Retningslinjer for nye antikoagulanter ved atrieflimmer

Transcription

1 Retningslinjer for nye antikoagulanter ved atrieflimmer Professor Dan Atar Avd.leder / avd.overlege, kardiologisk avdeling Oslo Universitetssykehus Ullevål Dagens Medisin Arena ( )

2 Prof. Dan Atar Disclosures Co-author of ESC Guidelines on Atrial Fibrillation Steering Committee member, National Coordinator for Norway, and Co-author of ACTIVE, ARISTOTLE, AVERROES, ENGAGE-AF Fees, honoraria from Sanofi-Aventis, Boehringer- Ingelheim, Bayer, BMS/Pfizer, Daiichi-Sankyo, Nycomed-Takeda

3 European Heart Journal doi: /eurheartj/ehs focussed update of the ESC Guidelines for the Management of Atrial Fibrillation An update of the 2010 ESC Guidelines for the Management of Atrial Fibrillation Developed with the special contribution of the European Heart Rhythm Association Authors/Task Force Members: A. John Camm (Chairperson) (UK)*, Gregory Y. H. Lip (UK), Raffaele De Caterina (Italy), Irene Savelieva (UK), Dan Atar (Norway), Stephan H. Hohnloser (Germany), Gerhard Hindricks (Germany), Paulus Kirchhof (Germany/UK)

4 A logical sequence to AF management ESC 2010 AF Guidelines

5 Opportunistic Screening Recommendations for screening AF Recommendations Class a Level b Opportunistic screening for AF in patients 65 years of age using pulse-taking followed by an ECG is recommended to allow timely detection of AF. I B a Class of recommendation. b Level of evidence. AF = atrial fibrillation; LoE = level of evidence. European Heart Journal doi: /eurheartj/ehs253

6 A logical sequence to AF management ESC 2010 AF Guidelines

7 Adapted from Gage BF et al. JAMA 2001; 285:

8 Problems with the CHADS 2 score Moderate c-statistics (0.58) in the whole cohort to predict stroke Most subjects categorized as moderate risk (score=1) These subjects overall still appear to derive benefit from oral anticoagulants vs aspirin Also, the CHADS2 score does not include many stroke risk factors, and other stroke risk modifiers needed to be considered in a comprehensive stroke risk assessment

9 ESC 2010 AF Guidelines

10 ESC 2010 AF Guidelines

11 Since 2010, further validation of the CHA 2 DS 2 -VASc score Lip GY. J Thromb Haemost 2011;9 Suppl 1: Potpara TS, et al. Circ Arrhythm Electrophysiol 2012;5: Olesen JB, et al. Thromb Haemost 2012;107: Van Staa TP, et al. J Thromb Haemost 2011;9: Abu-Assi E, et al. Int J Cardiol European Heart Journal doi: /eurheartj/ehs253

12 Adapted from Olesen JB, et al., Br Med J 2011;342:doi: /bmj.d124 ESC 2012 AF Guidelines update

13 Proportion of patients free of stroke/thromboembolism The value of the CHA 2 DS 2 -VASc score for refining stroke risk stratification in patients with a CHADS 2 score % 98% 96% 94% 92% 0% Olesen et al Thromb Haemost Jun;107(6): CHA 2 DS 2 -VASc = 0 CHA 2 DS 2 -VASc = 1 CHA 2 DS 2 -VASc = 2 CHA 2 DS 2 -VASc = 3 CHADS 2 = Days from discharge In patients with a CHADS 2 =0, c-statistic was ( ) and increased to ( ) when CHA 2 DS 2 -VASc was included. European Heart Journal doi: /eurheartj/ehs253

14 ESC 2010 AF Guidelines

15 Figure 1 Choice of anticoagulant Atrial fibrillation Yes Valvular AF* Yes No (i.e. non-valvular AF) < 65 years and lone AF (including females) No Assess risk of stroke (CHA 2 DS 2 -VASc score) 0 1** 2 Oral anticoagulant therapy Assess bleeding risk (HAS-BLED score) Consider patient values and preferences No antithrombotic therapy NOAC VKA * Includes rheumatic valvular AF, hypertrophic cardiomyopathy, etc. ** Antiplatelet therapy with aspirin plus clopidogrel, or less effectively aspirin only, may be considered in patients who refuse any OAC. Colour: CHA 2 DS 2 -VASc score; green = 1, blue = 2, red = 2. Line: Solid: best option; Dashed: alternative option. If absolute contraindications to any OAC or anti-platelet therapy, left atrial appendage closure device can be considered. AF = atrial fibrillation; CHA 2 DS 2 -VASc = see text; HAS-BLED = see text; NOAC = novel anticoagulants; VKA = vitamin K antagonist.

