Donald M. Lloyd?Jones|Lynne T. Braun|Chiadi E Ndumele|Sidney C. Smith|Laurence Sperling|Salim S. Virani|Roger S. Blumenthal
Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology
homecirculationvol 139 25use risk assessment tools guide decisionmaking primary prevention atherosclerotic cardiovascular disease special report american heart association american college cardiology free accessreview articlepdfepubaboutview pdfview epubsections toolsadd favoritesdownload citationstrack citationspermissions shareshare onfacebooktwitterlinked inmendeleyreddit jump tofree accessreview articlepdfepubuse risk assessment tools guide decisionmaking primary prevention atherosclerotic cardiovascular disease special report american heart association american college cardiology donald lloydjones md scm facc faha lynne braun phd cnp faha chiadi e ndumele md pd faha sidney c smith jr md macc faha laurence sperling md facc faha salim virani md phd facc faha roger blumenthal md facc faha donald lloydjonesdonald lloydjones search papers author lynne braunlynne braun search papers author chiadi e ndumelechiadi e ndumele search papers author sidney c smith jrsidney c smith jr search papers author laurence sperlinglaurence sperling search papers author salim viranisalim virani search papers author roger blumenthalroger blumenthal search papers author originally published10 nov 2018httpsdoiorg101161cir0000000000000638circulation 2019139e1162e1177is corrected bycorrection use risk assessment tools guide decisionmaking primary prevention atherosclerotic cardiovascular disease special report american heart association american college cardiologyother versions articleyou viewing recent version article previous versions november 10 2018 ahead print abstractrisk assessment critical step current approach primary prevention atherosclerotic cardiovascular disease knowledge 10year risk atherosclerotic cardiovascular disease identifies patients higherrisk groups likely greater net benefit lower number needed treat statins antihypertensive therapy current us prevention guidelines blood pressure cholesterol management recommend use pooled cohort equations start process shared decisionmaking clinicians patients primary prevention pooled cohort equations widely validated broadly useful general us clinical population may systematically underestimate risk patients certain racialethnic groups lower socioeconomic status chronic inflammatory diseases overestimate risk patients higher socioeconomic status closely engaged preventive healthcare services uncertainty remains patients borderline intermediate risk patient undecided patientclinician discussion consideration risk enhancing factors eg family history additional testing measurement coronary artery calcium useful reclassify risk estimates improve selection patients use avoidance statin therapy special report summarizes rationale evidence base quantitative risk assessment reviews strengths limitations existing risk scores discusses approaches refining individual risk estimates patients provides practical advice regarding implementation risk assessment decisionmaking strategies clinical practiceintroductionfor 2 decades paradigm primary prevention atherosclerotic cardiovascular disease ascvd focused principle intensity prevention efforts match absolute risk patient12 patients regardless absolute risk appropriate lifestyle modification ie smoking cessation weight modification healthy dietary pattern participation physical activity recommended34 patients higher absolute predicted risk ascvd typically 10year estimated risk benefits medical therapy likely outweigh potential harm intensive lifestyle efforts consideration evidencebased preventive pharmacotherapy recommended1257 thus quantitative absolute risk assessment clinical practice assumed prominent role us international guidelines facilitate decisionmaking primary prevention159this special report summarizes rationale evidence base quantitative risk assessment reviews strengths limitations existing risk scores discusses approaches refining individual risk estimates patients provides practical advice regarding implementation risk assessment decisionmaking strategies clinical practice document intended serve companion 2018 accahaaacvpraapaabcacpmadaagsaphaaspcnlapcna guideline management blood cholesterol 2018 cholesterol clinical practice guidelines10 2017 accahaaapaabcacpmagsaphaashaspcnmapcna guideline prevention detection evaluation management high blood pressure adults 2017 hypertension clinical practice guidelines7quantitative risk assessment primary preventionrationaleestimation absolute risk developing incident cardiovascular disease cvd event foundation current approaches primary prevention cvd relative risk estimates disease incidence