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Aspirin for Primary Prevention: Helpful or Harmful? September 13, 2019 Hannah Gaylord, PharmD PGY-1 Pharmacy Resident Ascension Seton [email protected] 1

Aspirin for Primary Prevention: Helpful or Harmful? · Aspirin for Primary Prevention: Helpful or Harmful? Hannah Gaylord - PGY1 Pharmacy Resident 2 Objectives • Explain the role

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Page 1: Aspirin for Primary Prevention: Helpful or Harmful? · Aspirin for Primary Prevention: Helpful or Harmful? Hannah Gaylord - PGY1 Pharmacy Resident 2 Objectives • Explain the role

1

AspirinforPrimaryPrevention:

HelpfulorHarmful?September13,2019

HannahGaylord,PharmD

PGY-1PharmacyResident

AscensionSeton

[email protected]

1

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Aspirin for Primary Prevention: Helpful or Harmful? HannahGaylord-PGY1PharmacyResident

2

Objectives

•  Explaintheroleofaspirininprimarypreven7onofcardiovascularevents

•  Comparecurrentrecommenda7onsregardingaspirinforprimarypreven7onofcardiovasculareventstorecommenda7onsinpreviousguidelines

•  Analyzeprimaryliteraturesuppor7ngnewrecommenda7ons•  Applycurrentrecommenda7onstoapa7entcase

3

Abbreviations Ø  HTN-Hypertension

Ø  MI-Myocardialinfarc7on

Ø  NSAIDs-Nonsteroidalan7-inflammatorydrugs

Ø  PAD-Peripheralarterydisease

Ø  PMH-Pastmedicalhistory

Ø  PUD-Pep7culcerdisease

Ø  RR-Respiratoryrate

Ø  T2DM-TypeIIDiabetesMellitus

Ø  TIA-TransientischemicaNack

Ø  ACC-AmericanCollegeofCardiology

Ø  ACS-Acutecoronarysyndrome

Ø  AHA-AmericanHeartAssocia7on

Ø  ASCVD-Atherosclero7ccardiovasculardisease

Ø  BP-Bloodpressure

Ø  BPM-Beatsperminute

Ø  COPD-Chronicobstruc7vepulmonarydisease

Ø  DLD-Dyslipidemia

Ø  DOACs-Directoralan7coagulants

4

Patient Case

5

Per;nentPMH• HTN• T2DM• DLDFamilyHistory• T2DM

Allergies•  Penicillin

Per;nentSocialHistory• Tobaccouse:never• Alcoholuse:none

Patient Case – 65-Year-Old Female

6

Immuniza;onHistory• Uptodate

Patient Case – 65-Year-Old Female

CurrentMedica;ons• GlipizideXL10mgdaily•  Lisinopril20mgdaily• Rosuvasta7n20mgdaily• MeXormin1,000mgtwicedaily

2

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Patient Case – 65-Year-Old Female

Vitals•  BP:129/80•  Pulse:66BPM•  Temp:98.5°F•  RR:18• Wt:80kg•  Ht:165cm

AST:23ALT:24HgbA1c:6.5%LDL:69 136

4.7 2595

0.8

18100

37.1

6.811.3

185

10-yearASCVDrisk:10.2%

8

Should this patient receive aspirin?

9

Aspirin Use in ASCVD Prevention

10

Background

• 52%ofAmericans45-75yearsofagetakeaspirindaily

• Increasedfrom41%in2004• 12%ofthoseareforsecondarypreven7on• Otherreasonsfortakingdailyaspirin:

• Cancerpreven7on• Alzheimer’spreven7on

Williams, C., Chan, A., et al. Am J Prev Med 2015; 48(5), A4.

11

Background

• Aspirinisusedforpreven7onofASCVDeventsviaan7thrombo7ceffects

• Primarypreven7on• NopreviousASCVDevent• Benefit>risk?

• Secondarypreven7on• PreviousASCVDevent• Demonstratedbenefit>risk

Levine, G., Bates, E., Bittl, J., Brindis, R. et al. (2016). J Am Coll Cardiol. 68(10), 1082-1115.