16 Male or female! European Heart Journal doi: /eurheartj/ehs253

17 Anticoagulation Peri-cardioversion Recommendations for prevention of thromboembolism in nonvalvular AF peri-cardioversion Recommendations Class Level For patients with AF of 48 h duration, or when the duration of AF is unknown, OAC therapy (e.g. VKA with INR 2-3 or dabigatran) is recommended for 3 weeks prior to and for 4 weeks after cardioversion, regardless of the method (electrical or oral/i.v. pharmacological). In patients with risk factors for stroke or AF recurrence, OAC therapy, whether with dose-adjusted VKA (INR 2-3) or a NOAC, should be continued lifelong irrespective of the apparent maintenance of sinus rhythm following cardioversion. I I B B European Heart Journal doi: /eurheartj/ehs253

18 CONCLUSIONS from ESC Guideline: The ESC 2012 AF Guideline Update emphasizes the need for stroke risk assessment in AF Focus on identification of truly low-risk patients All others: Oral Anticoagulation (OAC) recommended OAC can be either Warfarin or NOAC The 2012 ESC guideline update encourages the use of NOAC in suitable patients after thorough identification of potential contra-indications European Heart Journal doi: /eurheartj/ehs253

19 OPPLEGG FOR DISKUSJON: Helseøkonomi: Sitat SLV : Sammenliknet med warfarin synes dabigatran a gi kostnadsbesparelser for samfunnet. Legemiddelkostnadene er betydelig høyere for dabigatran enn for warfarin, men dette oppveies av reduserte kostnader til INR-ma ling og besparelser knyttet til færre hjerneslag.

20 OPPLEGG FOR DISKUSJON: Kan man stole på studier? Vi må ha real-world data (I) Analysis of a VA database between and ,297 incident users of dabigatran, 33,548 incident users of warfarin 1 year follow-up for GI bleeds, MI, ischemic stroke, ICH Gatrointestinal bleeds N Person-years # of events HR (adjusted) 95 % CI Dabigatran 14,297 5, Warfarin 33,548 10, ref Myocardial infarction Dabigatran 14,297 5, Warfarin 33,548 10, ref Intracranial hemorrhage Dabigatran 14,297 5, Warfarin 33,548 10, ref Ischemic stroke Dabigatran 14,297 5, Warfarin 33,548 10, ref Thelus R, et al. Circulation 2012 (abstract AHA scientific sessions)

21 Dabigatran: real world data (II) FDA-initiated Sentinel project of drug surveillance inpatient diagnosis for intracranial and GI bleeding events associated with new use of dabigatran or warfarin October 19, 2010, to December 31, 2011 enrollment of patients with AF and new prescription of OAC Incidence rate (per 100,000 days of risk) ICH and GIB times higher for warfarin ICH times higher for warfarin GIB times higher for warfarin http//

22 Dyrkorn R et al.: Opphavsrett Tidsskrift for Den norske legeforening. Lastet ned fra OPPLEGG FOR DISKUSJON: Marevan behandling er blitt mye sikrere

23 OPPLEGG FOR DISKUSJON: Blødningsrisiko ved akutt kirurgi - vi MÅ ha antidot

24 Rates of Major Hemorrhage with Type of Surgery Healey J et al: Circulation. 2012;126:

25 Rates of Major Hemorrhage with Timing of Surgery (4037 patients) * * Healey J et al: Circulation. 2012;126:

26 OPPLEGG FOR DISKUSJON: Norge er best på marevan behandling studiene viser at det NOAC s fordeler forsvinner

27 Median of Patients TTR in Different Countries in ARISTOTLE

28 Primary endpoint by center TTR

29 Takk for oppmerksomheten 29