New Paradigm (2017 Guidelines) for Blood Pressure ...
Transcript of New Paradigm (2017 Guidelines) for Blood Pressure ...
New Paradigm (2017 Guidelines) for Blood Pressure Treatment: Beyond the NumbersDonald M. Lloyd‐Jones, MD ScM FACC FAHAEileen M. Foell ProfessorChair, Dept. of Preventive MedicineSenior Associate DeanDirector, NUCATS InstituteNorthwestern Feinberg School of Medicine
Disclosures
•Dr. Lloyd‐Jones has no RWI/COIGrant funding: NIH, CMS, AHA
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Whelton et al. Circulation 2018; JACC 2018
ACC/AHA GuidelineRecommendations
•Class (Strength) of Recommendation I, IIa, IIb, III‐NB, III‐Harm
• Level (Quality) of Evidence A, B‐R, B‐NR, C‐LD, C‐EO
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BP Measurement and Classification
BP Measurement
•Prepare the patient (seated, feet on floor, arm supported) for >5 minsAvoid caffeine, exercise, smoking for > 30 mins prior
•Use appropriate cuff size•Measure in both arms at first visit (use higher value)•Average value of 2 or more readingsOn 2 separate occasions
• Inform the patient (verbal and written)
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Blood Pressure Classification – Updated!
•No more “pre‐hypertension”
• Stage 1 & 2 thresholds shifteddownward
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*Individuals with SBP and DBP in 2 categories should be designated to the higher BP category.
BP indicates blood pressure (based on an average of ≥2 careful readings obtained on ≥2 occasions, as detailed in DBP, diastolic blood pressure; and SBP systolic blood
pressure.
Why?
BP Category SBP DBP
Normal <120 mm Hg and <80 mm Hg
Elevated 120–129 mm Hg and <80 mm Hg
Hypertension
Stage 1 130–139 mm Hg or 80–89 mm Hg
Stage 2 ≥140 mm Hg or ≥90 mm Hg
Adjusted HRs for CVD by BP Groups, Age ≥50 y
Adjusted Hazard Ratio
<120/<80 mmHgSBP 120‐139 or
DBP 80‐89 mmHgSBP ≥140 or
DBP ≥90 mmHg
EndpointNo. Events
Untreated Treated Untreated Treated Untreated Treated
CVD 603 1.0 (ref) 2.2* 1.4* 2.2*† 2.8* 3.0*
CHD 423 1.0 (ref) 2.0* 1.3 2.1*† 2.3* 2.5*
HF 226 1.0 (ref) 1.7 1.4 2.4*† 2.4* 3.0*
Stroke 171 1.0 (ref) 2.6* 1.8 3.1* 4.2* 4.7*
MESA 9.5 Years of Follow‐Up
*P<0.01 compared with referent
†P<0.01 compared with treated, same BP Liu, JAHA 2015
Why? CARDIA BP Levels over 25 Years
Liu, JAHA 2015
Adjusted HRs for End Organ Damage by BP
Adjusted HR (95% CI)
<120/<80 mmHgSBP 120‐139 or
DBP 80‐89 mmHgSBP ≥140 or
DBP ≥90 mmHg
Subclinical Marker
Untreated Treated Untreated Treated Untreated Treated
Echo LVMI
g/m2.7 37.9 (ref) 39.9* 39.2* 42.2*† 43.0* 43.9*
CAC>100
% 5.3 (ref) 10.7* 7.9* 14.8*† 9.9* 12.7*
eGFR<60
% 0.8 (ref) 3.9* 0.6 2.1† 1.4 6.3*†
CARDIA Y25 Exam
*P<0.01 compared with referent
†P<0.01 compared with treated, same BP Liu, JAHA 2015
Adjusted for age, sex, race, BMI, smoking, diabetes, LDL-C, and cholesterol medication
Liu, JAHA 2015
Adjusted Relationship (Spline Regression) Between 25‐Year Cumulative SBP and LV Mass Index: CARDIA
3000 mm Hg‐years
= 120 mm Hg x 25 years
Implications of these Data
•Treatment back down to optimal BP levels does not restore low risk of those with always optimal BP
• Individuals exposed to higher BP, even within the “pre‐hypertensive” range, over time are accruing myocardial and vascular damage that is difficult if not impossible to reverse
Implicationsof New HTN Thresholds
•Prevalence of HTNincreases from 32% to 46% among US adults
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…But not all of these newly HTNsive pts require meds!
