VARFARIIN. Hüübimise taastamine verejooksu korral või eelseisvaks kirurgiaks. Hüübivuse taastamine Kasutusel erinevad ravimirühmad:
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- Letitia Todd
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1 Hüübimise taastamine verejooksu korral või eelseisvaks kirurgiaks Jaan Sütt SA TÜK EAS ja EKS ühisseminar Kasutusel erinevad ravimirühmad: Antikoagulandid: K-vitamiini antagonistid varfariin Otsesed trombiini inhibiitorid - dabigatraan Faktor Xa-inhibiitorid - rivaroksabaan, apiksabaan, edoksabaan jt Antiagregandid: ASA, klopidogreel jt Hepariinid: UFH LMWH Perioperatiivne käsitlus Epidemioloogia Perioperatiivne AK ravi katkestamine on sagedasti ette tulev probleem patsienti USA-s vajavad varfariinravi katkestamist protseduuride teostamiseks. Ca 10% AK tarvitajatest aastas. Healey JS et al. Circulation 2012;126:343; Douketis J et al. Chest 2008;133:399 RE-LY study (warfarin vs dabigatran for AF), n= % (4591) oli vähemalt üks AK ravi katkestus 2 aastase follow-up perioodi jooksul ROCKET AF ja ARISTOTLE uuringus AK ravi katkestus 1/3 patsientidest AF-i esinemissagedus populatsioonis on 1-2%, Haigekassa andmetel ca AF-i patsienti Eestis varfariini tarvitajat (2014) neist ca 1% tõsised verejooksud (ca 150 patsienti) AK ravi katkestusi ca 10% pt 4 Epidemioloogia Hüübivuse taastamine TÜK-is kodeeritud antikoagulandi üledoose (D68.4) 2014 aastal 28 korral, tegelikult rohkem Tartu EMO-s tehtud 2015.a PCC (Octaplex) 11 korral + osakonnad, OP Eestis 2014 kasutati PCC 40x (kood 4093) Rivaroxabani (Xarelto) 2015 kasutus Eestis oli 4 miljonit eurot (38 kg toimeainet) VARFARIIN 2016 prognoositav 6500 DOAC tarvitajat Eestis (ca 1000 Pradaxa) 2014 oli ca 1000 NOAC pt 5 1
2 Korrigeerimata INR-iga patsientide osakaal Plaaniline kirurgia Kõrge veritsusiskiga OP lõpeta varfariin 5 päeva enne OP-i (ACCP 1C soovitus) Optimaalne INR operatsiooniks või protseduuriks: Rahvusvahelised juhised < 1,5 INR kontroll OP eelsel päeval. Kui > 1,5, manustada K-vit 1-2,5 mg (ACCP soovitus) Intrakraniaalne kirurgia, tagumine silmakamber, regionaalanesteesia INR norm!!! Chest Feb;141(2 Suppl):e326S-50S. 7 VKA toime pööramise võimalused Vit K suukaudselt või i/v infusioonina i/m ja s/c ei soovitata hematoom!! mg??? Toime 6 (i/v) - 24 (p/o) tunni pärast VKP ülekanne ml/kg (70 kg ca 2 l plasmat) TACO - transfusion associated circulatory overload Protrombiini kompleksi kontsentraat (PCC) u/kg, kohene toime ACC/AHA 2014 Guidelines for the Management of Patients With Valvular Heart Disease The perioperative management of antithrombotic therapy, 9th Ed: ACCP guidelines; CHEST 2012 Veritsus VKA-ravi ajal i/v K-vitamiin PCC (VKP, kui PCC pole saadaval) K-vitamiin Intravenoosne Algväärtus Suukaudne VKP: värske külmutatud plasma; IV: intravenoosne; PCC: protrombiini kompleksi kontsentraat Keeling D jt. Br J Haematol 2011;154:311 24; Sarode R jt. Circulation 2013;128: ; Kaatz S jt. Am J Hematol 2012;87:S Lubetsky A jt. Arch Intern Med 2003;163: Protrombiini kompleksi kontsentraadid (PCC) Uuringuravimi infusiooni alustamisest möödunud tunnid 4F-PCC (N=98) Plasma (N=104) Suur verejooks: kiire toime pööramine u/kg PCC + 5 mg Vit K i/v (1B). FFP ei taga piisavat AK toime