limited clinical utility given uncertainty regarding incidence rate referent group relative risk 10 may seem high incidence rate referent group near zero relative risk 10 still low absolute risk absolute risk estimation allows direct understanding prognosis identification patients sufficient risk merit treatment higher likelihood net individual societal benefit furthermore absolute risk estimation allows assessment potential benefits intensive lifestyle direct comparison potential benefits harms preventive pharmacotherapies assist clinicians patients informed decisionmaking substantial observational evidence support approach terms appropriate patient selection medical therapy maximizing net benefit minimizing numberneededtotreat prevent one event 5 10 years statins antihypertensive therapy1112 estimation absolute risk performed rapidly clinical practice widely available tools increasingly embedded electronic health record platforms decision support facilitating ease use implementationevidence basea recent comprehensive cochrane systematic review13 identified 41 randomized controlled trials examined use shortterm cvd risk estimation scores primary prevention authors found significant heterogeneity lowquality evidence trial results overall compared usual care providing quantitative cvd risk score data clinicians patients statistically significant modest effects levels cvd risk factors including total cholesterol systolic blood pressure sbp patients subsequent estimated 10year cvd risk followup providing risk information also associated increased initiation intensification lipidlowering antihypertensive medications also evidence harm quantitative risk assessment unlikely13because presently outcomes trials uncertainty remains whether current strategies providing quantitative cvd risk information directly reduce nearterm cvd event rates large clusterrandomized trial currently assessing impact cvd risk scorebased decisionmaking cvd event rates veryhighrisk medicare beneficiaries14 study clinical outcomes new models implementing optimizing delivery cvd risk scores clinical practice still needed define ultimate role primary prevention cvd meantime use validated quantitative risk assessment scores appears appropriate safe moderately efficacious helping control risk factors additional incurred costs assuming risk factors would measured anyway potential additional value improve decisionmaking described belowuse quantitative risk estimation current prevention guidelinesthe 2018 cholesterol clinical practice guidelines10 recommend use quantitative 10year risk assessment based measurement traditional ascvd risk factors use validated risk prediction tool first step considering treatment options primary prevention results 10year risk estimation communicated clinicianpatient risk discussion decide intensity preventive measures especially whether initiate medical therapy present guidelines patients estimated 10year ascvd risk 5 75 considered borderline risk may considered drug therapy statin certain circumstances intermediate 10year risk 75 20 considered initiation moderate highintensity statin therapy high 10year risk 20 considered initiation highintensity statin therapy10 clinical flow quantifying classifying risk considering riskenhancing factors discussing treatment options potentially reclassifying risk using coronary artery calcium cac measurement detailed belowin 2017 hypertension clinical practice guidelines7 quantitative risk estimation recommended guide intensity initial therapy patients stage 1 hypertension sbp 130139 mm hg diastolic blood pressure dbp 8089 mm hg patients stage 1 hypertension 10year ascvd risk estimate 10 managed initially nonpharmacological therapy whereas 10year risk 10 recommended initial management nonpharmacological approaches antihypertensive drug therapy7existing usderived risk scores cvd risk predictionpooled cohort equationsthe 2018 cholesterol clinical practice guidelines10 2017 hypertension clinical practice guidelines7 recommend use usderived pooled cohort equations pce5 estimate 10year risk hard ascvd events defined coronary death nonfatal myocardial infarction fatal nonfatal stroke pce designed sex racespecific whites blacks include stroke coronary heart disease endpoint better identify modifiable risk women blacks numerous investigators examined performance external validation samples1539 findings systematic review conducted 2018 cholesterol clinical practice guidelines included online data supplement guidelines10in general pce well calibrated near decision thresholds eg 75 10 10year ascvd risk equivalent individuals broad us population similarly men women performance pce diverse racialethnic groups outside united states highly variable would expected given heterogeneous