Latest Frontiers in Anticoagulation Therapy Your key questions for 2018 clinical practice addressed Supported by an unrestricted educational grant from Course Director Prof. Saskia Middeldorp
Anticoagulation 2017: the key lessons and implications from recent trials John Eikelboom McMaster University www. phri .ca
Uninterrupted dabigatran versus warfarin in patients undergoing catheter ablation of AF The RE-CIRCUIT Trial www. phri .ca October 4, 2017
Design Screening Uninterrupted 0-2 weeks dabigatran 150 mg bid • Primary endpoint: incidence of adjudicated Paroxysmal or ISTH MBEs from venous persistent Primary endpoint access up to 8 weeks post- non-valvular AF ablation † patients scheduled Follow-up 1 week for catheter ablation* R • Secondary endpoints included adjudicated Uninterrupted warfarin (INR thromboembolic events from 2.0-3.0) venous access to 8 weeks post-ablation † 8 weeks 4-8 weeks Ablation www. phri .ca Calkins H, et al. N Engl J Med . 2017;376:1627 – 1636 October 4, 2017
Primary outcome: major bleeding 8 Absolute risk n = 22 difference -5.3% (95% CI -8.4, -2.2) Patients with ISTH major bleeding events, % 6.9% P = 0.0009 6 Relative risk reduction 77.2% 4 n = 5 2 1.6% 0 Dabigatran Warfarin n = 317 n = 318 www. phri .ca Calkins H, et al. N Engl J Med . 2017;376:1627 – 1636 October 4, 2017
2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on ablation of AF Level of Setting Recommendation Class evidence Pre-ablation Uninterrupted warfarin or dabigatran I A Uninterrupted rivaroxaban I B Uninterrupted NOAC IIa B other than dabigatran or rivaroxaban During ablation Heparin should be administered I B Continue anticoagulation for at least 2 months Post-ablation I C after ablation www. phri .ca Calkins H, et al. Europace 2017 Sep 15. doi: 10.1093/europace/eux275. [Epub ahead of print] October 4, 2017
Dual antithrombotic therapy with dabigatran after PCI in patients with AF The RE-DUAL Trial www. phri .ca October 4, 2017
Design Dabigatran 150 mg BID + P2Y12 inhibitor Mean duration of follow-up: Patients ~14 months with AF Dabigatran 110 mg BID + P2Y12 inhibitor R undergoing PCI with stenting Warfarin (INR 2.0 – 3.0) + P2Y12 inhibitor + ASA Randomization ≤120 hours 6-month minimum treatment duration with visits every 3 months for the first year, then visits N=2725 post-PCI* and telephone contact alternating every 3 months and a 1-month post-treatment visit Dabigatran (110 or 150 mg) P2Y12 inhibitor Warfarin P2Y12 inhibitor 1 month of ASA (BMS) 3 months of ASA (DES) www. phri .ca Cannon CP, et al. N Engl J Med 2017 October 4, 2017
Primary outcome: major or CR non-major bleeding 40 40 HR: 0.52 (95% CI: 0.42 – 0.63) HR: 0.72 (95% CI: 0.58 – 0.88) Warfarin Warfarin 35 35 Non-inferiority P<0.0001 Non-inferiority P<0.0001 triple therapy triple therapy P<0.0001 P=0.002 30 30 Probability of event (%) 25 25 Dabigatran 150 mg 20 20 dual therapy Dabigatran 110 mg 15 15 dual therapy 10 10 5 5 0 0 0 90 180 270 450 0 90 180 270 450 360 540 630 720 360 540 630 720 Time to first event (days) Time to first event (days) www. phri .ca Cannon CP, et al. N Engl J Med 2017 October 4, 2017
Intracranial bleeding 1,5 Patients with outcome event (%) HR: 0.30 (95% CI: 0.08 – 1.07) HR: 0.12 (95% CI: 0.02 – 0.98) P=0.064 P=0.047 1 1.0% 1.0% 0,5 ARR: 0.7% ARR: 0.9% 0.3% 0.1% 0 Dabigatran 110 mg Warfarin triple therapy Dabigatran 150 mg Warfarin triple therapy dual therapy (n=981) dual therapy (n=764) (n=981) (n=763) www. phri .ca Cannon CP, et al. N Engl J Med 2017 October 4, 2017
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