9/12/2019 Disclosures Should We Be Anticoagulating the • Consulting/Honoraria CHA2DS2-VASc=1 • Medtronic, Abbott, Boston Scientific, Biotronik, Biosense-Webster, Bristol-Myers Squibb, Patient? Janssen Pharmaceutical, Pfizer • Research Grants • Biosense-Webster, Biotronik • Equity Jonathan C. Hsu, MD, MAS Associate Professor • Acutus Medical Division of Cardiology, Section of Cardiac Electrophysiology September 13, 2019 Outline- Learning Objectives • Highlight data regarding the decision to prescribe oral anticoagulation “CHA2DS2-VASc score (OAC) in atrial fibrillation (AF) patients with a CHA2DS2-VASc =1 score recommended to assess • Recognize factors that may influence stroke risk” the decision to prescribe OAC, and understand why antiplatelet therapy (i.e. aspirin) may not be the answer January CT, et al. JACC 2014. 1
9/12/2019 CHA2DS2-VASc Instead of CHA2DS2-VASc Instead of CHADS2 Score CHADS2 Score Change in OAC eligible patients by Change in OAC eligible patients by current guideline recommendations current guideline recommendations Contemporary Trends in Oral Objectives Anticoagulant Prescription in Atrial Fibrillation Patients at Low to Moderate • Define the proportion of patients with AF qualifying for OAC by applying the Risk of Stroke After Guideline CHA 2 DS 2 -VASc score to patients with Recommended Change in Use of the a low CHADS 2 score CHADS2 to the CHA2DS2-VASc Score • New guideline recommendations to use for Thromboembolic Risk Assessment: CHA 2 DS 2 -VASc score An Analysis from the NCDR PINNACLE AF Registry David F. Katz, MD; Thomas Maddox, MD; Emily O’Brien, PhD; Anil Gehi, MD; Mintu Turakhia, MD; Steve Lubitz, MD; Paul Varosy, MD; Lucas Marzec, MD; Jonathan C. Hsu, MD, MAS Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017. Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017. 2
9/12/2019 Methods Adoption of the CHA 2 DS 2 -VASc score • AF patients enrolled in the ACC reclassifies 64.5% of AF patients with NCDR-PINNACLE Registry low CHADS 2 scores into a class I • 2008-2014 indication for OAC prescription. • CHADS 2 score of 0 or 1 • Calculated impact of adoption of the CHA 2 DS 2 -VASc score on proportion of patients indicated for OAC • Examined trends in prescription of OAC Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017. Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017. Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017. Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017. 3
9/12/2019 Lack of Appropriate OAC Appropriate Prescription of OAC Across the Spectrum of Stroke Risk in AF How are cardiovascular specialists in • >400,000 patients with AF the United States doing in the real • Large, real-world population world? • 2008-2012 • >100 practices, academic + private • Treated by cardiologist Hsu JC, et al. JAMA Cardiology 2016. Anticoagulation in CHA2DS2-VASc =1 Patients What do the Guidelines tell us? Oral Anticoagulant Use Does Not Top 50%, Even in the Highest Stroke Risk AF Patients Hsu, et al. JAMA Cardiology 2016. 4
9/12/2019 Therapy Summary- The New “With nonvalvular AF and a CHA2DS2-VASc score of 1, • CHA2DS2-VASc ≥2 no antithrombotic therapy or • Oral anticoagulation with warfarin or NOAC treatment with oral • CHA2DS2-VASc =1 anticoagulant or aspirin may • Oral anticoagulation with warfarin or NOAC or be considered” • ASA • Consider bleeding risk, compliance, patient preference • CHA2DS2-VASc =0 • No therapy or ASA January CT, et al. JACC 2014. January CT, et al. JACC 2014. 2019 AHA/ACC/HRS Update ESC Guidelines 2016 January CT, et al. JACC 2019. Kirchhof P, et al. Eur Heart J 2016. 5
9/12/2019 ESC Guidelines 2016 ESC Guidelines 2016 Kirchhof P, et al. Eur Heart J 2016. Kirchhof P, et al. Eur Heart J 2016. Expert Opinion Based on Data • Patient preference Anticoagulation in • Shared decision making CHA2DS2-VASc =1 Patients • Consider bleeding risk • HAS-BLED score So What Should We Do? • Consider risk factor contributing to CHA2DS2-VASc =1 • 65-74 (age) likely biggest risk factor • Female sex likely smallest risk factor • Consider NOAC vs. Warfarin • Aspirin? 6
9/12/2019 Female Sex- Is it really 1 point? • 2015 analysis- 140,420 AF patients Aspirin Prescription in (Swedish nationwide health registry) AF CHA 2 DS 2 -VASc score of 1 • Annual event rates varied between 0.5 and 0.9 Role in Stroke Risk Reduction percent for stroke • Annual ischemic stroke rate was 0.1 to 0.2 percent for women (their CHA 2 DS 2 -VASc score of 1 was derived from their sex) • Men, the annual ischemic stroke rate was 0.5 percent Friberg L, et al. JACC 2015. Background • Antithrombotic therapy with warfarin (and now NOACs) has been shown to: • Lower the risk of thromboembolism in patients with AF “With prior stroke, TIA, or • Effectiveness of Aspirin in reducing CHA2DS2-VASc score of stroke risk is debatable ≥2, OAC recommended including: warfarin, NOACs” January CT, et al. JACC 2014. 7
9/12/2019 “With nonvalvular AF and a “With nonvalvular AF and CHA2DS2-VASc score of 1, no antithrombotic therapy or CHA2DS2-VASc score of treatment with oral 0, it is reasonable to omit anticoagulant or aspirin may antithrombotic therapy” be considered” January CT, et al. JACC 2014. January CT, et al. JACC 2014. Antiplatelet versus Placebo • 8 trials, total of 4,876 patients • Aspirin 19% reduction (95% CI: -1% to 35%) in stroke incidence • ARR of 0.8% per year • Number needed to treat: 125 • 95% CI encompassed 0 • Includes the possibility that aspirin has no real effect on stroke reduction 8
9/12/2019 Aspirin versus Placebo • No study by itself shows benefit for Aspirin Use in Real- aspirin alone in preventing stroke in AF World Practice • Exception of the SPAF (Stroke Prevention in Atrial Fibrillation) trial Are we treating ourselves and not the patient? 38-40% of patients at moderate to high risk of stroke treated with Aspirin alone, not OAC! Hsu JC, et al. JACC 2016. Hsu JC, et al. Clin Pharmacol Ther. 2018. 9
9/12/2019 • Meta-analysis- 28 observational studies of NOACs vs. Coumadin • Large reduction of intracranial hemorrhage • Similar rates of ischemic stroke • Bleeding rates mirrored findings from RCTs Hsu JC, et al. Clin Pharmacol Ther. 2018. Ntaios G, et al. Stroke 2017. LAAO for CHA2DS2-VASc =1 • WATCHMAN FDA Approval 2015 • PROTECT and PREVAIL studies • Included patients with CHADS2=1 • Which means some patients with CHA2DS2-VASc =1 had LAAO • Procedural risks • In the United States- Payment • CMS coverage determination 10
9/12/2019 Summary THANK YOU • AF patients with a CHA2DS2-VASc =1 may benefit from treatment with OAC, however the decision to treat is complex Email: • OAC may be preferable over aspirin in Jonathan.Hsu@ucsd.edu certain patients, but patient preference is important Twitter: @JonHsuMD 11
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