12

Background

• Aspirinincreasestheriskofbleeding• Majorbleeding• GIbleeding•  Intracranialbleeding•  Especiallyinthose>70yearsofage

Levine, G., Bates, E., Bittl, J., Brindis, R. et al. (2016). J Am Coll Cardiol. 68(10), 1082-1115.

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Risk Factors for Bleeding

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. J Am Coll Cardiol.

•  Age>70years•  FemaleSex•  Lowbodyweight•  Thrombocytopenia•  Coagulopathy•  Anemia

•  HistoryofpreviousGIbleeding,PUD,bleedingatothersites

•  DiabetesMellitus•  Chronickidneydisease•  Concurrentuseofmedsthatincreasebleedingrisk(e.g.NSAIDs,steroids,DOACs,warfarin)

Levine, G., Bates, E., Bittl, J., Brindis, R. et al. (2016). J Am Coll Cardiol. 2010;55:2556–66.

Mehran R, Pocock SJ, Nikolsky E, et al. J Am Coll Cardiol. 2010;55:2556–66.

14

Aspirin Mechanism of Action

Shanmugalingam, R., Hennessy, A., & Makris, A. J Hum Hypertens 2018; 33(1), 1-9.

15

ASCVD Pathophysiology

LaMorte, W. Pathogenesis of Atherosclerosis. 2016.

16

ASCVD Risk Factors

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. J Am Coll Cardiol. Pearson, T., et al. (2002). Circulation, 106(3), 388-391.

Age Sex DiabetesMellitus

Total&HDLCholesterol SystolicBP Tobacco

use

17

ASCVD Risk-Enhancing Factors

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. J Am Coll Cardiol. Pearson, T., et al. (2002). Circulation, 106(3), 388-391.

•  Familyhistory•  Primaryhypercholesterolemia•  Metabolicsyndrome•  Chronickidneydisease•  Chronicinflammatorystates•  Prematuremenopause•  Race/ethnicity•  Otherlipidbiomarkers

18

ASCVD 10-Year Risk Score

• UsesASCVDriskfactorstodetermineriskoffutureevents

• Predictsthelikelihoodofaneventoverthenext10years

•  Low-risk(<5%)• Borderlinerisk(5%to7.4%)•  Intermediaterisk(7.5%to19.9%)• Highrisk(≥20%)

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. J Am Coll Cardiol.

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ACC/AHA 2019 Aspirin Recommendations

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. J Am Coll Cardiol.

20

Changes from Previous Guideline 2002AHACVDPreven;on 2019ACC/AHACVDPreven;on

Aspirinforprimarypreven7oninhighriskpa7ents-moderaterecommenda7on

Aspirinforprimarypreven7oninhighriskpa7ents-WEAKrecommenda7on

Aspirinforprimarypreven7oninpa7ents40-69yearsofagewith10-yearASCVDrisk>10%

Aspirinforprimarypreven7oninpa7ents40-69yearsofagewithhigherASCVDriskwithoutincreasedriskofbleeding

Ini7ateaspirinforprimarypreven7oninmostpa7entswithASCVDrisk>10%withoutfactorsthatincreaseriskofbleeding

Aspirinforprimarypreven7onshouldbeconsideredonanindividualizedbasisweighingbenefitsvs.risks

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. J Am Coll Cardiol. 2002 AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update.

21

Evidence Behind the Guidelines

22

ARRIVE Trial

• GazianoJM,etal.ARRIVETrial(n=12,546)•  AspirintoReduceRiskofIni7alVascularEvents•  Aspirin100mgdailyvs.placeboforprimarypreven7onofCVevents

•  Men>55andwomen>60yearsoldwith3ormoreriskfactorscorrespondingtoa10-20%10-yearASCVDrisk

•  Exclusions:Diabe;cs,increasedbleedrisk•  Primaryoutcome:compositeof7metofirstoccurrenceofCVdeath,MI,unstableangina,stroke,orTIA

Gaziano JM, Brotons C, Copolechhia R, et al. Lancet 2018;392:1036-46.