(~5% more)
Lifetime Risk of HTN by Thresholds
Chen et al, JAMA Cardiol 2019
Evaluation
Home and Ambulatory BP Monitoring
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COR
LOERecommendation for Out‐of‐Office and Self‐Monitoring of
BP
I ASR
Out‐of‐office BP measurements are recommended to confirm the diagnosis of hypertension and for titration of BP‐lowering medication, in conjunction with telehealth counseling or clinical interventions.
Home and Ambulatory BP Monitoring
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Detecting White Coat and Masked Hypertension
Screen for masked HTN
if target organ damage
Screen for white coat HTN
if target organ damage
Basic and Optional Testing for New‐Onset HTN
•BasicFBGLipidsSCr with eGFRU/ACBCTSHECG
•OptionalEchocardiogramUric acidUACR
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When to Screen for Secondary HTN
•New‐onset or uncontrolled HTN with:Abrupt onset Early onset (<30 yo)Onset of diastolic HTN in older adultUnprovoked or excessive hypoKAccelerated/malignant HTN Exacerbation of previously controlled HTNDrug‐resistanceDisproportionate TOD
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Cause Prevalence Clinical Indicators Screening TestsAdditional
Tests
Renal disease
1‐2%Abdominal mass; family hx
PCKD; ↑Cr; abnl U/ARenal U/S Renal w/u
Renovascu‐lar disease
5‐34%Resistant HTN; abrupt onset; flash pulmonary edema;
abdominal bruit; other bruits
Renal Duplex, MRA, CT
Angio
Primary hyperaldo
8‐20% Resistant HTN; ↓KPlasma aldo/renin ratio (K corrected; off ACEi/ARB 4 wks)
Sodium loading test –aldo; adrenal
CT
OSA 25‐50%Resistant HTN; obesity; snoring; somnolence
Epworth sleepiness PSG
Drug/EtOHinduced
2‐4%Caffeine; nicotine; EtOH; NSAIDs; OCPs; illicits
History; urinary drug screen
Withdraw agent
Common Causes of Secondary HTN
Uncommon Causes of Secondary HTN
•Pheochromocytoma/paraganglioma•Cushing’s syndrome•Hypothyroidism•Hyperthyroidism•Aortic coarctation (undiagnosed or repaired)•Primary hyperparathyroidism•Congenital adrenal hyperplasia•Mineralocorticoid excess syndromes other than primary aldosteronism•Acromegaly
Treatment
Lifestyle Modification for BP Lowering
Intervention GoalImpact on SBP
HTN NormoTN
Weight Weight lossIdeal body weight; 1 mm Hg/ 1 kg
‐5 mm Hg ‐2/3 mm Hg
Physical activity
Aerobic exercise
90‐150 min/wk ‐5/8 mm Hg ‐2/4 mm Hg
Dynamicresistance
90‐150 min/wk6 ex/3 sets/ 10 reps
‐4 mm Hg ‐2 mm Hg
Isometric resistance
4 x 2 min (hand grip) ‐5 mm Hg ‐4 mm Hg
EtOHmoderation
EtOHreduction
M: ≤2 drinks/dayW: ≤1 drink/day
‐4 mm Hg ‐3 mm Hg
All IA Recommendations
Dietary Modification for BP Lowering
Intervention GoalImpact on SBP
HTN NormoTN
Healthy dietDASH eating
pattern
Focus on fruits/veg/whole
grains/low‐fat dairy, ↓ sat and total fat
‐11 mm Hg ‐3 mm Hg
Dietary sodium
Reduced intake
<1500 mg/day; at least ↓ 1000 mg/day
‐5/6 mm Hg ‐2/3 mm Hg
Dietary potassium
Enhanced intake
3500‐5000mg/day thru dietary sources
‐4/5 mm Hg ‐2 mm Hg
All IA Recommendations
Initial Approaches to Therapy
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Thresholds for Initiating BP‐Lowering Drug Therapy
* Using Pooled Cohort Equations
COR LOERecommendations for BP Treatment Threshold and Use of Risk
Estimation* to Guide Drug Treatment of Hypertension
I
SBP: AUse of BP‐lowering medications is recommended for secondary prevention of recurrent CVD events in patients with clinical CVD and an average SBP of 130 mm Hg or higher or an average DBP of 80 mm Hg or higher, and for primary prevention in adults with an estimated 10‐year atherosclerotic cardiovascular disease (ASCVD) risk of 10% or higher and an average SBP 130 mm Hg or higher or an average DBP 80 mm Hg or higher.
