Blood Pressure LIMBO

Joseph L. Kummer, MD, FACC

Bryan Health Primary Care Conference

May 19th, 2018

Blood Pressure LIMBOHow Low To Go?

• No financial disclosures

Disclosure Notice

• Office BP 155/95 mmHg

• What should be done?A) Nothing

B) Lifestyle Modifications

C) Recheck in Office in a Month

D) Have Pt check Home BP Readings

E) Start Pharmacologic Therapy

Case Scenario Question

• Multiple home BP readings obtained under appropriate conditions.

Average BP is 135/85 mmHg


B) Lifestyle Modifications and Reassess Periodically

C) Start Pharmacologic Therapy with Atenolol

D) Start Pharmacologic Therapy with Lisinopril

Case Scenario

• Over a billion people have hypertension worldwide, > 100 million in US

• In the US, 70% are aware of their disease, 59% are receiving treatment, and only 34% are adequately treated.

• Optimal BP goals are controversial. Need to balance benefits vs side effects, costs, and convenience of therapeutic interventions.

Hypertension Epidemiology

•Treating hypertension has been shown to:

•Reduce Stroke by 35‐40%

•Reduce Myocardial Infarction by 15‐25%

•Reduce Heart Failure by up to 64%

Hypertension Epidemiology

• Goal BP for an otherwise healthy adult• 140/90 mmHg

• With Diabetes or Renal Insufficiency • 130/80 mmHg

• Without a compelling indication, start medical therapy with a diuretic. Strongly consider initial therapy with two medications.

JNC-7 Guidelines (2003)

JNC VII Lifestyle Modifications for BP ControlModification Recommendation SBP Reduction

Weight Reduction Keep BMI 18.5‐24.9 kg/m2 5‐20 mmHg per 10kg Weight Loss

DASH Eating Plan Fruits, vegetables, low‐fat dairy; reduced saturated and total fat

8‐14 mmHg

Dietary Sodium Restriction 2.4 gm Na+ (6 gm NaCl) daily 2‐8 mmHg

Physical Activity At least 30 minutes aerobicactivity most days of the week

4‐9 mmHg

Moderate EtOHConsumption Up to 2 drinks/day for men, 1for women

2‐4 mmHg

Chobanian AV et al. JAMA. 2003;289:2560-2572

• ACCORD‐BP1

• Excellent trial design• 40‐79 year olds with Type II DM

• 4377 Subjects, 5 Year follow‐up (Released 2010)

• Known CAD (pre‐existing or subclinical) or at least two additional CAD risk factors

ACCORD Trial

1 The ACCORD Study Group. NEJM 2010; 362:1575-1585.

• ACCORD‐BP• Compared SBP goal < 120 mmHg to < 140 mmHg in these high risk diabetics

• Several medication combinations used

• Primary end point• Non‐fatal MI, Non‐fatal CVA, Cardiovascular Death

ACCORD Trial

• NO difference in major cardiac outcomes

• 40% lower absolute risk of non‐fatal stroke

• Higher risk of adverse events in the intensive treatment group• Hypotension, Renal Dysfunction, Hyperkalemia

ACCORD Trial

• Cardiac outcomes no better; fewer strokes offset by more complications, side effects

• Ultimately questioned BP Goals for diabetics and methodology for guidelines

• Less than or equal to 130 mmHg at the time

ACCORD Trial

• Released December, 2013

• Generally Higher (Less Intense) BP Goals

• Broadened initial BP med recommendations to 4 different categories

• Very strict trial criteria; only a handful of trials were included

• “Expert Opinion” was prevalently used

JNC-8

• In the general population ≥ 60 years of age, initiate pharmacologic treatment if SBP is ≥ 150 mmHg or DBP is ≥ 90 mmHg

• Strong Recommendation (Grade A)

• There is insufficient evidence to support a SBP less than 140 mmHg compared to a goal SBP below 150 mmHg

