NEW APPROACHES AND NEW ANTICOAGULANTS FOR ATRIAL FIBRILLATION
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1 NEW APPROACHES AND NEW ANTICOAGULANTS FOR ATRIAL FIBRILLATION MAY 1, 2015 Melissa R. Robinson, MD FACC FHRS CCDS Assistant Professor of Medicine Director of the Complex Arrhythmia Service POINTS TO MAKE Scope of the problem Monitoring for silent AF Lifestyle Influence (use P s slides) OSA Ablation cryo, rotors Combination with LAA closure -- Watchman NOACs Meet the players How to chose Special considerations Cases at the end 1
2 OUTLINE Atrial Fibrillation Ablation Review of Anticoagulants Agent Selection Dosing Percutaneous Left Atrial Appendage Closure PREVALENCE OF AFIB 2
3 AF NOMENCLATURE 2014 AHA/ACC/HRS AF GUIDELINES FOR RHYTHM CONTROL Catheter ablation can be first line therapy in Paroxysmal AF January C, JACC 2014;64(21):e1 3
4 IMPROVING OUTCOMES FOR AF ABLATION Treatment of comorbidities Valve disease OSA HTN Lifestyle changes Weight loss Exercise Patient selection Technology Akoum N JCE 2011;22(1):16 ENERGY SOURCES FOR AF ABLATION Cryoablation Lesion Radiofrequency Lesion Andrade J, Circ Arrhy Electro 2013;6:218 4
5 CRYOBALLOON ABLATION AF AND STROKE AF increases stroke risk at least 5-fold AF accounts for 15-20% of all strokes AF associated strokes have higher mortality and morbidity AF ultimately found in 20% of cryptogenic strokes 5
6 CRYPTOGENIC STROKE AND AF CRYSTAL AF Sanna T et al NEJM 2014; 370:2478 INCIDENCE OF AF IN CIED POPULATION 6
7 HOW MUCH AF IS TOO MUCH? OAC IN ACUTE CVA PTS WITH KNOWN AF 7
8 CHADS 2 CHA 2 DS 2 VASC CHADS 2 CHA 2 DS 2 VASC ASA ASA or OAC OAC ASA ASA or OAC OAC 8
9 CHA 2 DS 2 -VAS C SCORE: NEGATIVE PREDICTIVE VALUE DANISH NATIONAL PATIENT REGISTRIES : CHADS 2 = 0 OR 1 (N=47,576); NONVALVULAR AF; NO OAC Olsen, JB et al Thrombo and Hemost 2012; 107: CALCULATORS 9
10 OAC DECISION TREE IN AF COAGULATION CASCADE AND OACS Warfarin Apixaban, Rivaroxaban and Edoxaban Dabigitran January C, JACC 2014;64(21):e1 10
11 WARFARIN V. PLACEBO n = 2,900; nonvalvular AF 64% RRR NNT : 37 (primary prevention) and 12 (secondary prevention) Hart et al Ann Intern Med 2007; 146: SWEDISH AF COHORT STUDY Swedish National Hospital Discharge Registry : Study population: n=182,678 nonvalvular AF mean age 76 53% M Follow-up: 1.5 years Annual event rates CHA 2 DS 2 -VASc score Friberg et al Circulation 2012; 125:
12 NET CLINICAL BENEFIT OF OAC IN AF: ISCHEMIC CVA MINUS HEMORRHAGIC CVA Friberg et al Circulation 2012; 125: OAC DECISION TREE IN AF 12
13 ENGAGE AF-TIMI 48 STROKE OR SYSTEMIC EMBOLISM 19% reduction in stroke, p = < Ruff, C et al Lancet 2014; 383(9921):
14 MAJOR BLEEDING IN THE DOAC TRIALS 14% reduction in major bleeding, p = 0.06 Ruff, C et al Lancet 2014; 383(9921): EFFICACY AND SAFETY Ruff, C et al Lancet 2014; 383(9921):
15 DOSING IN RENAL FAILURE Renal Function (ml/min C-G) Dabigatran (Pradaxa) Rivaroxaban (Xarelto) Apixaban (Eliquis) Edoxaban CrCl > 50 20mg qd 5mg bid* 60mg qd CrCl CrCl mg bid 75mg bid 15mg qd* 2.5mg bid if any 2 of: 80 y.o. 60 kg Cr mg qd ESRD or HD Not recommended If HD, 5mg bid or 2.5mg bid if >80y.o. or <60kg Not recommended CRCL V. GFR (MDRD) Using MDRD may lead to under-dosing of DOACs relative to trial data 15
16 DOAC: DRUG INTERACTIONS Drug dabigatran rivaroxaban apixaban edoxaban Verapamil %, dose minor effect? +50%, dose Dronedarone %, CI?? +85%, dose Amiodarone % minor effect? no effect Diltiazem none minor effect +40%? Ketoconazole +150%, CI +160%, CI +100%, CI? Protease inhib? + 150%, CI?? P-glycoprotein / CYP3A4 inhibitors rifampicin - 66%, CI - 50% -54%, CI -35% St Johns wort carbemazepine phenytoin phenobarbital P-glycoprotein / CYP3A4 inducers Heidbuchel, H et al Europace 2013; 15: SPECIFIC SCENARIOS 16
17 DISCONTINUATION FOR SURGERY Low risk surgery 1 day Higher risk surgery 2 days these agents for 1 day (2 doses for dabigatran and apixaban; 1 dose for rivaroxaban) before the procedure is generally sufficient for patients with normal renal function BLEEDING ON DOAC Levy et al JACC:CI 2014; 7(12):
18 BLEEDING ON DOACS Normal aptt excludes bleeding from dabigitran Prothrombin time usually elevated with apixaban/rivaroxaban/edoxaban Levy et al JACC:CI 2014; 7(12):1333 REIMBURSEMENT CONSIDERATIONS Regents $315 Preferred status Rivaroxaban Dabigitran Apixaban Warfarin (generic) $318 $317 $6.60/mo Medicaid Preferred Preferred Non-preferred Non-preferred Premera Tier 2 Tier 2 Tier 2 Non-preferred Group Health NF NF NF Formulary Molina Tier 2 Tier 2 Tier 2 Preferred 18
19 NONPHARMACOLOGIC STROKE REDUCTION IN AF Image courtesy of M. Reisman, MD LEFT ATRIAL APPENDAGE CLOSURE DEVICES Amplatzer PLAATO Watchman Lariat Bajaj N, JACC:Card Interv 2014;7(3):296 19
20 LEFT ATRIAL APPENDAGE VARIABILITY LEFT ATRIAL APPENDAGE CLOSURE Overall stroke risk 0.7/100 patient years Procedural failure rate of 7-9% Access site complication rate 8.6% Pericardial effusion rate 4.1% Bajaj N, JACC:Card Interv 2014;7(3):296 20
21 COMPARISION OF STROKE PREVENTION Bajaj N, JACC:Card Interv 2014;7(3):296 OUT-OF-POCKET COSTS TO MEDICARE PT Includes Medicare deductibles and co-insurance for: LAAC cost Labwork Clinic visits Acute clinical events Armstrong et al JACC 2014;63(12_S) 21
22 TAKE HOME POINTS AF Catheter ablation techniques continue to improve and outcomes in selected patients are favorable Direct oral anticoagulants offer many benefits over warfarin in selected patients Left atrial appendage closure is emerging as a new tool for stroke reduction in AF QUESTIONS? 22
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