nature populations differences prevalence risk factors differences underlying hazards ascvd1539clinical risk prediction scores attempt predict natural history disease incidence individuals based population levels risk factors underlying hazards less ideal accurate risk prediction patients already receiving intensive preventive efforts context pce noted well calibrated near decision thresholds large us general populations unselected clinical samples20303437 cvd risk scores overpredict underpredict risk samples see 2018 cholesterol clinical practice guidelines online data supplement10 findings mismatch predicted observed events ie miscalibration expected among homogeneous subgroups restricted risk distributions eg white women health professionals patients hiv considered use pce cvd risk score individual patientavailable data suggest clinicians consider pce may overestimate risk groups predicted 10year risk 10 higher socioeconomic status receiving consistent screening preventive care1517182126313537 general overprediction observed event rates documented situations validation sample affluent likely receive preventive drug therapy eg statins aspirin antihypertensive therapy longitudinal followup preventive services consistent overprediction also observed among high predicted risk strata particularly predicted 10year risks 10 may lesser clinical importance groups would likely benefit preventive medications precision risk estimate less essential number explanations overprediction advanced4041 including inadequate event capture validation cohorts well use older populationbased natural history cohorts derivation pce leading overprediction contemporary cohorts may exposed lower burden cvd risk factors beforeand certainly intensive preventive efforts afterinitial risk assessmentlikewise pce tend underpredict observed events samples lower socioeconomic status chronic inflammatory diseases hiv rheumatoid arthritis sarcoidosis17202336 thus context clinicianpatient discussion see clinicians consider pce may underestimate risk individuals lower socioeconomic status chronic inflammatory conditions work needed define additional conditions risk may underestimated riskenhancing factors including raceethnicity may modify 10year risk estimates described belowaccaha clinical practice guidelines710 recommend use pce important starting point final arbiter decisionmaking primary prevention ascvd quantitative risk assessment clinical judgment based individual patients preferences presence risk enhancers selective use cac scoring described help overcome issues miscalibration risk prediction equations approach help reclassify risk appropriately assist improved decisionmaking regarding use lipidlowering drug therapy ascvd risk reduction however data regarding appropriate tools eg echocardiography risk reclassification patients considered antihypertensive drug therapy neededuse risk scoresaccaha clinical practice guidelines recommend use quantitative risk assessment tools important step decisionmaking primary prevention ascvd whereas guidelines recommend using pce primary prevention patients except familial hypercholesterolemia lowdensity lipoproteincholesterol 190 mgdl risk assessment tools available tools validated broadly pce generally also perform moderately well discrimination calibration endpoints specifically designed table 1 presents features available usbased risk assessment tools include ascvd least part outcometable 1 features current usbased cardiovascular risk assessment toolsrisk assessment toolvariables includedoutcomes predictedderivation samplefeaturescomments implementationpooled cohort equationshttptoolsaccorgascvdriskestimatorpluscalculateestimate42httpsprofessionalheartorgprofessionalguidelinesstatementspreventionguidelinesucm457698ascvdriskcalculatorjsp43agesexracetotal cholesterolhdlcsbpantihypertensive therapyhistory diabetes mellituscurrent smokinghard ascvd chd death nonfatal mi fatal nonfatal stroke5 communitybased cohorts white black participantssex racespecific equations 4 groups white men white women black men black womenavailable appsonline electronic health record platformsuncertain utility racialethnic groupsdata available reclassification cac scoreframingham general cvd risk profilehttpsreferencemedscapecomcalculatorframinghamcardiovasculardiseaserisk44agesextotal cholesterolhdlcsbpantihypertensive therapyhistory diabetes mellituscurrent smokingtotal cvd chd death mi coronary insufficiency angina ischemic stroke hemorrhagic stroke transient ischemic attack intermittent claudication heart failuresingle communitybased cohort 2 generationssexspecific equations whitesavailable onlineuncertain utility racialethnic groupsuncertain calibration hard ascvd endpointuncertain reclassification cac scorereynolds