• Several panel members dissented and wanted a goal < 140 mmHg based upon Expert Opinion

Recommendation 1

• In the general population < 60 y/o, initiate pharmacologic therapy for DBP ≥ 90 mmHg

• For 30‐59 y/o, Strong Recommendation

• For 18‐29 y/o, Expert Opinion

• In the general population < 60 y/o, initiate pharmacologic therapy for SBP ≥ 140 mmHg

• Expert Opinion (Grade E)

Recommendations 2 & 3

• In the general adult population with CKD and DM, initiate pharmacologic therapy for SBP ≥ 140 mmHg or DBP ≥ 90 mmHg

• Expert Opinion (Grade E)

Recommendations 4 & 5

• Systolic Blood Pressure Intervention Trial

• A Randomized Trial of Intensive vs. Standard Blood‐Pressure Control. The SPRINT Research Group. NEJM. 373;22. Nov 26th, 2015

• https://www.sprinttrial.org

SPRINT Trial

• 9361 Enrolled

• At least 50 years old

• SBP ≥ 130 mmHg and ≤ 180 mmHg

• NOT Diabetic

• Increased Cardiovascular Risk

SPRINT Trial, Inclusion Criteria

• Goal SBP ≤ 120 mmHg

OR

• Goal SBP ≤ 140 mmHg

SPRINT Trial, Randomization

• Primary Outcome was a composite of:• Acute Myocardial Infarction/Other Acute Coronary Syndromes

• Heart Failure

• Stroke

• Death from Cardiovascular Causes

• Trial stopped after mean of 3.26 years of follow‐up due to improvement in primary outcome in Intensive‐Treatment group

• 2.19% Standard‐Treatment, 1.65% Intensive‐Treatment• HR 0.75. 95% CI [0.64‐0.89], P < 0.001

SPRINT Trial, Primary Outcome

SPRINT Results

• All‐Cause Mortality• HR 0.73. CI [0.60‐0.90], p < 0.003

• Relative Risk for Cardiac Mortality• 43% lower in the Intensive‐Treatment group

• 38% lower risk of Heart Failure with Intensive‐Treatment

SPRINT Trial, Results

• Adverse Reactions attributed to the treatment intervention were more common in the Intensive‐Treatment group

• Hypotension, Syncope, Electrolyte Abnormalities, Acute Kidney Injury• 4.7% vs. 2.5%. HR 1.88, p < 0.001

• Injurious falls and Bradycardia not more common

SPRINT Trial, Adverse Reactions

• Goal SBP < 120 mmHg vs < 140 mmHg in non‐diabetic patients at increased risk of CV events showed significant mortality and morbidity benefit with increase in relatively mild adverse events

SPRINT Conclusion

• 123 studies met criteria; 613,815 subjects

• Every 10 mmHg reduction in BP• Reduced Major Cardiac Events (RR 0.8)

• Reduced Coronary Events (RR 0.83)

• Reduced Stroke (RR 0.73)

• Reduced CHF (0.72)

• Reduced All‐Cause Mortality (RR 0.83)

• NO change in renal failure

The Lancet, Meta-Analysis

• Benefits seems to span across all baseline systolic blood pressures

• Benefit was seen across several baseline co‐morbidities (including CAD)

• Exceptions include DM and CKD, where the benefit was less clear


• B‐Blockers were inferior to other meds for CAD, CVA, CKD prevention

• Calcium Channel Blockers were worse in CHF but better for CVA prevention

• Diuretics were superior for preventing CHF


• “Blood pressure lowering significantly reduces vascular risk across various baseline blood pressure levels and comorbidities. Our results provide strong support for lowering blood pressure to systolic blood pressures less than 130 mm Hg.”


2017 ACC/AHA/AAPA/ABC/ACPM/AGS

/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood

Pressure in Adults

• http://hyper.ahajournals.org/content/hypertensionaha/early/2017/11/10/HYP.0000000000000065.full.pdf

• Hypertension. 2017; HYP.00000000‐00000066, November 13, 2017.

