ΠΟΙΟ ΑΝΤΙΠΗΚΤΙΚΟ ΓΙΑ ΤΟΝ ΑΣΘΕΝΗ ΜΟΥ? ΚΛΙΝΙΚΑ ΠΑΡΑΔΕΙΓΜΑΤΑ. Σωκράτης Παστρωμάς Καρδιολόγος Νοσοκομείο Ερρίκος Ντυνάν

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1 ΠΟΙΟ ΑΝΤΙΠΗΚΤΙΚΟ ΓΙΑ ΤΟΝ ΑΣΘΕΝΗ ΜΟΥ? ΚΛΙΝΙΚΑ ΠΑΡΑΔΕΙΓΜΑΤΑ Σωκράτης Παστρωμάς Καρδιολόγος Νοσοκομείο Ερρίκος Ντυνάν

2 The AF epidemic Mayo Clinic data (assuming a continued increase in the AF incidence) Mayo Clinic data (assuming no further increase in the AF incidence) ATRIA study data Circulation. 2006;114:119 25

3 Incidence and mortality AF is associated with a 5 fold higher stroke risk overall AF is responsible for 15% of all strokes, and AF is the leading cause of embolic stroke Stroke with AF is 50% fatal within 1 year (or severe diasability) Circulation. 2014;129: Ann Med 2007;39: Circulation 1998;98:946 52

4 Risk factor based point based scoring system CHA 2 DS 2 VASc EHJ. 2010;31:

5 Bleeding risk scores in AF J Am Coll Cardiol 2012;60:861 7

6 Prescription of VKAs in patients with AF Eur Heart J 2006; 27:

7 Country distribution of mean time in therapeutic range (TTR) in the RE LY trial Lancet 2010; 376:

8 Overall the warfarin users spent 63% of their time within therapeutic range (TTR) Patients with TTR at least 70% had a 79% reduced risk compared to patients with TTR 30% Thromb Haemost 2011;106:968 77

9 Key features of NOACs compared to VKA Clin. Cardiol. 2014;37:32 47

10 Phase III trials of NOACs Clin. Cardiol. 2014;37:32 47

11

12 NOACs

13 Secondary efficacy and safety outcomes warfarin vs. NOACs Major bleedings Lancet 2014; 383:

14 Which anticoagulant for which patient? Clinical scenarios 1. Chronic kidney disease (CKD) 2. High risk of bleeding (HASBLED 3) 3. Recent stroke or TIA (secondary prevention) 4. Coronary artery disease/pci 5. Interrupting therapy/planned procedure 6. Cardioversion

15 1. Patient with CKD Dabigatran Rivaroxaban Apixaban CrCl<30 ml/min: contraindication (EMA) CrCl ml/min: reduce dose to 75 mg bid (FDA) CrCl ml/min: 15 mg od instead of 20 mg CrCl<15 ml/min: Contraindication CrCl ml/min: 2.5 mg bid (or age>80 years, body weight 60 kg, serum Cr 1.5 mg/dl) Patients with CrCl ml/min & HAS BLED 3 : 110 mg instead of 150 mg bid NOACs : reasonable choice for mild or moderate CKD Apixaban: lower rate of major bleeding compared to VKAs Dabigatran: may not be the first choice OAC in CKD stage III Periodically assess renal function and adjust therapy (especially for dabigatran) ESC Guidelines 2012 Europace 2013;15: AHA/ACC Guidelines 2014

16 2. High risk of bleeding Dabigatran bleeding risk & age (RE LY data) Eikelboom et al Circulation. 2011;123:

17 Major bleeding by treatment Major bleeding risk increased with age. No differences between rivaroxaban & warfarin in each age category ICH was lower with rivaroxaban DBP>90 mmhg, COPD, increased age, ASA, GI bleeding history: independently associated risk factors J Am Coll Cardiol 2014;63:

18 ARISTOTLE Apixaban vs. Warfarin N Engl J Med ;365:981 92

19 Api vs. Dabi 110&150, Riva Riva vs. Dabi 110&150, Api

20 3. Previous stroke (secondary prevention) RE LY study. Sub analysis in patients with previous stroke Similar stroke or systemic embolism episodes between dabigatran 150 mg (2.07% per year), dabigatran 110 mg (2.32%) and warfarin (2.78%) Diener HC, et al. Lancet Neurol. 2010;9: ROCKET AF sub analysis secondary stroke prevention Rivaroxaban similar efficacy compared to warfarin in patients with previous stroke or TIA (2.79% rivaroxaban vs 2.96% warfarin, evnets per 100 person years) Hankey GJ,. Lancet Neurol. 2012;11: ARISTOTLE sub analysis secondary stroke prevention The rate of stroke was 2.46 per 100 patient years of follow up in the apixaban & 3.24 in the warfarin group ([HR] 0.76) Easton JD, Lancet Neurol. 2012;11:503 11

21 3. Previous stroke (secondary prevention) Indirect comparison analysis data Apixaban, rivaroxaban, and dabigatran have similar efficacy for secondary stroke prevention Haemorrhagic stroke, vascular death, major bleeding, and intracranial bleeding were less common with dabigatran 110 mg bid than with rivaroxaban

22 4. CAD/ Myocardial infarction/pci Clopidogrel plus VKAs vs. triple therapy: lower bleeding and mortality rates (WOEST trial) Apixaban 5mg bid plus antiplatelet therapy after ACS increased the number of bleedings without significant reduction in ischemic events (APPRAISE 2 trial) Lancet 2013; 381:

23 Low dose Rivaroxaban in patients with ACS Very low dose anticoagulation with rivaroxaban (2.5 mg BID), in addition to antiplatelet therapies, represents an effective strategy to reduce cardiovascular events in patients with a recent ACS BUT is not indicated for stroke prevention in AF

24 4. Coronary artery disease/pci Patients with AF and ACS (<1 year) Low or moderate atherothrombotic risk: VKA monotherapy after 1 3 months (or 6 months after DES) Patients with AF and ACS (>1 year) Patients with stable CAD: VKAs monotherapy because of the greater experience compared to NOACs High atherothrombotic risk and HAS BLED<3: plus antiplatelets (especially clopidogrel) DAPT without OACs in pts. with low CHA2DS2 VASc score and high atherothrombotic risk

25 5. Interrupting OAC therapy

26 6. Cardioversion Dabigatran: Stroke and major bleeding within 30 days of CV on the 2 doses of dabigatran were low and comparable to those on warfarin.(tee or not) Nagarakanti et al. Circulation. 2011;123: Rivaroxaban: The incidence of stroke or systemic embolism (1.88% vs. 1.86%) and death (1.88% vs. 3.73%) were similar in the rivaroxaban treated and warfarin treated groups.(rocket AF population) Piccini JP, et al. J Am Coll Cardiol. 2013;61: Apixaban: Major bleeding and cardiovascular events (no stroke) were rare and comparable between apixaban and warfarin within 30 days after CV (ARISTOTLE population) Flaker G at al. J Am Coll Cardiol. 2014;63:1082 7

27 NOACs selection based on indirect comparison data Savelieva I and Camm J. Clin. Cardiol. 37, (2014)

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