risk scorehttpwwwreynoldsriskscoreorg4546agesextotal cholesterolhdlcsbpcurrent smokinghscrp levelparental history mi age 60 yexpanded ascvd chd death nonfatal mi fatal nonfatal stroke coronary revascularizationlargely white health professionals enrolled clinical trialssexspecific equationsavailable onlineuncertain utility racialethnic groupsuncertain calibration hard ascvd endpointuncertain reclassification cac scoreascvd indicates atherosclerotic cardiovascular disease cac coronary artery calcium chd coronary heart disease hscrp highsensitivity creactive protein cvd cardiovascular disease hdlc highdensity lipoprotein cholesterol mi myocardial infarction sbp systolic blood pressurethe framingham general cvd risk profile44 appears similar utility pce broad outcome includes ascvd events well unstable anginacoronary insufficiency transient ischemic attack claudication heart failure may directly preventable lipidlowering therapy reynolds risk score4546 appears perform somewhat better pce higher socioeconomic lowerrisk samples includes coronary revascularization endpoint features framingham reynolds risk assessment tools may limit implementation clinical practice regard alignment recommendations accaha clinical practice guidelines including uncertainty regarding use nonwhite patients calibration hard ascvd endpoint reclassification cac scoring european score systematic coronary risk evaluation algorithm9 less applicable general us population derived european samples given endpoint cvd death poor representation unpredictable calibration nonfatal cvd events47 qrisk algorithm predicting cardiovascular risk score8 calibrated general clinical population great britain uncertain value us samples reliable data available specific health system local population 10year follow recalibration may considered means improving accuracy risk equations populationspecial populationsquantitative risk assessment current risk scores performed patients clinical ascvd requires secondary prevention confirmed familial hypercholesterolemia baseline lowdensity lipoproteincholesterol 190 mgdl groups require intensive preventive efforts lipidlowering drug therapy given considerable risk future ascvd events similarly patients established diabetes mellitus considered statin therapy antihypertensive drug therapy blood pressure elevated regardless predicted 10year risk however 10year risk estimation may still useful patients diabetes mellitus inform thresholds initiation antihypertensive drug therapy intensity statin dosingbecause pce risk scores apply adults 40 75 years age limited data performance use quantitative 10year risk scores among adults 40 years age young age individuals would unlikely exceed 10year risk thresholds preventive drug therapy recommended48 discussed reasonable consider 30year lifetime risk estimation5 younger adults inform intensity prevention efforts adults 75 years age existing risk scores perform poorly 10year risk prediction weaker associations traditional risk factors events older ages competing risks noncardiovascular mortalityfor individuals racialethnic groups nonhispanic whites nonhispanic blacks accaha clinical practice guidelines recommend use pce versions whites sex37 context risk discussion clinicians consider pce may overestimate risk east asian eg chinese japanese hispanic white populations1621252839 groups appear somewhat lower ascvd risk nonhispanic white counterparts data sparse subgroups south asian eg indian pakistani populations appear somewhat higher risk49 issues context clinicianpatient discussion considered unless patient low 25 high 20 predicted risk pce case miscalibration unlikely affect clinical decisionmaking 45 adults 40 75 years age 10year ascvd risk estimates 5 205 consideration individual circumstances eg family history lifetime risk measurement cac score described may useful refine initial risk estimatelongterm lifetime risk assessmentguidelines5610 also promulgated use tools longterm lifetime risk assessment available httptoolsaccorgascvdriskestimatorpluscalculateestimate42 httpsprofessionalheartorgprofessionalguidelinesstatementsascvdriskcalculatorucm457698ascvdriskcalculatorjsp43 provide perspective longterm consequences single elevated clinical risk factors aggregate burden risk factor levels longer time horizon therefore lifetime risk assessment appears particularly useful describing communicating ascvd risk younger individuals 50 years age may high lifetime risk 10year risk may low even significant risk factors present young age 10year risk prediction window5054 example half us adult population 10year risk estimate 10 lifetime risk estimate 3953 date lifetime risk estimates generally recommended promote therapeutic lifestyle change younger individuals510 rather means patient