Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation

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1 Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation Drew Baldwin, MD Virginia Mason Seattle, Washington NCVH May 29, :15 pm

2 I have no disclosures.

3 Stroke risk reduction in non-valvular atrial fibrillation Prevention of DVT after hip or knee surgery Risk reduction for recurrent DVT Treatment of DVT and PE aspirin warfarin (Coumadin) dabigatran (Pradaxa) rivaroxaban (Xarelto) apixaban (Eliquis) FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved FDA approved edoxaban (Savaysa) FDA approved FDA approved betrixaban Not yet FDA approved Not yet FDA approved Not yet FDA approved Not yet FDA approved

4 ACC/AHA/HRS Class I recommendations regarding patient with AF Calculate the CHADS-VASc score Recommend an oral anticoagulant for patients with NVAF and prior stroke, prior TIA, or a CHADS-VASc score 2 Use shared decision making with the patient to decide on a plan for stroke risk reduction, considering the risks for stroke and bleeding Re-evaluate stroke and bleeding risks periodically

5 CHADS 2 -VASc acronym Score CHADS 2 -VASc score Annual stroke risk CHF 1 Hypertension 1 Age 75 1 Diabetes mellitus 1 0 0% 1 1.3% 2 2.2% 3 3.2% Stroke (prior stroke / TIA / thromboembolism) % 5 6.7% Vascular (prior MI / PAD / aortic plaque) Age 65 1 Sex characteristic (female) % 7 9.6% 8 6.7% %

6 Friberg L, et al. Circulation 2012; 125:

7 Non-valvular atrial fibrillation CHADS-VASc score = 0 CHADS-VASc score = 1 CHADS-VASc score 2 No therapy No therapy or oral anticoagulant or aspirin or aspirin + clopidogrel Oral anticoagulant

8 Oral anticoagulant Mechanism of action warfarin (Coumadin) Depletes vitamin K1 Inhibits synthesis of clotting factors II, VII, IX, X, protein C, protein S, and protein Z dabigatran (Pradaxa) Directly inhibits factor II (thrombin) rivaroxaban (Xarelto) Directly inhibits factor Xa apixaban (Eliquis) Directly inhibits factor Xa edoxaban (Savaysa) Directly inhibits factor Xa

9 Oral anticoagulant Dosing for normal kidney function Dosing for reduced kidney function Dosing for kidney failure warfarin (Coumadin) Dose adjusted for INR 2-3 Dose adjusted for INR 2-3 Dose adjusted for INR 2-3 dabigatran (Pradaxa) 150 mg twice daily 75 mg twice daily for CrCl ml/min Not recommended rivaroxaban (Xarelto) 20 mg daily with the evening meal 15 mg daily with the evening meal for CrCl ml/min Not recommended apixaban (Eliquis) 5 mg twice daily 2.5 mg twice daily if 2 of the following: age 80, weight 60 kg, Cr 1.5 mg/dl Not recommended edoxaban (Savaysa) 60 mg daily for CrCl ml/min (Not indicated for CrCl > 95 ml/min) 30 mg daily for CrCl ml/min or weight 60 kg Not recommended

10

11 Inclusion criteria for clinical trials RE-LY (dabigatran vs. warfarin) NVAF and one of the following: Prior stroke, TIA, or embolism LVEF < 40% HF with NYHA class 2 Age 75 years Age 65 years and one of the following: DM, CAD, or HTN ROCKET-AF (rivaroxaban vs. warfarin) NVAF and one of the following: Prior stroke, TIA, or embolism Two or more risk factors: HF or LVEF 35% HTN Age 75 DM ARISTOTLE (apixaban vs. warfarin) NVAF and one of the following: Prior stroke, TIA, or embolism LVEF 40% HF with NYHA class 2 Age 75 years Hypertension Diabetes mellitus ENGAGE-AF (edoxaban vs. warfarin) NVAF and one of the following: Prior stroke, TIA, or embolism Two or more risk factors: HF HTN Age 75 DM

12 RE-LY trial Dabigatran 150 mg twice daily Warfarin P value Stroke or systemic embolism 1.11% / year 1.69% / year P < All cause mortality 3.64% / year 4.13% / year P = Myocardial infarction 0.74% / year 0.53% / year P = Any bleeding 16.42% /year 18.15% /year P < Major bleeding 3.11% / year 3.36% / year P = 0.31 Major GI bleeding 1.51% / year 1.02% / year P < Intracranial hemorrhage 0.10% / year 0.38% / year P < Premature drug discontinuation 15.5% 10.2% Net clinical outcome (vascular events, bleeding, and death) 6.91% / year 7.64% / year P = 0.04 Connolly SJ, et al. N Engl J Med 2009; 361:

13 Rocket-AF trial Rivaroxaban mg daily Warfarin P value Stroke or systemic embolism 1.7% / year 2.2% / year P < All cause mortality 1.9% / year 2.2% / year P = 0.07 Myocardial infarction 0.9% / year 1.1% / year P = 0.12 Any bleeding 14.9% /year 14.5% / year P = 0.44 Major bleeding 3.6% / year 3.4% / year P = 0.58 Major GI bleeding 3.2% / year 2.2% / year P < Intracranial hemorrhage 0.5% / year 0.7% / year P = 0.02 Premature drug discontinuation 23.7% 22.2% Patel MR, et al. N Engl J Med 2011; 365:

14 ARISTOTLE trial Apixaban mg twice daily Warfarin P value Stroke or systemic embolism 1.27% / year 1.60% / year P < All cause mortality 3.52% / year 3.94% / year P = Myocardial infarction 0.53% / year 0.61% / year P = 0.37 Any bleeding 18.1% /year 25.8% / year P < Major bleeding 2.13% / year 3.09% / year P < Major GI bleeding 0.76% / year 0.86% / year P = 0.37 Intracranial hemorrhage 0.33% / year 0.80% / year P < Premature drug discontinuation 25.3% 27.5% P = Net clinical outcome (stroke, embolism, bleeding, and death) 6.13% / year 7.20% / year P < Granger CB, et al. N Engl J Med 2011;365:

15 ENGAGE-AF trial: edoxaban 60 mg dose Edoxaban 60 mg daily Warfarin P value Stroke or systemic embolism 1.18% / year 1.50% / year P = 0.02 All cause mortality 3.99% / year 4.35% / year P = 0.08 Myocardial infarction 0.70% / year 0.75% / year P = 0.60 Any bleeding 14.15% /year 16.40% / year P < Major bleeding 2.75% / year 3.43% / year P < Major GI bleeding 1.51% / year 1.23% / year P = 0.03 Intracranial hemorrhage 0.39% / year 0.85% / year P < Premature drug discontinuation 34.4% 34.5% Net clinical outcome (stroke, embolism, major bleeding, and death) 7.26% / year 8.11% / year P = Giugliano RP, et al. N Engl J Med 2013; 369:

16 ENGAGE-AF trial: edoxaban 30 mg dose Edoxaban 30 mg daily Warfarin P value Stroke or systemic embolism 1.61% / year 1.50% / year P = 0.44 All cause mortality 3.80% / year 4.35% / year P = Myocardial infarction 0.89% / year 0.75% / year P = 0.13 Any bleeding 10.68% /year 16.40% / year P < Major bleeding 1.61% / year 3.43% / year P < Major GI bleeding 0.82% / year 1.23% / year P < Intracranial hemorrhage 0.26% / year 0.85% / year P < Premature drug discontinuation 33.0% 34.4% Net clinical outcome (stroke, embolism, major bleeding, and death) 6.79% / year 8.11% / year P < Giugliano RP, et al. N Engl J Med 2013; 369:

17 Which NOACs showed significant benefit compared to warfarin? Dabigatran 150 mg Rivaroxaban Apixaban Edoxaban 60 mg Stroke Edoxaban 30 mg All cause mortality Myocardial infarction * Any bleeding Major bleeding Major GI bleeding * * * Intracranial hemorrhage Drug discontinuation * Net clinical outcome NOAC superior to warfarin * Warfarin superior to NOAC Not reported

18 Meta-analysis of novel anticoagulants vs. warfarin NOACs warfarin Stroke 2.40% 3.13% RR 0.77 ( ) Myocardial infarction 1.29% 1.29% RR 0.99 ( ) Mortality 5.61% 6.02% RR 0.89 ( ) Major bleeding 4.90% 5.54% RR 0.86 ( ) Intracranial hemorrhage 0.59% 1.30% RR 0.46 ( ) Dentali F, et al. Circulation 2012; 126:

19 Oral anticoagulant Reversal agents warfarin (Coumadin) vitamin K, prothrombin complex concentrate dabigatran (Pradaxa) hemodialysis, activated PCC, rfviia rivaroxaban (Xarelto) Andexanet alfa, PCC, rfviia apixaban (Eliquis) Andexanet alfa, PCC, rfviia edoxaban (Savaysa) Andexanet alfa (not yet approved), PCC, rfviia

20 Major interactions Verapamil Increases concentration by % Dronedarone Increases concentration by % Azoles (ketoconazole, itra, etc...) Increases concentration up to 160% Protease inhibitors (ritonavir) Increases concentration up to 150% CYP 3A4 inhibitors (phenytoin, phenobarbital, carbamazepine, rifampin, St. John s wort) Decreases concentration by 35-65% Minor interactions Diltiazem Increases concentration of rivaroxaban by 40% Amiodarone Increases concentration of dabigatran by 50% Clarithromycin, erythromycin Increase concentrations by 15-50% Proton pump inhibitors Decrease concentration of dabigatran by 10-30%

21 Warfarin Dabigatran Rivaroxaban Apixaban Edoxaban Monthly drug cost Annual drug cost Warfarin dose monitoring (20 visits x charge) $10.88 $ $ $ $ $ $ $ $ $ $ Additional indirect costs (missed work, travel) $30 x 20 visits $ Total annual cost $ $ $ $ $

22 What do I do in my practice? Decide who to treat Calculate the CHADS-VASc score Assess the bleeding risk Educate, counsel, and discuss preferences with the patient For CHADS-VASc score 2: Start a factor Xa inhibitor > dabigatran > warfarin >> clopidogrel + aspirin Monitor therapy at least annually Assess compliance Review thromboembolic events, bleeding events, and side effects Review changes in other medications and OTC supplements Measure creatinine, LFTs, hemoglobin Measure creatinine every 3-6 months for patients with CrCl < 60 ml/min, age > 75, or other significant medical conditions

23 Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation Drew Baldwin, MD Virginia Mason Seattle, Washington NCVH May 29, :15 pm

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