pööramist ja seda peaks kasutama vaid siis kui PCC pole kättesaadav (1C). Mitte-ohtlik verejooks: Antikoagulatsiooni pööramine 1-3 mg Vit K i/v (1B). INR >5 ja >8 ilma verejooksuta: Kui INR >5 jäta vahele 1 2 doosi varfariini ning vähenda säilitusdoosi (1B). Kõrge INR põhjus tuleb selgitada (sepsis?) (1C). Kui INR >8 anna 1 5 mg Vit K p/o (1B). Erakorraline kirurgia: Suure veritsusriskiga kirurgia tuleks võimalusel edasi lükata 6 12 t, INR korrigeerimiseks i/v Vit K. Kui ei saa edasi lükata > PCC + Vit K i/v. PCC-d ei peaks kasutama võimaldamaks koheselt läbi viia plaanilist või mitte-erakorralist kirurgiat (2C). Peavigastus: Kõigi peavigastustega patsientide INR tuleb mõõta esimesel võimalusel (1C). Pea CT uuring teostada vähimagi hemorraagia kahtluse korral (2C). Varfariinravil patsientide, kellel kahtlustatakse intratserebraalset verejooksu, antikoagulatsiooni peaks pöörama ootamata ära uuringute vastuseid (2C). Alates 2016 haigekassa hinnas muudatus: Koodiga 4093 tähistatud teenust osutatakse omandatud hüübimisteguri vaegusega patsiendile (RHK 10 kood D68.4) RHK 10 seisundite I60, I61, I62, S06, H43.1 korral või omandatud hüübimisteguri vaegusega hüübivuse kiireks taastamiseks erakorralise kirurgia või ( UUENDUS!) eluohtliku massiivse verejooksuga kulgeva seisundi korral või elupäästvate protseduuride (koodid 7741, 7709, 7746, 7744) teostamiseks tsentraalveeni kanüleerimine, erakorraline hemodialüüs/diafiltratsioon, pleuraõõne punktsioon/dreneerimine, perikardiõõne punktsioon/dreneerimine 2
3 Dabigatran Rivaroxaban Apixaban Edoxaban Toimemehanism Trombiin Faktor Xa Faktor Xa Faktor Xa Eelvorm Jah (dabigatraanetek silaat) Ei Ei Ei Biosaadavus (%) NOAC DOAC TSOAC ODI Toime maksimum (h) Poolestusaeg (h) Eliminatsioon neerude kaudu (%) Pharmacological properties of dabigatran, rivaroxaban, apixaban and edoxaban (from Yeh et al.) Standardseid hüübimisanalüüse saab kasutada dabigatraani toime hindamiseks kuid mitte teiste NOAC-de korral! Dabigatran Rivaroxaban Apixaban Plasma peak 2 h after ingestion 2 4 h after ingestion 1 4 h after ingestion Plasma trough h after ingestion h after ingestion h after ingestion aptt TT, dtt (quantitative) ECT Anti-FXa assays PT INR HÜÜBIMISE TAASTAMINE PLAANILINE KIRURGIA Time of last NOAC dose should always be considered when interpreting test results aptt, activated partial thromboplastin time; dtt, direct thrombin time; ECT, ecarin clotting time; FXa, Factor Xa; INR, international normalized ratio; PT, prothrombin time; TT, thrombin time Adapted from Heidbuchel H et al. Europace 2013;15:625 51; Pradaxa : EU SPC, 2014; Eliquis : EU SPC, 2014; Xarelto : EU SPC, 2014 Plaaniline kirurgia Millal anda viimane annus? NOAC ära jätta vastavalt tabelile Vaja teada neerufunktsiooni Sildamine pole üldjuhul vajalik kiire toime algus ja lõpp Millal uuesti alustada? Kiire toime algus (2t). Täisantikoagulatsioon! Erineb LMWH profülaktilisest doosist (nt. 0,5 mg/kg/ööp enoksapariin) mida võib alustada 6-8 t peale OP-i. Hemostaasi tingimustes (madal veritsusrisk) 6-8 t peale protseduuri (k.a. SSE) Keskmine või kõrge veritsusrisk alusta t peale OP-i Stop NOAC Väike veritsusrisk või kui on võimalik hea hemostaas (stomatol. protseduurid; glaukoomi, katarakti OP Vii protseduur läbi ravi katkestamata siis kui kontsentratsioon on madal (12-24t peale ravimi võtmist). Järgmine doos 6 tunni pärast (BID korral 1 doos vahele jätta). Stom: suuloputus TXA-ga. Madal veritsusrisk Norm neerufunktsiooni korral viimane NOAC 24t enne OP-i Kõrge veritsusrisk Norm neerufunktsiooni korral viimane NOAC 48t enne OP-i Neerufunktsiooni langus Viimane NOAC (Dabi 96) tundi enne OP-i 3
