ΑΣΘΕΝΗΣ ΜΕ ΟΞΥ ΣΤΕΦΑΝΙΑΙΑΟ ΣΥΝΔΡΟΜΟ (ΟΣΣ) Ή PCI KAI KOΛΠΙΚΗ ΜΑΡΜΑΡΥΓΗ. ΠΡΟΛΗΨΗ ΘΡΟΜΒΟΕΜΒΟΛΙΚΟΥ ΚΙΝΔΥΝΟΥ

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1 ΑΣΘΕΝΗΣ ΜΕ ΟΞΥ ΣΤΕΦΑΝΙΑΙΑΟ ΣΥΝΔΡΟΜΟ (ΟΣΣ) Ή PCI KAI KOΛΠΙΚΗ ΜΑΡΜΑΡΥΓΗ. ΠΡΟΛΗΨΗ ΘΡΟΜΒΟΕΜΒΟΛΙΚΟΥ ΚΙΝΔΥΝΟΥ ΣΤΕΛΙΟΣ ΠΑΡΑΣΚΕΥΑÏΔΗΣ ΔΙΕΥΘΥΝΤΗΣ ΕΣΥ Α Καρδιολογική Κλινική ΑΠΘ, Νοσοκομείο ΑΧΕΠΑ, Θεσσαλονίκη

2 NO CONFLICT OF INTEREST

3 ΟΑC: Oral AntiCoagulant (Vitamin K Antagonists, NOAC) NOAC : Novel Oral AnticoAgulant (dabigatran, rivaroxaban, apixaban, edoxaban) ACS: Acute Coronary Syndrome CAD: Coronary Artery Disease PCI : Percutaneous Coronary Intervention Dual therapy: OAC or NOAC + 1 Antiplatelet Triple therapy: OAC or NOAC + 2 Antiplatelet DAPT: Dual Antiplatelet Therapy

4 CHA2DS2-VASc score (ESC ) score 2 score 1

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7 ΑΙΜΟΡΡΑΓΙΚΟΣ ΚΙΝΔΥΝΟΣ > 3 : high risk

8 ESC 2010

9 ESC 2012

10 NOACs- Mηχανισμός δράσης rivaroxaban, apixaban, edoxaban dabigatran

11 NOACs-ΦΑΡΜΑΚΟΚΙΝΗΤΙΚΗ 80% 35% 27% 50%

12 Lip GYH et al. Eur Heart J, August 2014 AF and ACS-PCI

13 Antithrombotic management in AF and ACS/PCI Low to intermediate (HAS-BLED=0-2) CHA2DS2-VASC=1 High (HAS-BLED >3 )

14 CHA2DS2-VASC > 2 Low to intermediate (HAS-BLED=0-2) High (HAS-BLED >3 )

15 Antithrombotic therapy in ACS/ PCI and AF consensus recommendations Triple therapy period : as short as possible followed by Dual therapy OAC plus a single antiplatelet therapy (preferably clopidogrel 75 mg/day, or aspirin mg/day) The duration of triple therapy is dependent : acute vs elective procedures bleeding risk (as assessed by the HAS-BLED score) type of stent (with a preference for new generation DES or BMS). OAC: well-controlled adjusted dose VKA (with TTR 70%) or NOAC.

16 TTR (Time in the Therapeutic Range of INR) target of TTR > 70 % (ESC anticoagulation working group position document)

17 SAME-TT2R2 score Sex (female), Age ( < 60 years), Medical history (at least two of the following: hypertension, diabetes, coronary artery disease, peripheral arterial disease, congestive heart failure, previous stroke, pulmonary disease, hepatic or renal disease) Treatment (interacting drugs, e.g. amiodarone for rhythm control). All one point Tobacco use and Race (non-caucasian). Two points score 0 1: VKA (warfarin) score 2 : NOAC De Caterina R et al. Thromb Haemost 2013;110:

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20 ΝΟACs-ACS dabigatran, rivaroxaban, apixaban, edoxaban

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23 dual therapy > 1 year

24 Stable Coronary Artery Disease

25 NSTEMI-Unstable Angina

26 NSTEMI-Unstable Angina

27 NSTEMI-Unstable Angina

28 OAC NOAC and PCI. «γέφυρα» με ηπαρίνηενοξαπαρίνη συνοδεύεται με αυξημένο αιμορραγικό κίνδυνο πιθανώς λόγω διπλής αντιπηκτικής δράσης στην μεταβατική περίοδο

