NEW APPROACHES AND NEW ANTICOAGULANTS FOR … · OUT-OF-POCKET COSTS TO MEDICARE PT Armstrong et al...
Transcript of NEW APPROACHES AND NEW ANTICOAGULANTS FOR … · OUT-OF-POCKET COSTS TO MEDICARE PT Armstrong et al...
4/29/2015
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Melissa R. Robinson, MD FACC FHRS CCDSAssistant Professor of Medicine
Director of the Complex Arrhythmia Service
NEW APPROACHES AND NEW ANTICOAGULANTS
FOR ATRIAL FIBRILLATION
MAY 1, 2015
• 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
POINTS TO MAKE
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• Atrial Fibrillation Ablation• Review of Anticoagulants• Agent Selection• Dosing• Percutaneous Left Atrial Appendage
Closure
OUTLINE
PREVALENCE OF AFIB
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AF NOMENCLATURE
2014 AHA/ACC/HRS AF GUIDELINES FOR RHYTHM CONTROL
January C, JACC 2014;64(21):e1
Catheter ablation can be first line therapy in Paroxysmal AF
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• Treatment of comorbidities
•Valve disease
•OSA
•HTN
• Lifestyle changes
•Weight loss
•Exercise
• Patient selection• Technology
IMPROVING OUTCOMES FOR AF ABLATION
Akoum N JCE 2011;22(1):16
ENERGY SOURCES FOR AF ABLATION
Andrade J, Circ Arrhy Electro 2013;6:218
Cryoablation Lesion Radiofrequency Lesion
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CRYOBALLOON ABLATION
• 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
AF AND STROKE
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CRYPTOGENIC STROKE AND AF – CRYSTAL AF
Sanna T et al NEJM 2014; 370:2478
INCIDENCE OF AF IN CIED POPULATION
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CHA2DS2-VASC SCORE: NEGATIVE PREDICTIVE VALUE
Olsen, JB et al Thrombo and Hemost 2012; 107: 1172-9
DANISH NATIONAL PATIENT REGISTRIES 1997-2008:CHADS2 = 0 OR 1 (N=47,576); NONVALVULAR AF; NO OAC
CALCULATORS
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OAC DECISION TREE IN AF
COAGULATION CASCADE AND OACS
Apixaban, Rivaroxabanand Edoxaban
Dabigitran
Warfarin
January C, JACC 2014;64(21):e1
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WARFARIN V. PLACEBO
64% RRR
NNT : 37 (primary prevention) and 12 (secondary prevention)
Hart et al Ann Intern Med 2007; 146:857-67
n = 2,900; nonvalvular AF
SWEDISH AF COHORT STUDY Swedish National Hospital Discharge Registry 2005-2008:
Study population:n=182,678
nonvalvular AFmean age 76
53% M
Follow-up: 1.5 years Ann
ual e
vent
rat
es
CHA2DS2-VASc score
Friberg et al Circulation 2012; 125: 2298-2307
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NET CLINICAL BENEFIT OF OAC IN AF:ISCHEMIC CVA MINUS HEMORRHAGIC CVA
Friberg et al Circulation 2012; 125: 2298-2307
OAC DECISION TREE IN AF
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ENGAGE AF-TIMI 48
STROKE OR SYSTEMIC EMBOLISM
Ruff, C et al Lancet 2014; 383(9921):955-62
19% reduction in stroke, p = <0.0001
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MAJOR BLEEDING IN THE DOAC TRIALS
Ruff, C et al Lancet 2014; 383(9921):955-62
14% reduction in major bleeding, p = 0.06
EFFICACY AND SAFETY
Ruff, C et al Lancet 2014; 383(9921):955-62
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Renal Function
(mL/min C-G)
Dabigatran(Pradaxa)
Rivaroxaban(Xarelto)
Apixaban(Eliquis)
Edoxaban
CrCl > 50
150mg bid§
20mg qd 5mg bid*
2.5mg bid if any 2 of:
≥ 80 y.o.≤ 60 kgCr ≥ 1.5
60mg qd
CrCl 30-50
15mg qd* 30mg qd
CrCl 15-30 75mg bid§
ESRD or HD Not recommended
If HD, 5mg bid or 2.5mg bid if
>80y.o. or <60kg
Notrecommended
DOSING IN RENAL FAILURE
• Using MDRD may lead to under-dosing of DOACs relative to trial data
CRCL V. GFR (MDRD)
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DOAC: DRUG INTERACTIONSDrug dabigatran rivaroxaban apixaban edoxaban
Verapamil +12-180%, dose minor effect ? +50%, dose
Diltiazem none minor effect +40% ?
Amiodarone +12-60% minor effect ? no effect
P-glycoprotein / CYP3A4 inhibitors
Dronedarone +70-100%, CI ? ? +85%, dose
Ketoconazole +150%, CI +160%, CI +100%, CI ?
Protease inhib ? + 150%, CI ? ?
rifampicin - 66%, CI - 50% -54%, CI -35%
P-glycoprotein / CYP3A4 inducers
St Johns wortcarbemazepinephenytoinphenobarbital
Heidbuchel, H et al Europace 2013; 15:625-51
SPECIFIC SCENARIOS
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• 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
DISCONTINUATION FOR SURGERY
BLEEDING ON DOAC
Levy et al JACC:CI 2014; 7(12):1333
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• Normal aPTT excludes bleeding from dabigitran
• Prothrombin time usually elevated with apixaban/rivaroxaban/edoxaban
BLEEDING ON DOACS
Levy et al JACC:CI 2014; 7(12):1333
Rivaroxaban Dabigitran ApixabanWarfarin (generic)
Regents $315Preferredstatus
$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
REIMBURSEMENT CONSIDERATIONS
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Image courtesy of M. Reisman, MD
NONPHARMACOLOGIC STROKE REDUCTION IN AF
LEFT ATRIAL APPENDAGE CLOSURE DEVICES
AmplatzerPLAATO
Watchman LariatBajaj N, JACC:Card Interv 2014;7(3):296
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LEFT ATRIAL APPENDAGE VARIABILITY
• 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%
LEFT ATRIAL APPENDAGE CLOSURE
Bajaj N, JACC:Card Interv 2014;7(3):296
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COMPARISION OF STROKE PREVENTION
Bajaj N, JACC:Card Interv 2014;7(3):296
OUT-OF-POCKET COSTS TO MEDICARE PT
Armstrong et al JACC 2014;63(12_S)
• Includes Medicare deductibles and co-insurance for:
•LAAC cost
•Labwork
•Clinic visits
•Acute clinical events
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• 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
TAKE HOME POINTS
QUESTIONS?