2017 Guidelines

• JNC‐7 released December 2003

• JNC‐8 released December 2013

• NHLBI develops JNC

• ACC and AHA have had independent guidelines since 1980

Collaboration of Societies

• In 2013, NHLBI (JNC) and ACC/AHA Task Force decided to partner with each other and several other societies to develop unified guidelines

• The present guidelines were formulated as part of the ongoing efforts the AHA/ACC Task Force in collaboration with NHLBI

• The new guidelines are essentially an update of JNC‐8 Guidelines

• SPRINT Trial likely a major reason for the present update

2107 Guideline Updates

Hypertension – Defined

SBP DBP

Normal < 120 mmHg and < 80 mmHg

Elevated 120‐129 mmHg and < 80 mmHg

Hypertension

‐ Stage 1 130‐139 mmHg or 80‐89 mmHg

‐ Stage 2 ≥ 140 mmHg or ≥ 90 mmHg

“Elevated” Blood Pressure – Purgatory?

• Increased risk of cardiac events and stroke starts at fairly low blood pressure

• Several meta‐analyses of observational data show the following:• RR of event is 1.1‐1.5 for SBP/DBP of 120‐129/80‐84 mmHg compared to < 120/80 mmHg

• RR of event is 1.5‐2.0 for SBP/DBP of 130‐139/85‐89 mmHg compared to < 120/80 mmHg

Hypertension - Defined

• Severe hypertension is still generally considered to be average BP > 160/100 mmHg

• This was not extensively addressed in the new guidelines

Hypertension - Defined

BP - 119/79 mmHg - Is this:

A. Normal

B. Elevated Blood Pressure

C. Stage 1 HTN

D. Stage 2 HTN

BP = 119/79 mmHg

Normal BP is SBP < 120 mmHg AND DBP < 80 mmHg


A. Normal


C. Stage 1 HTN

D. Stage 2 HTN

BP = 120/79 mmHg

“Elevated Blood Pressure” is SBP 120‐129 mmHg AND DBP < 80 mmHg


A. Normal


C. Stage 1 HTN

D. Stage 2 HTN

BP = 119/80 mmHg

Stage 1 Hypertension is SBP 130‐139 mmHg ORDBP 80‐89 mmHg

BP - 140/59 mmHg- Is this:

A. Normal


C. Stage 1 HTN

D. Stage 2 HTN

BP = 140/59 mmHg

Stage 2 Hypertension is SBP ≥ 140 mmHg OR DBP ≥ 90 mmHg

• SBP ≥ 130 mmHg or DBP ≥ 80 mmHg

• Pharmacologic therapy indicated for secondary prevention in those with CHD

• Indicated for primary prevention in adults with a 10 year atherosclerotic disease risk of 10% or higher

Medical Therapy


• Pharmacologic therapy indicated for secondary prevention in those with CHD

• Indicated for primary prevention in adults with a 10 year atherosclerotic disease risk of less than 10%

Medical Therapy

• SBP < 120 mmHg and DBP < 80 mmHg

• Optimal Lifestyle Habits

• Reassess Annually

Medical Therapy – Normal BP

• SBP 120‐129 mmHg and DBP < 80 mmHg

• Nonpharmacologic Therapy

• Reassess in 3‐6 Months

Medical Therapy – Elevated BP

• SBP 130‐139 mmHg or DBP 80‐89 mmHg

• Without Clinical CHD and 10‐year Risk < 10%• Nonpharmacologic Therapy

• Reassess in 3‐6 Months

• With Clinical CHD or 10‐year Risk ≥ 10%• Pharmacologic and Nonpharmacologic Therapy

• Reassess in 1 Month

• Reassess 3‐6 Months after BP Goal is Met

Medical Therapy – Stage 1 HTN


• Pharmacologic and Nonpharmacologic Therapy

• (Regardless of CHD or risk)

