Anticoagulation Therapy Update

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1 Anticoagulation Therapy Update JUDY R. WALLING, FNP-BC ARRHYTHMIA MANAGEMENT MUSC CARDIOLOGY Outline Who do we anticoagulate? Review classes of Anticoagulants Review examples of Anticoagulants Review CHADS2 and CHADS2VASc Scoring New and old anticoagulants PEARLS of wisdom Case Studies Reasons to Anticoagulate Mechanical Valve DVT and DVT prophylaxis Atrial Fibrillation Low ejection fraction LV or LA thrombus PE Post MI Atrial Flutter Prior CVA/TIA Post Ablation Post Cardioversion 1

2 Classes of Anticoagulation Inhibitors of clotting factor synthesis Example - warfarin Inhibitors of thrombin Example - dabigatran Direct factor Xa inhibitors Example rivaroxaban and apixaban Antiplatelet medications Example aspirin, clopidogrel, prasugrel, and ticagrelor Types of Anticoagulation Warfarin (Coumadin ) Heparin Aspirin Clopidogrel (Plavix ) Prasugrel (Effient ) Ticagrelor (Brilinta ) Dipyridamole (Persantine ) Enoxaparin (Lovenox ) Ardeparin (Normiflo ) Dalteparin (Fragmin ) Ticlopidine (Ticlid ) Danaparoid (Orgaran ) Tinzaparin (Innohep ) Dabigatran etexilate (Pradaxa ) Rivaroxaban (Xarelto ) Apixaban (Eliquis ) 2

3 CHADS2 Scoring Clinical prediction rule for estimating the risk of stroke in patients with afib. C Congestive heart failure = 1pt H Hypertension = 1pt A Age > 75 = 1pt D Diabetes = 1pt S Prior Stroke or TIA = 2pts CHADS2 score Stroke Risk % % % % % % % According to the findings of the validation study, the risk for stroke as a percentage per year is as above. Recommendations for anticoagulation: *0 score is a low risk and aspirin therapy is recommended daily. *1 score is a moderate risk and aspirin or warfarin is recommended. * 2 score is a moderate to high risk and warfarin is recommended. 3

4 CHADS2VASc Scoring - C Congestive heart failure = 1pt - H Hypertension = 1pt - A Age > 75 = 2pt - D Diabetes = 1pt - S Prior Stroke or TIA = 2pts - V Vascular Disease (prior MI. PAD, or aortic plaque) = 1pt - A Age = 1pt - Sc Sex Category (female) = 1pt **adjusted stroke risk according to CHADS2 VASc Score ranges from 1.3% for a score of 1 to 15.2% for a score of 9.** Coumadin 4

5 Out with the old and in with the NEW!!!! Pradaxa RE-LY Trial multicentered,multinational, randomized, parallel-group trial. 18,113 patients enrolled with nonvalvular AF with at least one risk factor for stoke such as previous stroke, TIA, systemic embolism, LVEF<40%, symptomatic heart failure, age > or = 75 years of age or age > or =65 years of age and one of the following: DM, HTN, or verified CAD Mean age of patients was 71.5yo Mean CHADS2 score was 2.1 Objective was to demonstrate non-inferiority of Pradaxa to Coumadin in stroke or systemic embolism prevention. Conclusion: 1) Additional 35% risk reduction of stroke/systemic embolism verses Coumadin. 2) Superior reduction of ischemic and hemorrhagic stroke verses Coumadin. 3) Similar rate of major bleeds with Pradaxa verses Coumadin. 5

6 Plain and Simple: When compared with Coumadin, Pradaxa at 150mg BID dosing is more effective at preventing stroke and systemic embolism with a similar risk of major bleeding. Dosing 150mg BID verses 75mg BID Side effects Considerations Switching from drug to drug Xarelto ROCKET-AF randomized, double-blind, doubledummy, event-driven trial. 14,264 patients were randomized to 1,100 sites across 45 countries. Patients had a history of stroke or at least 2 additional independent risk factors for future strokes. Mean age of patients was 73yo Mean CHADS2 score was 3.5 6

7 Objective was to determine whether Xarelto was noninferior to Coumadin for primary endpoint of stroke or systemic embolism. Conclusion: 1) Xarelto was noninferior to Coumadin for the prevention of stroke or systemic embolism. 2) There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the Xarelto group. Plain and Simple: Xarelto is as good as Coumadin at stroke prevention in nonvalvular atrial fibrillation and there is no significant increase in risk of bleeding. Dosing 20mg qd verses 15mg qd Side effects Considerations Switching from drug to drug 7