4 Perioperative management of oral direct thrombin inhibitors and factor Xa inhibitors - Uptodate Antikoagulant Neerufunktsioon ja doos Protseduuri ja viimase doosi vaheline aeg Kõrge veritsurisk Madal veritsusrisk Taasalustamine peale protseduuri Kõrge veritsusrisk Madal veritsusrisk CrCl >80 ml/min 2 päeva 1 päev Dabigatran CrCl >50 ml/min 2-3 päeva 1-2 päeva Rivaroxaban Apixaban CrCl ml/min 4-5 päeva 2-3 päeva CrCl >50 ml/min CrCl ml/min CrCl >50 ml/min CrCl ml/min 2-3 päeva (7p maksafn häirega) 1-2 päeva 2-3 päeva 1-2 päeva Taasalusta Taasalusta tundi peale tundi peale protseduuri protseduuri (2. 3. postop (1. postop päeval) päeval) VERITSEV PATSIENT ERAKORRALINE KIRURGIA Edoxaban CrCl ml/min CrCl ml/min 2-3 päeva 1-2 päeva Anamnees Milline antikoagulant? Millises annuses? Millal võeti viimane annus? Kaasnev tromotsüütide inhibiitor? Kuidas saavutada hemostaasi? Milline hüübimisanalüüs? EHRA praktilised juhised Peata NOAC manustamine Lükka OP edasi 12t, soovitavalt 24t viimase doosi manustamisest aptt, TT, PT. Normaalne TT välistab Dabigatraani toime! Kui OP ei ole võimalik edasi lükata: Kaalu NOAC toime pööramist Kui manustamisest möödas <2t > aktiivsüsi 30-50g PCC Praxbind EHRA praktilised juhendid Üledoosi korral: kui ei ole veritsust > vaata ja oota AEG on kõige odavam antidoot NOAC-ite t1/2 lühike (ca 12t). Verejooks peaks peatuma 12-24t jooksul. Mehaaniline/kirurgiline hemostaas Hemodünaamika toetamine infusioon, transfusioon Dabigatraanravi korral: - adekvaatse diureesi säilitamine - hemodialüüs HEMODIALÜÜS 4
5 Dialüüsi kasutamine dabigatraanravi korral Väike molekulmass (630 Da) 80% eritatakse muutumatul kujul uriiniga CrCl langedes t1/2 pikeneb Neerufunktsioon Norm CrCl ml/min CrCl<30 ml/min NP Keskmine t 1/ (h) Suur jaotusruumala, L Madal valkudega seotus, 26 28% NP, lõppstaadiumis neeruhaigus Uuringutes on näidatud, et HD eemaldab 62% dabigatraanist 2 tunni pikkuse seansi jooksul 68% 4 tunniga Oht veritsuse tekkele dialüüsisondi punktsionikohas Pradaxa EU SPC, 2014; Pradaxa US P 2014; Stangier J et al. Clin Pharmacokinet 2010;49: Heidbuchel H et al. Europace 2013;15: Kuidas HD läbi viia? Dabigatran a PTT Haemodialysis PCC Singh T et al. Clin J Am Soc Nephrol 2013;8: PCC NOAC toime pööramiseks PCC NOAC toime pööramiseks Ei ole kliinilisi uuringuid, mis näitaks, et verejooksuga haigetel PCC vähendaks verekaotust või parandaks outcome-i Tervetel vabatahtlikel tehtud uuring PCC algdoos 50 U/kg, vajadusel lisaannus 25 U/kg on efektiivne rivaroksabaani korral rfviia ei peaks kasutama esmajärjekorras TXA, DDAVP ei ole andmeid, et need aitaks NOAC-ite korral VKP, Vit K, protamiin ei aita Väldi hüpotermiat, atsidoosi, hüpokaltseemiat! Haiglas peaks olema VEREJOOKSU KÄSITLEMISE juhend! Dabigatraan Rivaroksabaan Reversal of Rivaroxaban and Dabigatran by Prothrombin Complex Concentrate, Eerenberg et al.,circulation.2011;124:
