Understanding Risk Professor Dan Atar, MD, FESC Dept. of Cardiology Oslo University Hospital Oslo, Norway Vice-President of the ESC (2014-16) The GARFIELD Registry is funded by an unrestricted research grant from Bayer Pharma AG www.tri-london.ac.uk Professor Dan Atar: Disclosures • Co-author of 2010-2012 ESC Guidelines on Atrial Fibrillation • Steering Committee member, National Coordinator for Norway, and Co-author of ACTIVE, ARISTOTLE, AVERROES, GARFIELDAF, XANTUS, RE-ALIGN • Fees, honoraria from Sanofi-Aventis, Merck (MSD), Boehringer- Ingelheim, Bayer, BMS/Pfizer, Daiichi-Sankyo, Nycomed-Takeda European Heart Journal http://eurheartj.oxfordjournals.org/ A logical sequence to AF management ESC 2010 AF Guidelines Adapted from Gage BF et al. JAMA. 2001; 285:2864-2870. Courtesy Prof. R. de Caterina ESC 2010 AF Guidelines Since 2010, further validation of the CHA2DS2-VASc score Lip GY. J Thromb Haemost. 2011;9 Suppl 1:344–351. Potpara TS, et al. Circ Arrhythm Electrophysiol. 2012;5:319–326. Olesen JB, et al. Thromb Haemost. 2012;107:1172–1179. Van Staa TP, et al. J Thromb Haemost. 2011;9:39–48. Abu-Assi E, et al. Int J Cardiol. 2013;166:205–209. Recommendations for prevention of thromboembolism in non-valvular AF - general Recommendations Class The CHA2DS2-VASc score is recommended as a means of assessing stroke risk in non-valvular AF. I Level A Camm AJ, et al. Eur Heart J. 2012;33:2719–2747. Courtesy Prof. R. de Caterina ESC 2012 AF Guidelines update CHA2DS2-VASc score Patients (n=73538) Stroke and thromboembolism event rate at 1 year follow-up (%) 0 6369 0.78 1 8203 2.01 2 12771 3.71 3 17371 5.92 4 13887 9.27 5 8942 15.26 6 4244 19.74 7 1420 21.50 8 285 22.38 9 46 23.64 Adapted from Olesen JB, et al. Br Med J. 2011;342:doi: 10.1136/bmj.d124. The value of the CHA2DS2-VASc score for refining stroke risk stratification in patients with a CHADS2 score 0-1 Olesen et al Thromb Haemost. 2012 Jun;107(6):1172-9 Proportion of patients free of stroke/thromboembolism 100% 98% 96% CHA2DS2-VASc CHA2DS2-VASc CHA2DS2-VASc CHA2DS2-VASc CHADS2 = 0 94% 92% =0 =1 =2 =3 0% 0 100 200 300 Days from discharge In patients with a CHADS2=0, c-statistic was 0.573 (0.539–0.608) and increased to 0.641 (0.610–0.671) when CHA2DS2-VASc was included. www.escardio.org/guidelines European www.tri-london.ac.uk Heart Journal 2012 - doi:10.1093/eurheartj/ehs253 January CT, et al. Circulation. 2014;129:000-000. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society Craig T. January, L. Samuel Wann, Joseph S. Alpert, Hugh Calkins, Joseph C. Cleveland, Jr, Joaquin E. Cigarroa, Jamie B. Conti, Patrick T. Ellinor, Michael D. Ezekowitz, Michael E. Field, Katherine T. Murray, Ralph L. Sacco, William G. Stevenson, Patrick J. Tchou, Cynthia M. Tracy and Clyde W. Yancy Circulation. published online March 28, 2014; January, CT et al. Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 2014 AHA/ACC/HRS Atrial Fibrillation Guideline Copyright © 2014 American Heart Association, Inc. All rights reserved. Print ISSN: 0009-7322. Online ISSN: 1524-4539 2. Selection of antithrombotic therapy should be based on the risk of thromboembolism irrespective of whether the AF pattern is paroxysmal, persistent, or permanent (64-67). (Level of Evidence: B) 3. In patients with nonvalvular AF, the CHA2DS2-VASc score is recommended for assessment of The online version of this article, along with updated information and services, is located on the stroke risk (68-70). (Level of Evidence: B)Wide Web at: World 4. For patients withhttp://circ.ahajournals.org/content/early/2014/04/10/CIR.0000000000000040.citation AF who have mechanical heart valves, warfarin is recommended and the target international normalized ratio (INR) intensity (2.0 to 3.0 or 2.5 to 3.5) should be based on the type Data Supplement (unedited) at: B) and location of the prosthesis (71-73). (Level of Evidence: http://circ.ahajournals.org/content/suppl/2014/03/24/CIR.0000000000000040.DC1.html 5. For patients withhttp://circ.ahajournals.org/content/suppl/2014/03/24/CIR.0000000000000040.DC2.html nonvalvular AF with prior stroke, transient ischemic attack (TIA), or a http://circ.ahajournals.org/content/suppl/2014/04/10/CIR.0000000000000040.DC3.html CHA2DS2-VASc score of 2 or greater, oral anticoagulants are recommended. Options include: warfarin (INR 2.0 to 3.0) (68-70) (Level of Evidence: A), dabigatran (74) (Level of Evidence: B), rivaroxaban (75) (Level of Evidence: B), or apixaban (76). (Level of Evidence: B) January CT, et al. Circulation. 2014;129:000-000. 6. Among patients treated with warfarin, the INR should be determined at least weekly during initiation of antithrombotic therapy and at least monthly when anticoagulation (INR in range) is stable (77-79). (Level of Evidence: A) What do we know about risk in GARFIELD-AF? Stroke risk profile: CHADS2 / CHA2DS2-VASc Stroke risk profile: CHA2DS2-VASc Stroke risk profile: CHADS2 Percentage Percentage 34.7 33.4 15.7 23.7 19.5 21.9 12.3 10.7 2.2 0 8.8 7.1 6.5 1 2 3 4 5 0.4 6 3.3 0 1 2 3 4 5 6-9 Preliminary first year event rates according to number of risk factors No or 1 RF 2 RFs 3 RFs 4 RFs 5 or more RFs 6 5.4 Event rate (%) 5 4 2.8 3 2.2 2 1 1.8 1.5 1.5 0.9 0.9 0.5 0.4 0.8 1 2.1 1.1 0.5 0 Stroke/SE Major bleed Death RF, risk factor (heart failure, LVEF <40%, hypertension, age ≥75, diabetes, previous stroke/TIA/SE, vascular disease, age 65–74 years, female gender) Kakkar A, AHA-2012 Poster presentation at ESC • ‘Truly low-risk’ patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke: 1-year outcomes from the GARFIELD-AF Registry Jean-Pierre Bassand et al., for the GARFIELD-AF Investigators • Tuesday, 2 September from 14:00–18:00 in the poster area of the Central Village Rate of stroke/systemic embolism according to CHA2DS2-VASc score of 0 0.2% versus 1-9: 1.1% Conclusions • In patients with A-Fib, the estimation of individual risk of stroke is key before any therapeutic decision is made • CHA2DS2-VASc is recommended as the primary instrument in estimating risk of stroke (ESC 2012 / AHA+ACC 2014) • The focus is to identify truly low-risk patients – these will not need anticoagulation therapy • All other patients ought to receive anticoagulation for the indication of “SPAF” Thank you for your attention 17