DBP: C‐EO
I C‐LD
Use of BP‐lowering medication is recommended for primary prevention of CVD in adults with no history of CVD and with an estimated 10‐year ASCVD risk <10% and an SBP of 140 mm Hg or higher or a DBP of 90 mm Hg or higher.
Risk‐Based Approach to HTN Drug Treatment
• For the same SBP lowering,higher estimated CVD riskyields more events prevented per 1000 patients treated
BPLTTC
Risk‐ vs BP‐Based Approach to HTN Drug TreatmentBPLTTC
Karmali et al. PLoSMed 2018
Risk‐ vs BP‐Based Approach to HTN Drug TreatmentBPLTTC
Karmali et al. PLoSMed 2018
Risk‐ vs BP‐Based Approach to HTN Drug TreatmentBPLTTC
Karmali et al. PLoSMed 2018
But it is not “or”,
it is “and”…
Further Rationale
•RCTs have used other RFs to enhance risk of/increase events in eligible ppts and most have had 10‐year ASCVD risk >10%
• SPRINT included ppts with SBP >130 mm Hg and used general FRS >15% as inclusion criterion (~7% ASCVD risk)
•Meta‐analyses indicate that lowering of BP results in benefit in higher‐risk individuals, regardless of their baseline treated or untreated BP ≥130/80 mm Hg and irrespective of the specific cause of their elevated risk These analyses indicate that the benefit of treatment outweighs the potential harm at threshold BP ≥130/80 mm Hg.
Principles of Drug Therapy
•Primary AgentsThiazide diureticsACE‐inhibitorsARBsCCBs
•Secondary Agents Loop diuretics Potassium sparing diuretics Aldosterone antagonists Beta‐blockers Direct renin inhibitor (aliskiren) Alpha1‐blockers Central alpha2‐agonist (clonidine) Direct vasodilators (hydralazine, minoxidil)
Principles of Drug Therapy
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COR LOE Recommendation for General Principle of Drug Therapy
III: Harm ASimultaneous use of an ACE inhibitor, ARB, and/or renin inhibitor is potentially harmful and is not recommended to treat adults with hypertension.
COR LOERecommendations for Choice of Initial Monotherapy Versus Initial
Combination Drug Therapy*
I C‐EO
Initiation of antihypertensive drug therapy with 2 first‐line agents of different classes, either as separate agents or in a fixed‐dose combination, is recommended in adults with stage 2 hypertension and an average BP more than 20/10 mm Hg above their BP target.
IIa C‐EO
Initiation of antihypertensive drug therapy with a single antihypertensive drug is reasonable in adults with stage 1 hypertension and BP goal <130/80 mm Hg with dosage titration and sequential addition of other agents to achieve the BP target.
Follow Up
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COR LOERecommendations for Follow‐Up After Initiating Antihypertensive
Drug Therapy
I B‐R
Adults initiating a new or adjusted drug regimen for hypertension should have a follow‐up evaluation of adherence and response to treatment at monthly intervals until control is achieved.
BP Goals for Patients with HTN
COR LOE Recommendations for BP Goal for Patients With Hypertension
I
SBP:B‐RSR For adults with confirmed hypertension and known CVD or 10‐
year ASCVD event risk of 10% or higher a BP target of less than 130/80 mm Hg is recommended. DBP: C‐
EO
IIb
SBP:B‐NR
For adults with confirmed hypertension, without additional markers of increased CVD risk, a BP target of less than 130/80 mm Hg may be reasonable. DBP: C‐
EO
Systolic Blood Pressure Intervention Trial (SPRINT)
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• Background• Clinical trials demonstrate antihypertensive drug therapy reduces risk of CVD.