6 Masotti L 1, et al. J Thromb Thrombolysis May;39(4): Management of new oral anticoagulants related life threatening or major bleedings in real life: a brief report. NOAC toime pööramiseks Summary: Rapid reversal of coagulopathy following administration of a 4-factor PCC was reported in a dabigatran-treated elderly patient presenting with severe gastrointestinal haemorrhage [65]. In a patient with lifethreatening rectal bleeding on dabigatran treatment, bleeding cessation was achieved after administration of two doses of 4-factor PCC, while coagulation parameters remained abnormal. Ei ole kliinilisi uuringuid, mis näitaks, et verejooksuga haigetel PCC vähendaks verekaotust või parandaks outcome-i Tervetel vabatahtlikel tehtud uuring PCC algdoos 50 U/kg, vajadusel lisaannus 25 U/kg. rfviia ei peaks kasutama esmajärjekorras TXA, DDAVP ei ole andmeid, et need aitaks NOAC-ite korral VKP, Vit K, protamiin ei aita Väldi hüpotermiat, atsidoosi, hüpokaltseemiat! Haiglas peaks olema VEREJOOKSU KÄSITLEMISE juhend! NOAC toimet pööravad ained: arenduse staadiumid Idarucizumab 1 Ta rget: dabigatran Phase I Phase II Phase III Patients: urgent surgery major bleeding; May ,3 Submitted for approval Feb 2015 US FDA approval 16 Oct EMA approval (EU) 20 Nov Andexanet alfa 1 Target: FXa inhibitors Phase I Phase II Phase III Patients: major bleeding; Jan Submitted for approval Dec 2015 PRAXBIND Ciraparantag 1 Target: universal Phase I Phase II Ongoing 7 1. Adapted from Greinacher A et al. Thromb Haemost 2015; 2. Pollack C et al. N Engl J Med 2015; 3. Pollack CV et al. Thromb Haemost. 2015; 4. FDA ClinicalTrials.gov Identifier: NCT ; 6. ClinicalTrials.gov Identifier: NCT Trombiin, Dabigatraan, Idarutsizumab Idarutsizumab Humaniseeritud Fab fragment ~350 afiinsem dabigatraanile kui trombiin Dabigatraan ~500 daltonit Dabigatraan IV manustamine, kohene toime algus Lühike poolestusaeg (ca 6t) Trombiin ~36000 daltonit Idarutsizumab ~47800 daltonit Idarutsizumab Ei oma pro- või antikoagulantset toimet Pollack CV et al. Thromb Haemost 2015 Schiele F et al. Blood 2013; Stangier J et al. ISTH 2015, OR320 6
7 dtt (s) Idarucizumab RE-VERSE AD RE-VERSE AD uuringu vaheanalüüs 90 patsiendil Grupp A: Kontrollimatu verejooks + dabigatran-ravi Grupp B: Vältimatu kirurgia või protseduur + dabigatran-ravi 5 g idarucizumab (2 eraldi infusiooni 2.5 g) 0 15 min 90 days follow-up N= tundi NEJM Esimene prospektiivne idarutsizumabi uuring patsientidel Hospitaliseerimine min 4 h 90 d Esmane tulemusnäitaja: Dabigatraani toime pööramine 4 tunni jooksul (dtt või ECT) *dtt, diluted thrombin time; ECT, ecarin clotting time 1. Pollack CV et al. Thromb Haemost 2015; 2. ClinicalTrials.gov Identifier: NCT Tulemused grupp A ja B koos (dtt) Grupp A (kontrollimatu verejooks) ja B (erakorraline kirurgia või protseduur) koos Assay upper 100 limit of normal Idarutsizumab g Uuringu kokkuvõte Idatutsizumabi manustamine tagas: Kohese dabigatraani toime peatamise, mis oli ka täielik (100%) va 1 patsiendil, ja püsis üle 12 tunni 90% patsientidest Grupis A ja 81% patsientidest Grupis B Teisesed tulemusnäitajad: Keskmine verejooksu peatumise aeg Grupis A oli vähem kui 12 tundi Grupis B