• Reassess in 1 Month

• Reassess 3‐6 Months after BP Goal is Met

Medical Therapy – Stage 2 HTN

• Remember Stage I HTN Systolic in 130s OR Diastolic in 80s

• Above this range Always treat

• Below this range Never treat

• In this range Treat higher risk only

Medical Therapy

• http://www.cvriskcalculator.com

• http://tools.acc.org/ASCVD‐Risk‐Estimator‐Plus/#!/calculate/estimate

ASCVD Risk Calculator

• Product of ACC and AHA

• Estimates 10 year risk of an atherosclerotic event

• Intended for those with LDL < 190 and only for those without known disease (primary prevention)


• Validated for those age 45 to 79

• For those above 79 y/o, 10‐year risk is generally > 10% regardless

• Clinical CVD is defined as:• Coronary Heart Disease

• Congestive Heart Failure

• Stroke


• Estimated risk of the following:• Nonfatal heart attack

• Death from coronary artery disease

• Fatal and nonfatal stroke


• Demographics• Age

• Gender (Male/Female)

• Ethnicity• Caucasian

• African American

• Other• May under or overestimate for different ethnicities


• Cholesterol Data• Total Cholesterol

• HDL

• LDL

• Blood Pressure• Systolic BP


• Personal History• Diabetes

• On Treatment for Hypertension

• Smoker• Yes, No, Former (When Quit)

• On a statin for high cholesterol

• On aspirin therapy


• Will estimate risk reduction with:• Smoking Cessation

• Start or intensify statin therapy

• Initiate blood pressure control medications

• Treat with Aspirin


• Provides advice on lifestyle and Medical Therapy changes• Diet and Exercise

• Salt Restriction, Potassium Supplementation

• Smoking Cessation

• Cholesterol/Statin Therapy

• Starting BP Meds


• Supposedly better than Framingham‐based assessment• Pooled cohort data

• More ethnic diversity

• Includes more outcomes


• Factors NOT included but may be relevant• Family History

• (1st Degree Male < 55, Female < 65)

• Elevated hsCRP

• Lifetime CVD Risk

• Coronary Calcium Score

• Ankle‐Brachial Index


• The new AHA/ACA guidelines defining HTN as 130/80 mmHg “raised” the prevalence in the US adult population from 32% to 46%

• In other words, the new definition just “gave” a disease to 50 million Americans

Prevalence

1) Properly prepare the patient

2) Use Proper Technique

3) Take the Proper Measurement

4) Properly Document Accurate Readings

5) Average the Readings

6) Provide BP Readings to the Patient

Measurement of Blood Pressure

• Increase of SBP of greater than 20 mmHg and diastolic greater than 10 mmHg

• This often decreases with familiarity with the clinician as well as throughout the office visit

• It is also less severe with nurses rather than doctors taking the BP reading

White Coat Hypertension

White Coat Hypertension

• Properly Prepare the Patient• Patient relaxed, sitting in a chair for at least 5 minutes

• Avoid caffeine, smoking, and exercise for 30 minutes prior to assessment

• Ensure the patient has emptied their bladder


• Properly Prepare the Patient• Neither patient not observer should talk during the rest period nor during assessment

• Remove all clothing covering the cuff area

• Patient should not be sitting or lying on an exam table


• Use Proper Technique• Use validated BP measurement device and make sure it’s calibrated properly

• Support the patient’s arm (resting on a desk)

• Position middle of cuff at level of right atrium (mid‐sternum)


• Use Proper Technique• Use proper cuff size (80% of bladder encircles the arm)

• Too small of a cuff falsely increases measurement

• Too big falsely lowers the reading

• Use either the bell or diaphragm of the stethoscope


• Take the Proper Measurement• At least at first visit, take BP in both arms and use higher reading from then on

• Wait 1‐2 minutes between repeat measurement

• Deflate cuff by 2 mmHg per second


• Properly Document Accurate BP Readings• Record SBP and DBP

• Note time of administration of last BP medications


• Average the Readings• Average of ≥ 2 readings obtained on ≥ 2 different occasions


• Provide BP Readings to the Patient• Provide SBP and DBP readings to patient both verbally and in writing


• ACC/AHA/AAPA/ABC/ACPM/AGS/‐APhA/ASH/ASPC/NMA/PCNA

• Notably absent is AAFP

AAFP?