8 Eliquis ARISTOTLE large Phase III, randomized, double-blind, double-dummy, multicentered trial. 18,201 patients were randomized Patients had a history of nonvalvular afib and 1 or more additional risk factors for stroke including prior stroke or TIA, prior systemic embolism, age greater than or equal to 75yo, diabetes, hypertension, heart failure, or EF less than 40%. Mean age of patients was 69yo Mean CHADS2 score was 2.1 Objective was to determine whether Eliquis was noninferior to Coumadin in reducing the risk of stroke (systemic or hemorrhagic) and systemic embolism. Conclusion: Eliquis demonstrated superior risk reductions verses Coumadin in 3 outcomes Stroke and systemic embolism Major bleeding All-cause mortality Plain and Simple: Eliquis is the only anticoagulant of the 3 that was superior in all 3 categories.stroke prevention, major bleeding, and all cause mortality. ONLY trial that showed a decrease in risk of major bleeding. ONLY trial that showed a decrease in mortality. 8

9 HOME RUN THEY SWUNG FOR THE FENCE AND THEY SCORED!!! Dosing 5mg BID verses 2.5mg BID Side effects Considerations Switching from drug to drug Sooooooo With all the newer anticoagulants, i.e. Pradaxa, Xarelto, and Eliquis there is no antidote!!! Dabigatran and dialysis Charcoal for acute OD PCC 4 factors 2, 7, 9, and 10 MUSC does have a protocol PCC on hand to use 9

10 With all the newer anticoagulants think about interactions. Some increase the amount of blood thinner in the system, i.e. bleeding risk. Antifungals Antiretrovirals Antibiotics (some, not all) Some decrease the amount of blood thinner in system, i.e. stroke risk. Antiseizures BLACK BOX WARNINGS Why should we switch our patients to a new anticoagulant - For every 40 patients we switch from Coumadin to a new anticoagulant, we will save 1 life. - For every 150 patients we switch from Coumadin to a new anticoagulant, we will prevent one hemorrhagic stroke. 10

11 Weaknesses of the Trials - All 3 of the trials only included 1-2% of African Americans How will they respond to therapy. - We should consider head to head studies for the new anticoagulants. - We are still learning about absorption as noted with Pradaxa in an earlier slide. DID YOU KNOW.. B E C A U S E I D I D N O T!!!!!!!!!!!!!!!!!!!? Taking an SSRI or SSNRI doubles or triples your risk of bleeding. Taking an SSRI or SSNRI with some form of antiplatelet such as aspirin, Motrin, Plavix, etc. increase your risk of bleeding 4-5X s. Taking an SSRI or SSNRI with an oral anticoagulant, SCAREY because we do not know how much it increases your risk of bleeding. 11

12 CASE STUDIES Case Study 1 Mr. Jones is a 52yo man with a history of diabetes and hypertension who comes to your primary care practice with complaints of a fluttering to his chest for three days. You order an EKG that reveals his is atrial fibrillation with a heart rate at 86bpm. He is asymptomatic otherwise. It will be weeks before he can see a cardiologist and he is stable otherwise. What would you do? 1) Aspirin 325mg once daily 2) Coumadin 2.5mg once daily 3) Pradaxa 75mg twice daily 4) Xarelto 20mg once daily 5) Nothing because he has a low CHADS2 and CHADS2VASc score 12

13 Case Study 2 Mrs. Green is a 66yo woman with a known history of atrial fibrillation and has been recently started on Pradaxa 150mg BID for anticoagulation by her local cardiologist. She comes to you today for her routine physical complaining of new onset of heartburn and indigestion for about one month s time. What would you do? 1) Protonix 40mg once daily 2) GI referral 3) Switch her to ASA 81mg once daily because she has a low CHADS2VASc score. 4) Decrease Pradaxa to 75mg BID 5) Switch patient to Xarelto 20mg once daily Case Study 3 Ms. Brown is a 75yo woman with a known history of atrial fibrillation, congestive heart failure, coronary artery disease, and remote history of GI bleed. She is interested in switching from Coumadin therapy to one of the newer anticoagulants that she has seen on TV. What would you recommend for her? 13

14 1) Switch her to Aspirin (2) 81mg once daily because she has a low CHADS2VASc Score 2) Switch her to Eliquis 5mg BID 3) Encourage her to continue Coumadin since she is not reporting any adverse effects from the medication 4) Pradaxa 150mg BID 5) Xarelto 20mg once daily FUTURE AVERROES TRIAL WHAT WILL THEY REPORT AT THE ACC AND WILL IT CHANGE HOW WE PRACTICE? CONTACT ME W A L L I N G M U S C. E D U 14

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