29 NSTEMI-Unstable Angina-STEMI

30 STEMI AND AF Primary PCI (radial access, Class I, level of evidence A), aspirin, clopidogrel, and heparin (UFH) or bivalirudin Temporarily stop OAC, NOAC therapy No routine use of GP IIb/IIIa inhibitors or ticagrelor or prasugrel (Class IIb, level of evidence B) Ιn HAS-BLED score: 0 2 triple therapy (OAC, aspirin, and clopidogrel) should be considered for 6 months following PCI irrespective of stent type

31 STEMI IN AF under NOACs

32 WOEST study (What is the Optimal antiplatelet and anticoagulant therapy in pts with oral anticoagulation and coronary StenTing) n=573, F/U: 1 year Dual therapy (VKA plus clopidogrel) or Triple therapy (VKA plus aspirin and clopidogrel) after coronary stenting Dual therapy: 50% less total bleeding complications (without significant differences in major bleeds), with no detectable increase in the rate of thrombotic events, especially stent thrombosis. significant reduction in mortality at 12 months with dual therapy. Dewilde WJ, et al. Lancet 2013;381:

33 Ongoing randomized controlled trials (OAC-VKA) ISAR-TRIPLE (Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation (clopidogrel 75 mg for 6 weeks, aspirin and OAC) following implantation of a DES : composite end-point of death, MI, definite stent thrombosis, stroke, or major bleeding at 9 months. MUSICA-2 (Anticoagulation in Stent Intervention), Triple therapy of acenocoumarol, low-dose (100 mg) aspirin and clopidogrel vs. high-dose (300 mg ) aspirin and clopidogrel in patients with AF and low-to-moderate risk of stroke (CHADS2 2) referred for PCI. LASER (Real Life Antithrombotic Stent Evaluation Registry)

34 Ongoing trials-noac in PCI and AF PIONEER AF-PCI trial rivaroxaban (2.5 mg b.i.d. followed by 15 mg q.d. or 10 mg q.d. in subjects with moderate renal impairment) in comparison with a dose-adjusted VKA treatment strategy in AF and PCI. All pts will receive either single or dual antiplatelet therapy. This trial will also study the prasugrel and ticagrelor in combination with OAC. RE-DUAL PCI dabigatran (110 or 150 mg) + single antiplatelet vs - Warfarin + dual antiplatelet

35 n=30866 In pts with a recent ACS the addition of a NOAC to antiplatelet therapy results in a modest (30%) reduction in cardiovascular events but a substantial increase in bleeding, most pronounced (double) when NOACs are combined with dual antiplatelet therapy Oldgren J, et al. EHJ 2013;341:

36 DABIGATRAN antidote Idarucizumab is a fully humanized antibody fragment, or Fab, being investigated as a specific antidote for dabigatran with no other expected interactions A global phase III study, RE-VERSE AD is underway in patients taking PRADAXA who have uncontrolled bleeding or require emergency surgery or procedures (NCT )

37 RIVAROXABAN, APIXABAN, EDOXABAN Andidotes Andexanet alfa: F Xa Inhibitor Antidote First-in-class recombinant, modified Factor Xa molecule that is being developed as a direct reversal agent (antidote) for patients receiving a Factor Xa inhibitor who suffer a major bleeding episode or who may require emergency surgery Phase 3 studies ANNEXA- A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of F Xa Inhibitors Apixaban) ANNEXA- R (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of F Xa Inhibitors Rivaroxaban), in healthy volunteers are ongoing. ANNEXA- E (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of F Xa Inhibitors Edoxaban), is planned.

38 Συμπέρασματα H χορήγηση αντιθρομβωτικής αγωγής σε οξύ στεφανιαίο σύνδρομο ή PTCA με ΚΜ είναι συνάρτηση θρομβοεμβολικού κινδύνου CHA2DS2-VASc score αιμορραγικού κινδύνου HAS-BLED score επείγουσας ή μη παρέμβασης

39 Συμπέρασμα Η διάρκεια της τριπλής θεραπείας (αντιπηκτικά ΟΑC-NOAC και διπλή αντιαιμοπεταλιακή) η συντομότερη, ακολοθούμενη απο διπλή αγωγή (αντιπηκτικά ΟΑC-NOAC και κλοπιδογρέλη 75 mg ή ασπιρίνη mg) > έτος: μόνο αντιπηκτικά ΟΑC-NOAC Αναστολείς γλυκοπρωτεϊνικών υποδοχέων, GP IIb/IIIa, ticagrelor ή prasugrel : να μη χρησιμοποιούνται μέχρι την εξαγωγή συμπερασμάτων απο μεγάλες μελέτες

40 ΕΥΧΑΡΙΣΤΩ ΓΙΑ ΤΗΝ ΠΡΟΣΟΧΗ ΣΑΣ