• The American College of Physicians and American Academy of Family Physicians disagree with the ACC/AHA Guidelines

• They released their guidelines 1/17/2017

• Ann Intern Med. 2017;166(6):430‐437

ACP and AAFP

• AAFP announced in December 2017 that it does NOT endorse the ACC/AHA Guidelines

• The ACP and AAFP continue to endorse the 2014 JNC‐8 Guidelines

• https://www.aafp.org/patient‐care/clinical‐recommendations/non‐endorsed.html

Non-Endorsement

• Guidelines not based upon a sufficient systematic review of the evidence

• Only 4 key questions had a systematic review out of over 100 recommendations

• Harms of lower BP goals not systematically reviewed

Non-Endorsement Rationale

• The systematic review that was provided suggested a small benefit for lower BP goals in cardiac events but not mortality, MI, or renal events

• This review has similar conclusions to that performed for the ACP/AAFP Guidelines

• Therefore, AAFP recommends shared decision‐making with some patients about the risks vs benefits of BP management


• The recommendation statements included a grade for the strength of evidence, but assessments of the quality of individual studies or systematic reviews were not provided.


• Substantial weight was given to the SPRINT trial while results from other trials were minimized

• The SPRINT trial was stopped early due to benefit leading to the potential for exaggerated benefits and an under reporting of harms


• Conflicts of Interest

• The Chair of the SPRINT trial steering committee was commissioned as chair of the guideline panel

• Several other members of the panel also have intellectual conflicts of interest


• The new guidelines recommend the use of the ASCVD risk assessment tool to determine whether medications should be initiated for BP control

• This recommendation is not based on evidence that using the tool in this way improves outcomes


• Ann Intern Med. 2017;166(6):430‐437

• For adults 60 years and older

• Published March 2017

ACP and AAFP Guidelines

• Recommendation #1• Initiate medical therapy at SBP 150 mmHg with goal < 150 mmHg to reduce mortality, stroke, and cardiovascular events

• Discuss risks/benefits and BP goals with patient first


• Recommendation #2• Consider pharmacologic therapy with a goal of SBP < 140 mmHg for patients with a history of TIA or CVA to reduce risk of stroke

• (ACCORD Trial?)


• Recommendation #3• Consider pharmacologic therapy with a goal of SBP < 140 mmHg for patients with high cardiovascular risk, based on individualized assessment, to reduce risk of stroke or cardiac events





B) Lifestyle Modifications and Reassess Periodically

C) Start Pharmacologic Therapy with Atenolol


Case Scenario



• What should be done?A) X

B) X

C) X


Case Scenario

• Start Pharmacologic Therapy with Lisinopril• ACC/AHA Guidelines

• 10‐Year ASCVD Risk is 12%

• AAFP/ACP would generally only recommend Lifestyle Modifications• Shared Decision Making with the Patient about Medical Therapy

• Individualization of Therapy

Case Scenario

• Home BP Measurements are strongly encouraged

• Lifestyle Modifications for All

• Multiple medication choices (not changed from prior guidelines)

SUMMARY

• Goal BP for all healthy adults is:

• Less than 140/90 mmHg

• For those with CHD and those with ≥ 10% 10 year risk:

• Less than 130/80 mmHg

SUMMARY

…..FOR NOW!

SUMMARY

THANK YOU!!!!

Blood Pressure LIMBO

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