• However, optimal target for SBP lowering uncertain. Most guidelines target SBP <140 mm Hg based on limited evidence.
• A prior trial aiming for SBP <120 mm Hg (vs. <140 mm Hg) in diabetics showed null effect, less stroke, more harm.
• Objective: Compare the benefit of treatment of systolic blood pressure to a target of less than 120 mm Hg with treatment to a target of less than 140 mm Hg in non‐diabetic patients
SPRINT Background/Rationale
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Participants: Age 50+, SBP 130‐180, and ↑ risk for CVD‐ Clinical or subclinical CVD (not stroke or active CHF); CKD; 10‐year CVD risk ≥15%; or age 75+; excluded those with DM
Intervention: Target SBP <120 mm Hg
Comparator: Target SBP <140 mm Hg
Outcomes: 1o: Composite of MI, ACS, Stroke, Acute decompensated HF, CVD death; 2o: Primary components, total mortality
Time Course: Planned 5‐year average follow up; stopped early after 3.3 years for total mortality benefit
Setting: 102 centers in US and Puerto Rico
Funded by NIH
SPRINT PICOTS
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SPRINT ‐ Baseline Characteristics
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Intensive(N=4678)
Standard(N=4683)
Age, years (SD) 67.9 (9.4) 67.9 (9.5)
Women, % 36.0% 35.2%
Black race, % 31.1% 31.9%
SBP, mean (SD) 139.7 (15.8) 139.7 (15.4)
Clinical CVD, % 16.7% 16.7%
FRS 10‐y CVD risk, mean (SD) 20.1 (10.9) 20.1 (10.8)
Creatinine, mean (SD) 1.07 (0.34) 1.08 (0.34)
BP‐lowering drug use, % 90.8% 90.4%
SPRINT Trial – SBPs Achieved
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Mean SBP136.2 mm Hg
Mean SBP121.4 mm Hg
Year 1
SPRINT Trial ‐ Outcomes
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Number needed to treat
to prevent 1 outcome / 3.3 years
= 60
Number needed to treat
to prevent 1 death / 3.3 years
= 83
SPRINT Trial
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Intensive vs Standard BP Lowering Goal for High‐Risk HTN
Intensive (<120 mmHg)
Standard (<140 mm Hg)
No. of Events
Rate, %/year
No. of Events
Rate, %/year
HR (95% CI) P
Primary Outcome
243 1.65 319 2.19 0.75 (0.64, 0.89) <0.001
All MI 97 0.65 116 0.78 0.83 (0.64, 1.09) 0.19
Non‐MI ACS
40 0.27 40 0.27 1.00 (0.64, 1.55) 0.99
All Stroke 62 0.41 70 0.47 0.89 (0.63, 1.25) 0.50
All HF 62 0.41 100 0.67 0.62 (0.45, 0.84) 0.002
CVD Death
37 0.25 65 0.43 0.57 (0.38, 0.85) 0.005
SPRINT Trial – Prespecified Subgroup Analyses
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SPRINT Trial – Adverse Events
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SPRINT – Strengths/Limitations/Conclusions
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Strengths: Large, diverse sample; achieved SBP separation.
Limitations: No DM or stroke pts; method of BP measurement not usual for clinical practice.
Conclusions: Targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, in patients at high risk for cardiovascular events but without diabetes resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause. However, some adverse events occurred significantly more frequently with the lower target.
