * Non inferior; -21% on treatment; p = 0.051
13 Un confronto con i pazienti dei Centri Emostasi e Trombosi
14 Major bleeding complications DABI EDOX RIVA APIX LD HD LD HD SD SD % p-y % p-y % p-y % p-y % p-y % p-y Mean age (yrs) Major bleeding Intracranial bleeding Gastrointestinal bleeding Fatal bleeding
15 Major bleeding complications DABI EDOX RIVA APIX AVK LD HD LD HD SD SD Poli et al % p-y % p-y % p-y % p-y % p-y % p-y % p-y Mean age (yrs) Major bleeding Intracranial bleeding Gastrointestinal bleeding Fatal bleeding
16 Ma
17 Major bleeding complications
18 Perché meno emorragie intracraniche?
19 Proteine vitamina K-dipendenti Matrix Gla-protein ed osteocalcina Minor numero di emorragie cerebrali Osteoprosi
20 Vantaggi dei nuovi farmaci anticoagulanti orali Riduzione delle emorragie intracraniche Risparmio del sistema della proteina C Scompare la necrosi cutanea da AVK
21 Vantaggi dei nuovi farmaci anticoagulanti orali Riduzione delle emorragie intracraniche Risparmio del sistema della proteina C Scompare la necrosi cutanea da AVK Si riducono gli stroke cardioembolici ad inizio di trattamento?
22 Increased risk of stroke and of bleeding events on transitioning from Rivaroxaban or Apixaban to Warfarin HR for ischemic stroke/embolism HR for major bleeding events Rivaroxaban to W* Apixaban to W * less than 50% of patients had a therapeutic INR 30 days after last dose of rivaroxaban
23 This pattern mirrored the first 30 days of the trial where warfarin-naive patients starting warfarin had a higher rate of stroke or systemic embolism (5.41 % pat-y) than warfarin-experienced patients (1.41 % pat-y).
24 Azoulay L, et ai. Eur Heart J, December 18, 2013 Using the UK Clinical Practice Research Datalink, a nested case control analysis was conducted within a cohort of 70,766 patients with AF between 1993 and Stroke cases were randomly matched with up to 10 controls on age, sex, date of AF diagnosis, and time since AF diagnosis. Conditional logistic regression was used to estimate adjusted rate ratios (RRs) with 95% confidence intervals (CIs) of stroke associated with current warfarin use classified according to time since initiation of treatment (<30 days, days, and >90 days), when compared with non-use.
25 Azoulay L, et ai. Eur Heart J, December 18, 2013
26 Azoulay L, et ai. Eur Heart J, December 18, 2013
27 Azoulay L, et ai. Eur Heart J, December 18, 2013
28 Azoulay L, et ai. Eur Heart J, December 18, 2013 A total of 5519 patients experienced a stroke during follow-up. Warfarin was associated with a 71% increased risk of stroke in the first 30 days of use: RR: 1.71, 95% CI: ), while decreased risks were observed with initiation >30 days before the event days: RR: 0.50, 95% CI: >90 days: RR: 0.55, 95% CI:
29 INR (---) L inizio della terapia con VKA 5 warfarin TIME (hours)
30 INR (---) L inizio della terapia con VKA 5 warfarin F1+2, nmol/l ( ) TIME (hours)
31 FACTOR LEVELS, % L inizio della terapia con VKA 100 warfarin FII 25 FVII FX 0 TIME (hours)
32 FACTOR LEVELS, % L inizio della terapia con VKA 100 warfarin FII 25 PC 0 TIME (hours)
33 Azoulay L, et ai. Eur Heart J, December 18, 2013 Smooth cubic spline curve of the adjusted rate ratio of ischaemic stroke (solid line) and 95% confidence limits (dashed lines) as a function of the time since initiation of warfarin.
34 Azoulay L, et ai. Eur Heart J, December 18, 2013 Patients initiating warfarin may be at an increased risk of stroke during the first 30 days of treatment, supporting the biological plausibility of a transient hypercoagulable state at the start of the treatment, although additional studies are needed to confirm these findings.
35 FVII, % of baseline Warfarin treatment mg 10 mg 30, 20, 10 mg Time (days)
36 PC, % of baseline FVII, % of baseline Warfarin treatment mg 10 mg 30, 20, 10 mg Time (days) 5 mg 10 mg 30, 20, 10 mg Time (days)
37 PC, % of baseline FVII, % of baseline FX, % of baseline Warfarin treatment mg 10 mg 30, 20, 10 mg Time (days) 5 mg 10 mg 30, 20, 10 mg Time (days) mg 10 mg 30, 20, 10 mg Time (days)
38 PC, % of baseline FII, % of baseline FVII, % of baseline FX, % of baseline Warfarin treatment mg 10 mg 30, 20, 10 mg Time (days) mg 10 mg 30, 20, 10 mg Time (days) mg 10 mg 30, 20, 10 mg INR Time (days) Time (days)
39 D Angelo A, et al. Eur Heart J, January 15, 2014 The INR is a valid monitoring tool in patients on stable VKA treatment because it adjusts for the different sensitivity of thromboplastin reagents to the reduction in factor II, but this is not true at initiation of VKA treatment because of the much faster reduction in factor VII levels. Hence, the faster obtainment of "therapeutic" INRs with a loading dose is meaningless with respect to antithrombotic activity.