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Aspirin(n=6270) Placebo(n=6276)Meanage,years(SD) 63.9(7.1) 63.9(7.1)SexFemale 1851(29.5%) 1857(29.6%)Male 4419(70.5%) 4419(70.4%)RaceWhite 6133(97.8%) 6146(97.9%)Other 137(2.2%) 130(2.1%)Currentcigarettesmoker 1808(28.8%) 1786(28.5%)Medianweight,kg(IQR) 82.0(35-163) 82.0(43-177)MeanBMI(SD) 28.3(4.3) 28.5(4.3)HighLDL 2775(44.3%) 2869(45.7%)LowHDL 857(13.7%) 875(13.9%)Mediansystolicbloodpressure,mmHg(IQR) 145.0(80-199) 145.0(95-215)Takinganti-hypertensivemedications 4038(64.4%) 4097(65.3%)Mean10-yearASCVDriskscore(SD) 17.3%(9.8) 17.4%(9.7)

ARRIVE – Baseline Characteristics

Gaziano JM, Brotons C, Copolechhia R, et al. Lancet 2018;392:1036-46.

24

ARRIVE – Intention to Treat

OutcomeAspirin(n=6270)

Placebo(n=6276)

HazardRatio(95%CI) PValue

MI,stroke,CVdeath,unstableangina,TIA 269(4.29%) 281(4.48%) 0.96(0.81-1.13) 0.6038MI,stroke,CVdeath 208(3.32%) 218(3.47%) 0.95(0.79-1.15) 0.6190MI(fatalandnon-fatal) 95(1.52%) 112(1.78%) 0.85(0.64-1.11) 0.2325Non-fatalMI 88(1.40%) 98(1.56%) 0.90(0.67-1.20) 0.4562Stroke 75(1.20%) 67(1.07%) 1.12(0.80-1.55) 0.5072CVdeath 38(0.61%) 39(0.62%) 0.97(0.62-1.52) 0.0910Unstableangina 20(0.32%) 20(0.32%) 1.00(0.54-1.86) 0.9979TIA 42(0.67%) 45(0.72%) 0.93(0.61-1.42) 0.7455Anydeath 160(2.55%) 161(2.57%) 0.99(0.80-1.24) 0.9459

NumberofEventsinIntention-to-Treat

Gaziano JM, Brotons C, Copolechhia R, et al. Lancet 2018;392:1036-46.

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ARRIVE – Per Protocol

Outcome

Aspirin

(n=3790)

Placebo

(n=3912) HazardRatio(95%CI) PValue

MI,stroke,CVdeath,

unstableangina,TIA 129(3.40%) 164(4.19%) 0.81(0.64-1.02) 0.0756

MI,stroke,CVdeath 103(2.72%) 135(3.45%) 0.79(0.61-1.02) 0.0661

MI(fatalandnon-fatal) 37(0.98%) 72(1.84%) 0.53(0.36-0.79) 0.0014

Non-fatalMI 32(0.84%) 60(1.53%) 0.55(0.36-0.84) 0.0056

Stroke 40(1.06%) 37(0.95%) 1.12(0.71-1.75) 0.6291

CVdeath 26(0.69%) 26(0.66%) 1.03(0.60-1.77) 0.9161

Unstableangina 8(0.21%) 11(0.28%) 0.75(0.30-1.87) 0.0538

TIA 19(0.50%) 19(0.49%) 1.03(0.55-1.95) 0.9181

Anydeath 108(2.85%) 101(2.58%) 1.10(0.84-1.45) 0.4796

NumberofEventsinPer-Protocol

Gaziano JM, Brotons C, Copolechhia R, et al. Lancet 2018;392:1036-46.

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ARRIVE – Safety Outcomes

Outcome Aspirin(n=6270) Placebo(n=6276)Totalnumberofseriousadverseevents 1266(20.19%) 1311(20.89%)AnyGIbleeding 61(0.97%) 29(0.46%)SevereGIbleed 4(0.06%) 2(0.03%)ModerateGIbleed 15(0.24%) 5(0.08%)MildGIbleed 42(0.67%) 22(0.35%)Hemorrhagicstroke 8(0.13%) 11(0.18%)NumberofseriousadverseeventsperpersonOne 873(13.92%) 879(14.01%)Two 256(4.08%) 281(4.48%)Threeormore 137(2.18%) 151(2.41%)

Gaziano JM, Brotons C, Copolechhia R, et al. Lancet 2018;392:1036-46.

