1. www.tri-london.ac.uk The GARFIELD Registry is funded by an unrestricted research grant from Bayer Pharma AG Case discussion The patient caught between evidence and eminence… Sylvia Haas, MD, PhD Emeritus Professor Technical Univ. of Munich, Germany Steering Committee Member of GARFIELD

2. Disclosures Scientific Advisory Board member for Bayer Healthcare, sanofi-aventis, Bristol-Myers Squibb, CSL-Behring, Daiichi-Sankyo, ISIS, Sanofi Received honoraria from Bayer Healthcare, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer

3. GARFIELD inclusion criteria: –Newly diagnosed non-valvular AF and ≥1 additional investigator-defined risk factor for stroke –…

4. Mr. O.B., 64 y, newly diagnosed AF CHA 2 DS 2 -VASc Risk Factor Score Congestive heart failure/LV dysfunction 1 Hypertension1 Age > 752 Diabetes1 Stroke/TIA2 Vascular disease1 Age 65-741 Sex category (i.e. female)1 Maximum Score9

5. Mr. O.B., 64 y, newly diagnosed AF CHA 2 DS 2 -VASc Risk Factor ScoreScore Mr. O.B. Congestive heart failure/LV dysfunction10 Hypertension10 Age > 7520 Diabetes10 Stroke/TIA20 Vascular disease10 Age 65-7410 Sex category (i.e. female)10 Maximum Score90 Newly diagnosed non-valvular AF and ≥1 additional investigator-defined risk factor for stroke

6. Clinical pathways and atrial remodeling - Bridging obesity and AF Magnani JW, et al. Circulation 2013;128:401-405

7. GARFIELD (N=22,261) – Obesity BMI>30 Mr. O.B.* 189 cm 118 kg BMI 33 kg/m 2 Mr. O.B., 64 y, newly diagnosed AF * Cholesterol 290 mg/dl HDL 40 mg/dl LDL 167 mg/dl

8. Mr. O.B., 64 y, BMI 33 kg/m 2 The patient has been included in GARFIELD.  Would you prescribe anticoagulation therapy?

9. Mr. O.B., 64 y, BMI 33 kg/m 2 The investigator prescribed VKA, however it was difficult to keep the patient in the target range of INR 2.0 – 3.0 (FIR 60%) FIR=frequency in range (proportion of INR recordings in the therapeutic range)

10. Poster presentation - Tuesday 2 September 14:00–18:00 poster area of the Central Village “INR control and 1-year outcomes in patients with newly diagnosed AF: the GARFIELD Registry” Sylvia Haas et al., for the GARFIELD-AF Investigators Unadjusted 1-year outcomes in AF patients according FIR of INR measurements

11. The relationship between BMI and FIR is described by a reverse U-shaped curve with maximum value at about 30 kg/m 2. FIR increases as the BMI increases up to about 30 kg/m 2. For patients with BMI higher than 30 kg/m 2, FIR decreases as the BMI increases. Effect of BMI on FIR of INR

12. Some months later… Mr. O.B., 65 y, AF, BMI 33 kg/m 2 CHA 2 DS 2 -VASc Risk Factor ScoreScore Mr. O.B. Congestive heart failure/LV dysfunction10 Hypertension11 Age > 7520 Diabetes11 Stroke/TIA20 Vascular disease10 Age 65-7411 Sex category (i.e. female)10 Total Score93

13. GARFIELD – Obesity Mr. O.B., CHA 2 DS 2 -VASc 3  Would you convert the patient to a NOAC?

14. Mr. O.B., CHA 2 DS 2 -VASc 3 The patient has been converted to a NOAC  Would you monitor anticoagulation therapy in this patient?

15. Mr. O.B., CHA 2 DS 2 -VASc 3 The physician wants to monitor anticoagulation therapy in this patient  What guidance can we give?

16. Mr. O.B. CHA 2 DS 2 -VASc 3 + BMI 33 kg/m 2  If this patient was not anticoagulated and had ischaemic stroke + newly diagnosed AF, would you prescribe a NOAC for secondary prevention or try VKA first?

17. Mr. O.B. CHA 2 DS 2 -VASc 3 + BMI 33 kg/m 2  The patient suffered ischaemic stroke under NOAC  Which of the following options would you prefer for secondary prevention?

18. RCTs controlled double blind RCTs controlled Case control studies Case studies Animal research In vitro research Registries Real world Phase IV studies From evidence to eminence and back to evidence