DOACs and real world data: What have we learned. Acute Stroke. George Ntaios University of Thessaly, Larissa

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1 DOACs and real world data: What have we learned that the RCTs have not told us? Acute Stroke George Ntaios University of Thessaly, Larissa

2 Disclosures Scholarships: European Stroke Organization; Hellenic Society of Atherosclerosis. Honoraria: Medtronic; Quintiles; CHUV; Belgian Stroke Council; Boehringer Ingelheim. Speaker fees: Sanofi; Boehringer Ingelheim; Galenica; Elpen; Bayer; Winmedica Support to attend conferences: Bayer; Sanofi Aventis; Pfizer; Lundbeck; Boehringer Ingelheim; Galenica; Elpen; Bristol Myers Squibb. Participation in trials: NAVIGATE ESUS / Steering Committee member, National Coordinator (Greece) & Principal Investigator (Larissa) PRECIOUS / National Coordinator (Greece) & Executive Committee member. ENOS / National Coordinator (Greece). FOURIER / Principal investigator (Larissa). GLORIA AF / Sub investigator (Larissa). EBBINGHAUS / Principal Investigator (Larissa). BIOSIGNAL / Principal Investigator (Larissa). PREVISE / Principal investigator (Larissa). RECOVERY / Principal investigator (Larissa)

3 Ischemic stroke in anticoagulated patient

4 Ischemic stroke in anticoagulated patient Ηλικία <18 ή >80 >4.5 ώρες από την έναρξη του ΑΕΕ Άγνωστη ώρα έναρξης του ΑΕΕ NIHSS <4 ή >25 Ραγδαία κλινική βελτίωση Ενδοκράνιoς αιμορραγία (CT ή MRI) Υπόπυκνη περιοχή >30% της κατανομής της μέσης εγκεφαλικής Πρόσφατο ΑΕΕ (<3 μήνες) Ιστορικό ΑΕΕ και συνύπαρξη Σ Βαριά συννοσηρότητα Αιμορραγική διάθεση Βαριά ηπατοπάθεια Προηγούμενο αιμορραγικό ΑΕΕ Υποψία υπαραχνοειδούς αιμορραγίας ΑΠ >185/110 παρά τη χορήγηση IV ανθυπερτασικών Αιμοπετάλια <100,000/mm 3 Λήψη LMWH ή per os αντιπηκτικών (INR >1.5, aptt >33sec) Υποψία διαχωριστικού ανευρύσματος αορτής Ένδο ή περικαρδίτιδα, παγκρεατίτιδα Πρόσφατο (<3 μήνες) χειρουργείο/αιμορραγία πεπτικού ή ουροποιητικού Σάκχαρο <50 ή >400mg/dl Ενδοκράνιος όγκος ή ανεύρυσμα Επιληπτική κρίση κατά το ΑΕΕ Πρόσφατη (<10 ημ.) ανάνηψη/παρακέντηση αρτηρίας ή οσφυονωτιαία

5 Ischemic stroke in VKA anticoagulated patient

6 Ischemic stroke in VKA anticoagulated patient

7 Ischemic stroke in VKA anticoagulated patient

8 Ischemic stroke in VKA anticoagulated patient INR: 1.6

9 Ischemic stroke in VKA anticoagulated patient Λήψη LMWH ή per os αντιπηκτικών (INR >1.5, aptt >33sec)

10 Ischemic stroke in NOAC anticoagulated patient European Cardiology Review 2015;10:76 8

11 Idarucizumab: an antidote for dabigatran Thrombin Dabigatran Idarucizumab

12 Idarucizumab: an antidote for dabigatran

13 Idarucizumab: an antidote for dabigatran dtt (s) Time after end of infusion (hours)

14 Andexanet: : an antidote for Xa inhibitors Siegal et al. NEJM2015

15 Andexanet: : an antidote for Xa inhibitors

16 Andexanet: : an antidote for Xa inhibitors Siegal et al. NEJM2016

17 Ciraparantag: : an antidote for all Ansell et al. NEJM2014

18 Ciraparantag: : an antidote for all Ansell et al. NEJM2014

19 Ischemic stroke in NOAC anticoagulated patient

20 Acute endovascular treatment thrombectomy

21 Anticoagulation after AF stroke: how soon (or late?)

22 Anticoagulation after AF stroke: how soon (or late?) Ntaios & Michel. Cerebrovasc Dis 2011

23 Anticoagulation after AF stroke: how soon (or late?) Reasons to start early Reasons to wait Low NIHSS Small/no brain infarction on MRI High recurrence risk e.g. thrombus on echo No haemorrhagic transformation Patient is clinically stable Young patient Blood pressure is controlled High NIHSS Large/moderate brain infarction Haemorrhagic transformation Neurologically unstable Elderly patient Uncontrolled hypertension

24 The rule TIA 1 day Small infarct 3 days Moderate infarct 6 days Large infarct 12 days

25 NOACs could be the answer? Ruff et al. Lancet 2013

26 Restart OAC after AF/OAC related ICH?

27 ESO ICH Guidelines Steiner et al. Int J Stroke. 2014

28 Restart OAC after AF/OAC related ICH Nielsen et al. Circulation 2015

29 Restart OAC after AF/OAC related ICH Nielsen et al. Circulation 2015

30 Restart OAC after AF/OAC related ICH Nielsen et al. Circulation 2015

31 Forget guidelines: we need to individualize

32 Bleeding vs. thromboembolic risk

33 Prognostic scores? Prognostic scores? HAS-BLED CHA2DS2-VASC2 CHADS2

34 Well, sorry.

35 Cerebral microbleeds

36 Cerebral microbleeds & ICH risk Charidimou et al. Stroke 2013

37 Cerebral microbleeds & ischemic stroke risk Charidimou et al. Stroke 2013

38 Forget guidelines: we need to individualize

39 NOAC vs. VKA: Intracranial haemorrhage Ruff et al. Lancet 2013

40 LAA occlusion? Holmes et al. JACC 2015

41 Talk & listen to your patients

42 Take home messages Stroke in anticoagulated patient? Restart antithrombotics after ICH? How soon OAC after IS?