27

ARRIVE Trial - Critique and Conclusion

• Medianfollow-upof5years•  Eventratewasmuchlowerthanexpected(550vs.1488)–popula7onwaslowrisk

•  Inten7on-to-treatanalysisshowednosignificantchangeinrateofevents

• Conclusion:aspirinisprobablynotbeneficialinanintermediate-riskpopula7onofnon-diabe7cadults

Gaziano JM, Brotons C, Copolechhia R, et al. Lancet 2018;392:1036-46.

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ASCEND Trial

• ASCENDStudyCollabora7veGroup2018(n=15,480)

• Aspirin100mgdailyvs.placeboforprimarypreven7on

• Adults>40yearsoldwithdiabetes•  Exclusions:clearindica7onfororcontraindica7ontoaspirin

• Primaryoutcome:seriousvascularevent(nonfatalMI,nonfatalstroke,TIA,deathfromanyvascularcause)

ASCEND Study Collaborative Group. N Engl J Med 2018; 379:1529-1539.

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ASCEND – Baseline Characteristics

ASCEND Study Collaborative Group. N Engl J Med 2018; 379:1529-1539.

Aspirin(n=7740) Placebo(n=7740)Meanage,years(SD) 63.2(9.2) 63.3(9.2)SexFemale 2897(37.4%) 2899(37.5%)Male 4843(62.6%) 4841(62.5%)RaceWhite 7467(96.5%) 7468(96.5%)Other 273(3.5%) 272(3.5%)Currentcigarettesmoker 639(8.3%) 640(8.3%)AspirinUse 2740(35.4%) 2768(35.8%)StatinUse 5854(75.6%) 5799(74.9%)Type2diabetes 7282(94.1%) 7287(94.1%)Meansystolicbloodpressure,mmHg(SD) 136.1(15.2) 136.2(15.3)

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ASCEND – Efficacy Results

ASCEND Study Collaborative Group. N Engl J Med 2018; 379:1529-1539.

Aspirin(n=7740)

Placebo(n=7740) HazardRatio(95%CI) PValue

AnyseriousvasculareventexcludingTIA 542(7.0%) 587(7.6%) 0.92(0.82-1.03) NSAnyseriousvasculareventincludingTIA 658(8.5%) 743(9.6%) 0.88(0.79-0.97) 0.01Vasculardeathexcludingintracranialhemorrhage 197(2.5%) 217(2.8%) 0.91(0.75-1.10) NSTIA 168(2.2%) 197(2.5%) 0.85(0.69-1.04) NSAnyarterialrevascularization 340(4.4%) 384(5.0%) 0.88(0.76-1.02) NSAnyseriousvasculareventorrevascularization 833(10.8%) 936(12.1%) 0.88(0.80-0.97) NS

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Outcome

Aspirin

(n=7740)

Placebo

(n=7740) Ratio(95%CI) Pvalue

Anymajorbleeding 314(4.1%) 245(3.2%) 1.29(1.09-1.52) 0.003

Intracranialhemorrhage 55(0.7%) 45(0.6%) 1.22(0.82-1.81) NS

Sight-threateningeyebleed 57(0.7%) 64(0.8%) 0.89(0.62-1.27) NS

SeriousGIbleeding 137(1.8%) 101(1.3%) 1.36(1.05-1.75) NS

Othermajorbleeding 74(1.0%) 43(0.6%) 1.70(1.18-2.44) NS

ASCEND – Safety Results

ASCEND Study Collaborative Group. N Engl J Med 2018; 379:1529-1539.

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ASCEND – Critique and Conclusion

• Meanfollowupof7.4years•  Loweventrate• Mostpa7entsonasta7natbaseline• Conclusion:

•  Aspirinmayreduceincidenceofseriousvasculareventsindiabe7cpa7ents

•  Nonetbenefitduetoincreasedriskofbleeding

ASCEND Study Collaborative Group. N Engl J Med 2018; 379:1529-1539.