Comorbid Conditions and Special Populations
BP Goals for Patients with HTN
Clinical Condition(s)BP Threshold,
mm Hg
BP Goal,
mm Hg
General
No clinical CVD and 10‐year ASCVD risk <10% ≥140/90 <130/80
Clinical CVD or 10‐year ASCVD risk ≥10% ≥130/80 <130/80
Older persons (≥65 years of age; noninstitutionalized,
ambulatory, community‐living adults)
≥130 (SBP) <130 (SBP)
Specific comorbidities
Diabetes mellitus ≥130/80 <130/80
Chronic kidney disease ≥130/80 <130/80
Chronic kidney disease after renal transplantation ≥130/80 <130/80
With or at risk for heart failure (HFrEF or HFpEF) ≥130/80 <130/80
Stable ischemic heart disease ≥130/80 <130/80
Secondary stroke prevention ≥140/90 <130/80
Secondary stroke prevention (lacunar) ≥130/80 <130/80
Peripheral arterial disease ≥130/80 <130/80
Patients with CKD
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Secondary Stroke Prevention
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Patients with Diabetes Mellitus
COR LOERecommendations for Treatment of Hypertension in Patients
With DM
I
SBP:B‐RSR In adults with DM and hypertension, antihypertensive drug
treatment should be initiated at a BP of 130/80 mm Hg or higher with a treatment goal of less than 130/80 mm Hg.
DBP: C‐EO
I ASR
In adults with DM and hypertension, all first‐line classes of antihypertensive agents (i.e., diuretics, ACE inhibitors, ARBs, and CCBs) are useful and effective.
IIb B‐NRIn adults with DM and hypertension, ACE inhibitors or ARBs may be considered in the presence of albuminuria.
African‐American Patients
COR LOE Recommendations for Race and Ethnicity
I B‐RIn black adults with hypertension but without HF or CKD, including those with DM, initial antihypertensive treatment should include a thiazide‐type diuretic or CCB.
I C‐LDTwo or more antihypertensive medications are recommended to achieve a BP target of less than 130/80 mm Hg in most adults with hypertension, especially in black adults with hypertension.
Management in Pregnancy
COR LOE Recommendations for Treatment of Hypertension in Pregnancy
I C‐LDWomen with hypertension who become pregnant, or are planning to become pregnant, should be transitioned to methyldopa, nifedipine, and/or labetalol during pregnancy.
III: Harm C‐LDWomen with hypertension who become pregnant should not be treated with ACE inhibitors, ARBs, or direct renin inhibitors.
Management of Older Patients
COR LOERecommendations for Treatment of Hypertension in Older
Persons
I A
Treatment of hypertension with a SBP treatment goal of less than 130 mm Hg is recommended for noninstitutionalized ambulatory community‐dwelling adults (≥65 years of age) with an average SBP of 130 mm Hg or higher.
IIa C‐EO
For older adults (≥65 years of age) with hypertension and a high burden of comorbidity and limited life expectancy, clinical judgment, patient preference, and a team‐based approach to assess risk/benefit is reasonable for decisions regarding intensity of BP lowering and choice of antihypertensive drugs.
Strategies to Improve HTN Treatment and Control
Adherence Strategies
COR LOERecommendations for Antihypertensive Medication Adherence
Strategies
I B‐RIn adults with hypertension, dosing of antihypertensive medication once daily rather than multiple times daily is beneficial to improve adherence.
IIa B‐NRUse of combination pills rather than free individual components can be useful to improve adherence to antihypertensive therapy.
Plan of Care and Team‐Based Care
COR LOERecommendation for Structured, Team‐Based Care
Interventions for Hypertension Control
IC‐EO
Every adult with hypertension should have a clear, detailed, and current evidence‐based plan of care that ensures the achievement of treatment and self‐management goals, encourages effective management of comorbid conditions, prompts timely follow‐up with the healthcare team, and adheres to CVD GDMT.
IA
A team‐based care approach is recommended for adults with hypertension.
Summary and Take Home Points
•Measure BP correctly in office and measure it more out of office•New threshold for dx of HTN: SBP ≥130 or DBP ≥ 80 mm Hg• Lifestyle and dietary approaches are very effective for all •Treat when BP ≥140/90, or ≥130/80 with ASCVD risk ≥10%•Primary agents: Thiazide, ACEi, ARB, CCB•Consider other agents with comorbid conditions•Consider 2 or more drugs and combinations to maximize BP lowering while minimizing side effects, esp. for Stage 2 HTN (≥140/90 mm Hg)
•Goal BP is <130/<80 mm Hg for (essentially) all•Adherence strategies and team‐based care are key