selection drug therapy however indirect evidence benefit initiation statin therapy individuals lower 10year risk mean 10 high lifetime risk based inclusion criteria requiring least 1 additional cvd risk factor5052 seen hope3 heart outcomes prevention evaluation3 trial trial 10 mg rosuvastatin reduced cvd events compared placebo 37 versus 48 hazard ratio 076 95 confidence interval 064091 median 56 years followup55 trial statin versus placebo among younger individuals low shortterm high lifetime risk ongoing56 may inform potential use using lifetime risk assessment selection younger patients lipidlowering drug therapy simultaneous assessment 10year lifetime risks therefore reasonable purposes clinicianpatient discussion individual patientrefining risk assessment individual patients clinicianpatient discussionwhen considering drug therapy primary prevention ascvd clinicians patients begin calculating 10year lifetime ascvd risk estimates initial estimate form basis discussion includes consideration burden severity cvd risk factors control risk factors presence riskenhancing conditions see adherence healthy lifestyle recommendations potential ascvd riskreduction benefits statins antihypertensive drug therapy potential adverse effects drugdrug interactions well patient preferences regarding use medications primary prevention discussion patient health literacy numeracy important factors determining depth breadth content important factors include patients personal desire avoid stroke myocardial infarction potentially increase longevity countervailing issues desire avoid medicalization preventable conditions burden disutility taking daily frequent medications data including absolute 10year lifetime risk estimates relative absolute risk reduction benefit expected drug therapy even numbers needed treat 5 10 years prevent 1 ascvd event death may useful concepts address put context individual patients several tools documents exist may assist clinicians patients discussion includingaccs ascvd risk estimator plus tool predict 10year risk using pce project expected benefit different therapy choices eg initiation statin aspirin antihypertensive therapy smoking cessation primary prevention httpswwwaccorgascvdapp57mayo clinic shared decision making cardio vascular primary prevention choice tool httpsshareddecisionsmayoclinicorgdecisionaidinformationdecisionaidsforchronicdiseasecardiovascularprevention58a monograph martin et al59 describing conceptual framework practical implementation clinicianpatient discussion ortable 7 2018 cholesterol clinical practice guidelines10 provides framework tips clinicianpatient discussionin using tools important recognize quantitative 10year risk assessment provides estimates risk based group means largescale population studies course uncertainty around estimated probabilities creating distribution risk patients given risk estimate individual patient falls within distribution around estimated 10year risk depends large part factors included pce may considered clinician patient example 45yearold patient strong family history prematureonset ascvd likely higher risk patient age sex race risk factor profile without family history discussion concepts may assist eliciting patient preferences attitudes toward ascvd risk views drug therapy preventionthe 2018 cholesterol clinical practice guidelines10 identify riskenhancing factors comorbidities considered affect 10year risk estimate individual patients table 2 however difficult determine much riskenhancing factor comorbidity may change 10year risk estimate quantitatively individual patient therefore clinician judgment crucial determine whether presence riskenhancing factor significant enough reclassify individual higher lower risk category may cross treatment decision threshold consideration drug therapy clinicianpatient discussion benefits statin medication individual patient remain unclear patient important riskmodifying factors suggest better worse risk original estimate patient undecided regarding drug therapy additional testing help decision patients borderline 5 75 intermediate 10year risk 75 20 10year risk reasonable patients may also desire specific personal information guide decision demonstration presence absence condition interest ie advanced atherosclerosis presently best additional test help reclassify ascvd risk situations measurement cac score decisionmaking regarding statin therapy additional testing decisionmaking antihypertensive therapy may lower clinical utility60table 2 riskenhancing factors clinicianpatient risk discussion10 riskenhancing factors family history premature ascvd males age 55 females age 65 primary hypercholesterolemia ldlc 160189 mgdl 4148 mmoll nonhdlc 190219 mgdl 4956 mmoll metabolic syndrome increased w