Should We Be Anticoagulating the Consulting/Honoraria - - PDF document

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Should We Be Anticoagulating the Consulting/Honoraria - - PDF document

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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

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Should We Be Anticoagulating the CHA2DS2-VASc=1 Patient?

Jonathan C. Hsu, MD, MAS Associate Professor Division of Cardiology, Section of Cardiac Electrophysiology September 13, 2019

  • Consulting/Honoraria
  • Medtronic, Abbott, Boston Scientific, Biotronik,

Biosense-Webster, Bristol-Myers Squibb, Janssen Pharmaceutical, Pfizer

  • Research Grants
  • Biosense-Webster, Biotronik
  • Equity
  • Acutus Medical

Disclosures

  • Highlight data regarding the decision

to prescribe oral anticoagulation (OAC) in atrial fibrillation (AF) patients with a CHA2DS2-VASc =1 score

  • Recognize factors that may influence

the decision to prescribe OAC, and understand why antiplatelet therapy (i.e. aspirin) may not be the answer

Outline- Learning Objectives

“CHA2DS2-VASc score recommended to assess stroke risk”

January CT, et al. JACC 2014.

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CHA2DS2-VASc Instead of CHADS2 Score

Change in OAC eligible patients by current guideline recommendations

CHA2DS2-VASc Instead of CHADS2 Score

Change in OAC eligible patients by current guideline recommendations

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

Contemporary Trends in Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Low to Moderate Risk of Stroke After Guideline Recommended Change in Use of the CHADS2 to the CHA2DS2-VASc Score for Thromboembolic Risk Assessment:

An Analysis from the NCDR PINNACLE AF Registry

Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017.

  • Define the proportion of patients with

AF qualifying for OAC by applying the CHA2DS2-VASc score to patients with a low CHADS2 score

  • New guideline recommendations to use

CHA2DS2-VASc score

Objectives

Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017.

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  • AF patients enrolled in the ACC

NCDR-PINNACLE Registry

  • 2008-2014
  • CHADS2 score of 0 or 1
  • Calculated impact of adoption of the

CHA2DS2-VASc score on proportion of patients indicated for OAC

  • Examined trends in prescription of

OAC

Methods

Katz DF,…Hsu JC. Circ Cardiovasc Qual Outcomes 2017.

Adoption of the CHA2DS2-VASc score reclassifies 64.5% of AF patients with low CHADS2 scores into a class I indication for OAC prescription.

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.

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Appropriate Prescription of OAC Across the Spectrum

  • f Stroke Risk in AF

How are cardiovascular specialists in the United States doing in the real world?

Hsu JC, et al. JAMA Cardiology 2016.

  • >400,000 patients with AF
  • Large, real-world population
  • 2008-2012
  • >100 practices, academic + private
  • Treated by cardiologist

Lack of Appropriate OAC

Hsu, et al. JAMA Cardiology 2016.

Oral Anticoagulant Use Does Not Top 50%, Even in the Highest Stroke Risk AF Patients

Anticoagulation in CHA2DS2-VASc =1 Patients

What do the Guidelines tell us?

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  • CHA2DS2-VASc ≥2
  • Oral anticoagulation with warfarin or NOAC
  • CHA2DS2-VASc =1
  • Oral anticoagulation with warfarin or NOAC or
  • ASA
  • Consider bleeding risk, compliance, patient

preference

  • CHA2DS2-VASc =0
  • No therapy or ASA

Therapy Summary- The New

January CT, et al. JACC 2014.

“With nonvalvular AF and a CHA2DS2-VASc score of 1, no antithrombotic therapy or treatment with oral anticoagulant or aspirin may be considered”

January CT, et al. JACC 2014.

2019 AHA/ACC/HRS Update

January CT, et al. JACC 2019.

ESC Guidelines 2016

Kirchhof P, et al. Eur Heart J 2016.

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ESC Guidelines 2016

Kirchhof P, et al. Eur Heart J 2016.

ESC Guidelines 2016

Kirchhof P, et al. Eur Heart J 2016.

Anticoagulation in CHA2DS2-VASc =1 Patients

So What Should We Do?

  • Patient preference
  • Shared decision making
  • Consider bleeding risk
  • HAS-BLED score
  • 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?

Expert Opinion Based on Data

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  • 2015 analysis- 140,420 AF patients

(Swedish nationwide health registry) CHA2DS2-VASc score of 1

  • Annual event rates varied between 0.5 and 0.9

percent for stroke

  • Annual ischemic stroke rate was 0.1 to 0.2

percent for women (their CHA2DS2-VASc score

  • f 1 was derived from their sex)
  • Men, the annual ischemic stroke rate was 0.5

percent

Female Sex- Is it really 1 point?

Friberg L, et al. JACC 2015.

Aspirin Prescription in AF

Role in Stroke Risk Reduction

  • Antithrombotic therapy with warfarin

(and now NOACs) has been shown to:

  • Lower the risk of thromboembolism in patients

with AF

  • Effectiveness of Aspirin in reducing

stroke risk is debatable

Background

“With prior stroke, TIA, or CHA2DS2-VASc score of ≥2, OAC recommended including: warfarin, NOACs”

January CT, et al. JACC 2014.

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9/12/2019 8 “With nonvalvular AF and CHA2DS2-VASc score of 0, it is reasonable to omit antithrombotic therapy”

January CT, et al. JACC 2014.

“With nonvalvular AF and a CHA2DS2-VASc score of 1, no antithrombotic therapy or treatment with oral anticoagulant or aspirin may be considered”

January CT, et al. JACC 2014.

  • 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

Antiplatelet versus Placebo

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  • No study by itself shows benefit for

aspirin alone in preventing stroke in AF

  • Exception of the SPAF (Stroke Prevention in

Atrial Fibrillation) trial

Aspirin versus Placebo

Aspirin Use in Real- World Practice

Are we treating ourselves and not the patient?

Hsu JC, et al. JACC 2016.

38-40% of patients at moderate to high risk of stroke treated with Aspirin alone, not OAC!

Hsu JC, et al. Clin Pharmacol Ther. 2018.

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Hsu JC, et al. Clin Pharmacol Ther. 2018.

  • 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

Ntaios G, et al. Stroke 2017.

  • 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

LAAO for CHA2DS2-VASc =1

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  • AF patients with a CHA2DS2-VASc =1

may benefit from treatment with OAC, however the decision to treat is complex

  • OAC may be preferable over aspirin in

certain patients, but patient preference is important

Summary

THANK YOU

Email: Jonathan.Hsu@ucsd.edu Twitter: @JonHsuMD