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ASPREE Trial

• McNeilJJ,etal.ASPREETrial2018(n=19,114)•  Aspirin100mgdailyvs.placeboforprimarypreven7on•  Adults>70yearsoldor>65yearsoldinBlackorHispanicpa7ents

•  Exclusions:includespa7entstakingan7coagulantoran7plateletmedica7on,pa7entswithBP>180/105mmHg,andmanyothers

•  Primaryoutcome:disability-freesurvival(all-causemortality,demen7a,orpersistentphysicaldisability)

McNeil JJ, Nelson MR, Woods RL, et al. N Engl J Med 2018; 379:1519-1528.

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ASPREE – Baseline Characteristics

McNeil JJ, Nelson MR, Woods RL, et al. N Engl J Med 2018; 379:1519-1528.

Aspirin(n=9525) Placebo(n=9589)Age>74years 4806(50%) 4766(50%)SexFemale 5373(56%) 5410(56%)Male 4152(44%) 4179(44%)RaceBlack 451(5%) 450(5%)Other 9074(95%) 9139(95%)Currentcigarettesmoker 352(4%) 383(4%)Diabetes 1027(11%) 1030(11%)Hypertension 7065(74%) 7148(75%)Dyslipidemia 6159(65%) 6308(66%)Numberofriskfactors0or1 2935(31%) 2885(30%)2 3968(42%) 4049(42%)3or4 2622(28%) 2655(28%)Statinuse 3244(34%) 3226(34%)NSAIDsuse 1371(14%) 1342(14%)Useofproton-pumpinhibitor 2340(25%) 2374(25%)

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ASPREE – Efficacy Results

McNeil JJ, Nelson MR, Woods RL, et al. N Engl J Med 2018; 379:1519-1528.

EndPointAspirin(n=7740)

Placebo(n=7740) HazardRatio(95%CI)

CVdisease 448(0.06%) 474(0.06%) 0.95(0.83-1.08)MajoradverseCVevent 329(0.04%) 372(0.05%) 0.89(0.77-1.03)FatalCVdisease 78(0.01%) 81(0.01%) 0.97(0.71-1.33)Hospitalizationforheartfailure 88(0.01%) 83(0.01%) 1.07(0.79-1.44)FatalornonfatalMI 171(0.02%) 184(0.02%) 0.93(0.76-1.15)Fatalornonfatalischemicstroke 148(0.02%) 167(0.02%) 0.89(0.71-1.11)

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ASPREE – Safety Results

McNeil JJ, Nelson MR, Woods RL, et al. N Engl J Med 2018; 379:1519-1528.

EndpointAspirin(n=9525)

Placebo(n=9589)

HazardRatio(95%CI) Pvalue

Majorhemorrhage 361(0.038%) 265(0.028%) 1.38(1.18-1.62) <0.001IntracranialbleedingHemorrhagicstroke 107(0.011%) 72(0.007%) 1.50(1.11-2.02) NSSubdural/extraduralhemorrhage 39(0.004%) 22(0.002%) 1.79(1.06-3.02) NSSubarachnoidhemorrhage 18(0.002%) 14(0.001%) 1.30(0.64-2.60) NSUpperGIbleeding 89(0.009%) 48(0.005%) 1.87(1.32-2.66) NSLowerGIbleeding 73(0.008%) 54(0.006%) 1.36(0.96-1.94) NSBleedingatanyothersite 101(0.011%) 88(0.009%) 1.16(0.87-1.54) NSFatalmajorhemorrhage 28(0.003%) 24(0.003%) 1.18(0.68-2.03) NSFatalhemorrhagicstroke 13(0.001%) 13(0.001%) 1.01(0.47-2.17) NS

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ASPREE – Critique and Conclusion

• Medianfollow-up:4.7years•  Extensiveexclusioncriteria•  TrialwasnotsetupforanalysisofmajorCVevents•  Significantlyhigherrateofbleedingeventsfound• Conclusion:Aspirinisprobablymoreharmfulthanhelpfulinhealthyelderlypa7ents

McNeil JJ, Nelson MR, Woods RL, et al. N Engl J Med 2018; 379:1519-1528.