saavutati normaalne operatsiooniaegne hemostaas 92% patsientidest (33/36) Baseline Between h 2 h 4 h 12 h 24 h vials min Time post-idarucizumab Vaheanalüüs esimese 90 patsiendi andmete põhjal 1. Vaheanalüüs esimese 90 patsiendi andmete põhjal 1. Pollack CV et al. N Engl J Med 2015 Idarutsizumab (Praxbind) Näidustused: kõik dabigatraaniga antikoaguleeritud patsiendid, kellel esineb: eluohtlik verejooks või verejooks elutähtsatesse organitesse (silm, aju, ), verekaotus >20% voluumenist või transfusioonivajadus, vältimatu operatsiooni teostamise vajadus kõrge veritsusriski korral (ka profülaktiliselt). Näidustuste hulka ei kuulu: väiksem veritsus dabigatraanravi foonil, erakorraline operatsioon madala veritsusriski korral, plaaniline kirurgia, dabigatraani üledoos veritsuse puudumise korral. 7
8 JUHISED ANTIAGREGANTRAVI 8
9 Enne op-i lõpetada õigeaegselt NSAID-id Antiagregantravi NSAID-id inhibeerivad pöörduvalt trombotsüütide vahendatud tsüklooksügenaasi aktiivsust. Enne op-i tuleb lõpetada ajal, mis korreleerub 5 eliminatsiooni poolväärtusajaga Lühikese toimeajaga 2-6 t, lõpetada 1 päev enne op-i: ibuprofeen, diklofenak, ketoprofeen, indometatsiin Mõõduka toimeajaga 7-15 t, tuleb lõpetada 2-3 päeva enne op-i: naprokseen, sulindac, diflunisal Pika poolväärtusajaga >20 t, lõpetada enne op-i 10 päeva: meloksikaam, piroksikaam, nabumetoon ASA, clopidogreel, prasugreel häirivad trombotsüütide funktsiooni pöördumatult Ticagrelor pöörduv inhibitsioon Efekti möödumiseks on vajalik trombotsüütide uuenemine Täielik uuenemine 7-10 päeva, iga päev vahetub 10%, 5 päeva möödudes on funktsioneerivaid trombotsüüte piisavas koguses Antiagregantravi ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management. ESC Clinical Practice Guidelines 2014 Aspiriin: POISE-2 study Aspiriini grupis ei olnud letaalsust või MI vähem. ASA peaks lõpetama kui veritsusrisk on kõrgem kui eeldatav kasu c/v süsteemile. Selja-, neurokirurgia, osa silmakirurgiat ASA lõpetada vähemalt 7 päeva varem. Kaksikravi: 5-25% stentidega haigetest vajab 5 a jooksul kirurgiat Kaksikravi katkestamise korral kirurgiaks nädalate jooksul peale stentimist kasvas suremus 20%! KaluzaGL,.Catastrophic outcomes of non cardiac surgery soon after coronary stenting JAmCollCardiol2000;35: BMS. DAPT min 1 kuu. Lükka OP edasi min 1 kuu, soov 4 kuud peale stentimist. Võimaluisel jätka ASA. DES. DAPT min 3 kuud. Angio juurdepääs vajalik 24/7! Bridging tirofiban Antiagregantravi toime KIIRE pööramine PLT ülekanne! Hepariinid Hepariinide toime neutraliseerimine UFH katkesta infusioon, i/v protamiin, 1mg neutraliseerib 100 TÜ UFH Doos: kalkuleeri hepariini annuse järgi või manusta pimesi mg protamiini ja kontrolli APTT LMWH Protamiin toimib osaliselt, ei pööra kogu anti-xa aktiivsust, neutraliseerib suurema mol massiga LMWH fraktsioonid Täisannus protamiin sulfaati antakse kui LMWH manustatud <8 tundi, võib kasutada väiksemat annust kui aeg > 8 tunni. Kui veritsus jätkub võib teha korduva süsti pool esimesest annusest Enoksapariin - 1 mg protamiini 1 mg of enoxapariini kohta Daltepariin - 1 mg protamiini neutraliseerib 100 anti Xa ühikut. Kui ikka veritseb kaalu rfviia Tänan tähelepanu eest! 9
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