Anticoagulation Therapy Your key questions for 2018 clinical - - PowerPoint PPT Presentation

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Latest Frontiers in Anticoagulation Therapy

Your key questions for 2018 clinical practice addressed

Course Director

• Prof. Saskia Middeldorp

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Anticoagulation 2017: the key lessons and implications from recent trials

John Eikelboom McMaster University

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Uninterrupted dabigatran versus warfarin in patients undergoing catheter ablation of AF

The RE-CIRCUIT Trial

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Design

• Primary endpoint:

incidence of adjudicated ISTH MBEs from venous access up to 8 weeks post- ablation†

• Secondary endpoints

included adjudicated thromboembolic events from venous access to 8 weeks post-ablation† Primary endpoint Paroxysmal or persistent non-valvular AF patients scheduled for catheter ablation* Screening 0-2 weeks Uninterrupted dabigatran 150 mg bid Ablation Follow-up 1 week R 4-8 weeks 8 weeks Uninterrupted warfarin (INR 2.0-3.0) Calkins H, et al. N Engl J Med. 2017;376:1627–1636

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Primary outcome: major bleeding

Dabigatran n = 317 Warfarin n = 318 Absolute risk difference -5.3% (95% CI -8.4, -2.2) P = 0.0009 Relative risk reduction 77.2% 2 4 6 8 Patients with ISTH major bleeding events, %

1.6% 6.9%

n = 5 n = 22

Calkins H, et al. N Engl J Med. 2017;376:1627–1636

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2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on ablation of AF

Calkins H, et al. Europace 2017 Sep 15. doi: 10.1093/europace/eux275. [Epub ahead of print]

Setting Recommendation Class Level of evidence Pre-ablation Uninterrupted warfarin or dabigatran I A Uninterrupted rivaroxaban I B Uninterrupted NOAC

• ther than dabigatran or rivaroxaban

IIa B During ablation Heparin should be administered I B Post-ablation Continue anticoagulation for at least 2 months after ablation I C

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Dual antithrombotic therapy with dabigatran after PCI in patients with AF

The RE-DUAL Trial

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Design

R

Randomization ≤120 hours post-PCI* 6-month minimum treatment duration with visits every 3 months for the first year, then visits and telephone contact alternating every 3 months and a 1-month post-treatment visit

Patients with AF undergoing PCI with stenting Dabigatran 150 mg BID + P2Y12 inhibitor Dabigatran 110 mg BID + P2Y12 inhibitor Warfarin (INR 2.0–3.0) + P2Y12 inhibitor + ASA

Dabigatran (110 or 150 mg) Warfarin 1 month of ASA (BMS) 3 months of ASA (DES)

N=2725

Mean duration of follow-up: ~14 months

P2Y12 inhibitor P2Y12 inhibitor

Cannon CP, et al. N Engl J Med 2017

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Primary outcome: major or CR non-major bleeding

Probability of event (%)

90 180 270 360 450 540 630 720 Time to first event (days) 40 35 30 25 20 15 10 5

Warfarin triple therapy Dabigatran 110 mg dual therapy

HR: 0.52 (95% CI: 0.42–0.63) Non-inferiority P<0.0001 P<0.0001

90 180 270 360 450 540 630 720 Time to first event (days) 40 35 30 25 20 15 10 5

Dabigatran 150 mg dual therapy Warfarin triple therapy

HR: 0.72 (95% CI: 0.58–0.88) Non-inferiority P<0.0001 P=0.002

Cannon CP, et al. N Engl J Med 2017

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Intracranial bleeding

0,5 1 1,5 Dabigatran 110 mg dual therapy (n=981) Warfarin triple therapy (n=981)

HR: 0.30 (95% CI: 0.08–1.07) P=0.064

Dabigatran 150 mg dual therapy (n=763) Warfarin triple therapy (n=764)

HR: 0.12 (95% CI: 0.02–0.98) P=0.047 0.3% 1.0% 0.1% 1.0%

Patients with outcome event (%) ARR: 0.9% ARR: 0.7% Cannon CP, et al. N Engl J Med 2017