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ARRIVE, ASCEND, ASPREE Summary ARRIVE ASCEND ASPREE

Popula7on Olderadultswith>3riskfactors(10-20%10-yearASCVDrisk)

Adults>40yearsofagewithdiabetesmellitus

Elderlyadults(>70yearsofage)

OutcomesStudied

Compositeoutcome:CVdeath,MI,unstableangina,stroke,TIA

Seriousvascularevent(nonfatalMI,nonfatalstroke,TIA,ordeathfromanyvascularcause)

Disability-freesurvival(all-causemortality,demen7a,orphysicaldisability)

Findings Nobenefitwithaspirinin5-yearfollowup;doubledriskofGIbleed

1.1%reduc7oninseriousCVevents;0.9%increaseinmajorbleed

Noreduc7oninCVeventswithsignificantincreaseinbleeding

Limita7ons Overalleventrateslowerthanexpected

Overalleventrateslowerthanexpected

Withexclusions,popula7onmostlyhealthyelderly

39

Abdelaziz, et al. Meta-Analysis – JACC

•  Included15randomizedcontrolledtrials• N=165,502• Meanfollowupof6years•  Efficacyoutcomesstudied:allcausedeath,CVdeath,MI,stroke,TIA,majoradversecardiacevents

•  Safetyoutcomesstudied:majorbleeding,intracranialbleeding,fatalbleeding,majorGIbleeding

Abdelaziz, et al. 2019. J Am Coll Cardiol. 73(23), 2915-2929.

40

Abdelaziz, et al. – Baseline Characteristics

Abdelaziz, et al. 2019. J Am Coll Cardiol. 73(23), 2915-2929.

• Heterogeneouspa7entpopula7on•  Age•  Presenceofdiabetes•  Presenceofotherriskfactorsandcomorbidi7es

• Differentstudydesignsandoutcomes•  Open-labelvs.blinded•  Outcomesvarying:stroke,CVevents,demen7a,death

•  Trialsspanningacrossdecades(1988–2018)

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Results – All Cause Death

Abdelaziz, et al. 2019. J Am Coll Cardiol. 73(23), 2915-2929.

42

Results – CV Death

Abdelaziz, et al. 2019. J Am Coll Cardiol. 73(23), 2915-2929.

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Safety – Major Bleeding

Abdelaziz, et al. 2019. J Am Coll Cardiol. 73(23), 2915-2929.

44

Abdelaziz, et al. – Critique and Conclusions

• Heterogeneouspa7entpopula7onandoutcomes• Aspirinassociatedwithsimilarall-causedeathandCVdeath

• Clearincreasesofmajorbleeding(mostlymajorGIbleeding;intracranialhemorrhage)

• Conclusion:aspirin’sbenefitremainsunclearandmaybecounterbalancedbyincreasesinbleedingrisk

Abdelaziz, et al. 2019. J Am Coll Cardiol. 73(23), 2915-2929.

45

Patient Case

46

Per;nentPMH• HTN• T2DM• DLDFamilyHistory• T2DM

Allergies•  Penicillin

Per;nentSocialHistory• Tobaccouse:never• Alcoholuse:none

Patient Case – 65-Year-Old Female

47

Patient Case – 65-Year-Old Female

Vitals•  BP:129/80•  Pulse:66BPM•  Temp:98.5°F•  RR:18• Wt:80kg•  Ht165cm

AST:23ALT:24HgbA1c:6.5%LDL:69 136

4.7 2595

0.8

18100

37.1

6.811.3

185

10-yearASCVDrisk:10.2%

48

Should this patient receive aspirin?

9

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Conclusions

• Aspirinshouldbeusedforprimarypreven7oninpa7ents40-69yearsofageplus:

•  StrongfamilyhistoryofprematureMI•  Unabletocontrolcomorbidi7esrelatedtoASCVD•  Noincreasedriskofbleeding

• Aspirinforprimarypreven7onisnotrecommendedinpa7ents>70yearsofage

•  Earlyiden7fica7onandaggressivetreatmentofASCVDriskfactorsarethebestdefenseagainstCVevents

50

Acknowledgements

•  RebekkaAdamson,PharmD,BCCP•  EvanPeterson,PharmD,BCPS,BCCP•  KathrynLiNen,PharmD

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Questions?

52

References •  2019ACC/AHAGuidelineonthePrimaryPrevenAonofCardiovascularDisease,JAmCollCardiol(2019).

