Insights of the RE-LY CHA2DS2-VASc subgroup analysis Hisao Ogawa Kumamoto University, Japan CHA2DS2-VASc Risk factor score C Congestive heart failure/LV dysfunction 1 H Hypertension 1 A2 Age ≥75y 2 D Diabetes mellitus 1 S2 Stroke/TIA/TE 2 V Vascular disease (prior myocardial infarction, peripheral artery disease, or aortic plaque) 1 A Age 65-74y 1 Sc Sex category (ie female gender) 1 Maximum Score 9 maximum score is 9 since age may contrubute 0, 1, or 2 points Lip GY, et al., Chest 137, 263-272, 2010 CHA2DS2-VASc – overall event rates Stroke and systemic embolism %/year 6 5 4 3 2 1 0 CHA2DS2-VASc 0-1 2 3 4 5 6 7 8-9 No of patients 634 3408 5365 4378 2566 1185 451 125 CHA2DS2-VASc – overall event rates %/year 8 Major (including intracranial) bleeding Intracranial 7 Major 6 5 4 3 2 1 0 CHA2DS2-VASc 0-1 2 3 4 5 6 7 8-9 No of patients 634 3408 5365 4378 2566 1185 451 125 The Net Clinical Benefit of warfarin by CHADS2 score CHADS2 score 4-6 3 2.07 1.21 2 0.97 0.43 1 0 2.22 0.58 -0.27 -0.44 -1 0.19 -0.11 -0.5 Worse with Warfarin 0 3.75 2.79 1.41 0.45 -0.20 0.5 1 1.5 2 2.5 3 3.5 Better with Warfarin Singer DE, et al. : Ann Intern Med. 151, 297-305, 2009 Stroke and systemic embolism (SE) D110 BID vs. warfarin CHA2DS2-VASc D150 BID vs. warfarin Annual rate, % D110 D150 Warfarin ≤2 3 0.9 0.5 0.8 1.3 0.8 1.4 4 1.6 1.0 2.0 5-9 2.4 2.1 2.8 p(inter)=0.60 p(inter)=0.81 0.50 1.00 Dabigatran better 1.50 Warfarin better 0.50 1.00 Dabigatran better 1.50 Warfarin better Intracranial bleeding CHA2DS2-VASc ≤2 3 4 5-9 D110 BID vs. warfarin D150 BID vs. warfarin p(inter)=0.77 p(inter)=0.09 Annual rate, % D110 D150 Warfarin 0.15 0.16 0.11 0.32 0.38 0.76 0.29 0.32 0.21 0.63 1.04 0.84 0.50 1.00 Dabigatran better 1.50 Warfarin better 0.50 1.00 Dabigatran better 1.50 Warfarin better Conclusion Increasing CHA2DS2-VASc scores are associated with raised risks for stroke and bleeding, Irrespective of CHA2DS2-VASc scores dabigatran 150 mg was superior and dabigatran 110 mg non-inferior to warfarin for stroke prevention Both dabigatran doses reduce intracranial bleeding irrespective of CHA2DS2-VASc scores Dabigatran has a favorable benefit risk profile compared to warfarin in patients with low to high CHA2DS2-VASc scores
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