40 D Angelo A, et al. Eur Heart J, January 15, 2014 The INR is a valid monitoring tool in patients on stable VKA treatment because it adjusts for the different sensitivity of thromboplastin reagents to the reduction in factor II, but this is not true at initiation of VKA treatment because of the much faster reduction in factor VII levels. Hence, the faster obtainment of "therapeutic" INRs with a loading dose is meaningless with respect to antithrombotic activity. Based on data from patients with acute VTE - and heparin bridging -, the 2012 ACCP guidelines suggest (grade 2C) initiating therapy with warfarin 10 mg for the first two days rather than starting with the estimated maintenance dose.
41 D Angelo A, et al. Eur Heart J, January 15, 2014 The INR is a valid monitoring tool in patients on stable VKA treatment because it adjusts for the different sensitivity of thromboplastin reagents to the reduction in factor II, but this is not true at initiation of VKA treatment because of the much faster reduction in factor VII levels. Hence, the faster obtainment of "therapeutic" INRs with a loading dose is meaningless with respect to antithrombotic activity. Based on data from patients with acute VTE - and heparin bridging -, the 2012 ACCP guidelines suggest (grade 2C) initiating therapy with warfarin 10 mg for the first two days rather than starting with the estimated maintenance dose. The implication of a 2C suggestion is that higher-quality research may well change the estimate: isn't it time for a change?
42 D Angelo A, et al. Eur Heart J, January 15, 2014 The INR is a valid monitoring tool in patients on stable VKA treatment because it adjusts for the different sensitivity of thromboplastin reagents to the reduction in factor II, but this is not true at initiation of VKA treatment because of the much faster reduction in factor VII levels. Hence, the faster obtainment of "therapeutic" INRs with a loading dose is meaningless with respect to antithrombotic activity. Based on data from patients with acute VTE - and heparin bridging -, the 2012 ACCP guidelines suggest (grade 2C) initiating therapy with warfarin 10 mg for the first two days rather than starting with the estimated maintenance dose. The implication of a 2C suggestion is that higher-quality research may well change the estimate: isn't it time for a change?
43 Ostacoli potenziali ai nuovi farmaci Aderenza e persistenza senza monitoraggio di laboratorio
44 Ostacoli potenziali ai nuovi farmaci Osterberg L, Blaschke T. Adherence to medication NEJM 2005;353;487
45
46 Ostacoli potenziali ai nuovi farmaci Aderenza e persistenza senza monitoraggio di laboratorio Il paradigma dell ampio range terapeutico non è piuttosto solo ampia variabilità interindividuale?
47 Steady state trough plasma concentrations of DOACs (ng/ml) DOAC Dosaggio (mg) ng/ml (mediana) ng/ml (intervallo) Anti-Xa (UI) Anti-Xa (intervallo) Dabi 110 bid Dabi 150 bid Riva 20 sid Apix 2.5 bid Apix 5.0 bid Edox 30 sid Edox 60 sid percentile 5-95 percentile interquartile
48 Dabigatran trough concentrations, ng/ml (10-16 h after dosing) Reilly PA, et al. JACC 2014;63: % 3.8% 27.2% 69.0% Hemorrhagic stroke Major bleeding Any bleeding No bleeding
49 OR OR Reilly PA, et al. JACC 2014;63:321-8 Major Bleeding Stroke/SE
50 OR OR Reilly PA, et al. JACC 2014;63:321-8 Major Bleeding Stroke/SE
51 Reilly PA, et al. JACC 2014;63: year old male AF patient with diabetes and prior stroke (10th and 90th percentile)
52 Events / 1000 patient years Narrow therapeutic range with VKA in AF/VTE 80 Target INR ( ) Ischaemic stroke Intracranial haemorrhage The anticoagulant effect of vitamin K antagonists are optimized when therapeutic doses are maintained within a very narrow range 0 < > Hylek EM, et al. N Eng J Med 2003; 349: International Normalised Ratio (INR)
53 Perché non usare il laboratorio per valutare l attività anticoagulante dei dei nuovi farmaci e garantire maggiore sicurezza ai pazienti?
54 Migliorare efficacia e sicurezza?
55 Ruf et al, Lancet 2015
56 Non è difficile
57 DOA: QUALI TEST? FARMACO Dabigatran (ng/ml) Rivaroxaban (ng/ml) Apixaban (ng/ml) Edoxaban (ng/ml) DOSAGGIO DELL ATTIVITA ANTICOAGULANTE dtt ECT /ECA axa Pengo V et al, T&H 2011; Douxfils J et al, T&H 2012, 2013; Baglin T, JT&H 2013.