•  AspirinforCVPrimaryPrevenAonandMore.Pharmacist'sLeKer.2018;DetailDocument#:341101.hKps://pharmacist.therapeuAcresearch.com/Content/Segments/PRL/2015/Nov/Aspirin-for-CV-Primary-PrevenAon-and-More-9083.AccessedJuly25,2019.

•  Pearson,T.,Blair,S.,Daniels,S.,Eckel,R.,Fair,J.,&Fortmann,S.etal.(2002).AHAGuidelinesforPrimaryPrevenAonofCardiovascularDiseaseandStroke:2002Update.CirculaAon,106(3),388-391.

•  MehranR,PocockSJ,NikolskyE,etal.AriskscoretopredictbleedinginpaAentswithacutecoronarysyndromes.JAmCollCardiol.2010;55:2556–66.

•  Levine,G.,Bates,E.,BiKl,J.,Brindis,R.etal.(2016).2016ACC/AHAGuidelineFocusedUpdateonDuraAonofDualAnAplateletTherapyinPaAentsWithCoronaryArteryDisease.JournalOfTheAmericanCollegeOfCardiology,68(10),1082-1115.

•  GazianoJM,BrotonsC,CopolechhiaR,etal.UseofaspirintoreduceriskofiniAalvasculareventsinpaAentsatmoderateriskofcardiovasculardisease(ARRIVE):arandomized,double-blind,placebo-controlledtrial.Lancet2018;392:1036-46.

•  ASCENDStudyCollaboraAveGroup.EffectsofaspirinforprimaryprevenAoninpersonswithdiabetesmellitus.NEnglJMed2018;379:1529-1539.doi:10.1056/NEJMoa1804988.

•  McNeilJJ,NelsonMR,WoodsRL,etal.Effectofaspirinonall-causemortalityinthehealthyelderly.NEnglJMed2018;379:1519-1528.doi:10.1056/NEJMoa1805819.

•  Mackman,N.,Spronk,H.,Stouffer,G.,&tenCate,H.DualAnAcoagulantandAnAplateletTherapyforCoronaryArteryDiseaseandPeripheralArteryDiseasePaAents.ArteriosclerThrombVascBiol2018;38(4),726-732.doi:10.1161/atvbaha.117.310048

•  Williams,C.,Chan,A.,Elman,M.,Kristensen,A.,Miser,W.,&Pignone,M.etal.InformaAonforCMECredit—AspirinUseAmongAdultsintheU.S.:ResultsofaNaAonalSurvey.AmericanJournalOfPrevenAveMedicine2015;48(5),A4.doi:10.1016/s0749-3797(15)00107-5

•  Abdelaziz,H.,Saad,M.,Pothineni,N.,Megaly,M.,Potluri,R.,&Saleh,M.etal.(2019).AspirinforPrimaryPrevenAonofCardiovascularEvents.JournalOfTheAmericanCollegeOfCardiology,73(23),2915-2929.doi:10.1016/j.jacc.2019.03.501

Aspirin for Primary Prevention: Helpful or Harmful? HannahGaylord-PGY1PharmacyResident

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AppendixAbbreviations

Ø ACC-AmericanCollegeofCardiology Ø ACS-Acutecoronarysyndrome Ø AHA-AmericanHeartAssociation Ø ASCVD-Atheroscleroticcardiovasculardisease Ø BP-Bloodpressure Ø BPM-Beatsperminute Ø COPD-Chronicobstructivepulmonarydisease Ø DLD-Dyslipidemia Ø DOACs-Directoralanticoagulants Ø HTN-Hypertension Ø MI-Myocardialinfarction Ø NSAIDs-Nonsteroidalanti-inflammatorydrugs Ø PAD-Peripheralarterydisease Ø PMH-Pastmedicalhistory Ø PUD-Pepticulcerdisease Ø RR-Respiratoryrate Ø T2DM-TypeIIDiabetesMellitus Ø TIA-Transientischemicattack

Coronaryheartdisease

Cerebrovasculardisease

Peripheralarterydisease

Aorticatheroscleroticdisease

Significantcoronaryarterystenosis

Significantcarotidarterystenosis

Claudication Abdominalaorticaneurysm

Angina Ischemicstroke Descendingthoracicaneurysm

MI TIA Table1.ASCVDincludedeventsandconditions.

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