58 Tempo di trombina diluito, sec Concentrazione osservata, ng/ml Misurare la concentrazione plasmatica di dabigatran con il tempo di trombina diluito (mediana di concentrazione attesa a valle 91 ng/ml) % 4.9% % % % % 2.7% % % % 2.4% 5.0% Dabigatran, ng/ml Concentrazione attesa, ng/ml
59 mabs, 405 nm Concentrazione osservata, ng/ml Misurare la concentrazione plasmatica di rivaroxaban con il test anti-xa (mediana di concentrazione attesa a valle 32 ng/ml) % 2.3% 2.6% 2.9% 3.9% 4.4% Rivaroxaban, ng/ml Concentrazione attesa, ng/ml % 2.0% 1.8% 3.7% 5.7%
60 mabs, 405 nm Concentrazione osservata, ng/ml Misurare la concentrazione plasmatica di apixaban con il test anti-xa (mediana di concentrazione attesa a valle?) % 1.5% 1.7% 1.9% 1.8% 2.5% % 2.0% 1.4% 1.8% 1.4% 0.6% Apixaban, ng/ml Concentrazione attesa, ng/ml
61 Il rivedere i pazienti ad intervalli regolari, misurandone le concentrazioni di farmaco, costituisce anche un supporto educazionale importante per la loro aderenza/persistenza alla terapia anticoagulante
62 Anticoagulation clinics Hospital pharmacies Hemostasis and Thrombosis Centers (certified) Pharmacovigilance (AIFA, START registry) NOACS specific testing Research Pharmaceutical Companies Involvment of GPs in patient follow up Prescription of NOACS together with Specialists in Internal Medicine, Cardiology, Neurology, Hematology, Geriatrics
63 Idarucizumab Original Article Idarucizumab for Dabigatran Reversal Charles V. Pollack, Jr., M.D., Paul A. Reilly, Ph.D., John Eikelboom, M.B., B.S., Stephan Glund, Ph.D., Peter Verhamme, M.D., Richard A. Bernstein, M.D., Ph.D., Robert Dubiel, Pharm.D., Menno V. Huisman, M.D., Ph.D., Elaine M. Hylek, M.D., Pieter W. Kamphuisen, M.D., Ph.D., Jörg Kreuzer, M.D., Jerrold H. Levy, M.D., Frank W. Sellke, M.D., Joachim Stangier, Ph.D., Thorsten Steiner, M.D., M.M.E., Bushi Wang, Ph.D., Chak-Wah Kam, M.D., and Jeffrey I. Weitz, M.D. N Engl J Med 1915; 373:
64 Idarucizumab Clinical characteristics of patients
65 Idarucizumab Clinical characteristics of patients
66 Idarucizumab Clinical characteristics of patients
67 Idarucizumab Clinical characteristics of patients
68 Idarucizumab Clinical characteristics of patients
69 Idarucizumab Clinical characteristics of patients
70 Idarucizumab Time Courses of Plasma Concentrations of Unbound Dabigatran and Idarucizumab before and after the Administration of Idarucizumab.
71 Idarucizumab Time Course of the Dilute Thrombin Time and Ecarin Clotting Time before and after the Administration of Idarucizumab..
72 Idarucizumab Intravenous idarucizumab, an antibody fragment of a human antibody specific for dabigatran, produced rapid reversal of the anticoagulant effect in patients with bleeding or an urgent surgical indication with no apparent toxic effects or rebound hypercoagulable state.
73 Idarucizumab Idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes.
74 Idarucizumab Serious Adverse Events Leading to Death..
75 Idarucizumab Serious Adverse Events Leading to Death..
76 Andexanet N Engl J Med 2016; 30 Aug
77 Andexanet Characteristics of the Patients at Baseline.
78 Andexanet Characteristics of the Patients at Baseline.
79 Andexanet Characteristics of the Patients at Baseline.
80 Andexanet Characteristics of the Patients at Baseline. Of the 10% of patients with the highest anti factor Xa activity at the end of the infusion, 4 had received rivaroxaban and 1 had received apixaban; all received the lower dose of andexanet. The median values for anti factor Xa activity in these patients were ng per milliliter (interquartile range, to 505.8) at baseline
81 Andexanet Characteristics of Acute Major Bleeding Episodes and Clinical Outcomes.
82 Andexanet Characteristics of Acute Major Bleeding Episodes and Clinical Outcomes.
83 Andexanet Anti Factor Xa Activity and Percent Change from Baseline in Patients Receiving Rivaroxaban and Apixaban (Efficacy Population). Of the 10% of patients with the highest anti factor Xa activity at the end of the infusion, 4 had received rivaroxaban and 1 had received apixaban; all received the lower dose of andexanet. The median values for anti factor Xa activity in these patients were ng per milliliter (interquartile range, to 330.1) at the end of the infusion. All these patients were adjudicated as having excellent or good hemostasis.
84 Andexanet
85 Andexanet
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