Blood Pressure LIMBO How Low To Go? Joseph L. Kummer, MD, FACC Bryan Heart Spring Conference April 21 st, 2018 Hypertension Epidemiology Over a billion people have hypertension Major cause of morbidity and mortality, much mediated through cardiovascular disease Optimal BP goals are controversial. Need to balance benefits vs side effects, costs, and convenience of therapeutic interventions Hypertension Epidemiology Over 60 million Americans have hypertension, a prevalence of about 3 of 10 adults About half of the US adult population older than 65 are hypertensive Of these, 70% are aware of their disease, 59% are receiving treatment, and only 34% are adequately treated 1
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% JNC-7 Guidelines (2003) 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 VII Lifestyle Modifications for BP Control Modification Recommendation SBP Reduction Weight Reduction Keep BMI 18.5-24.9 kg/m 2 5-20 mmhg per 10kg Weight Loss DASHEating Plan Fruits, vegetables, low-fat dairy;reduced saturated and total fat 8-14 mmhg DietarySodium Restriction 2.4 gm Na + (6 gm NaCl)daily 2-8 mmhg Physical Activity At least 30 minutes aerobic 4-9 mmhg activity most days of the week Moderate EtOHConsumption Up to 2 drinks/day for men, 1 for women 2-4 mmhg ChobanianAV et al. JAMA. 2003;289:2560-2572 2
ACCORD Trial ACCORD-BP 1 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 1 The ACCORD Study Group. NEJM 2010; 362:1575-1585. ACCORD Trial 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 No difference in significant renal failure or ESRD 3
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 JNC-8 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 Recommendation 1 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) 4
Recommendation 1 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 2 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 Recommendation 3 In the general population < 60 y/o, initiate pharmacologic therapy for SBP 140 mmhg Expert Opinion (Grade E) 5
Recommendation 4 In the general population 18 y/o with CKD, initiate pharmacologic therapy for SBP 140 mmhg or DBP 90 mmhg Expert Opinion (Grade E) Recommendation 5 In the general population 18 y/o with DM, initiate pharmacologic therapy for SBP 140 mmhg or DBP 90 mmhg Expert Opinion (Grade E) 6
SPRINT Trial Systolic Blood Pressure Intervention Trial A Randomized Trial of Intensive vs. Standard Blood-Pressure Control. The SPRINT Research Group. NEJM. 373;22. Nov 26 th, 2015 https://www.sprinttrial.org SPRINT Trial, Inclusion Criteria 9361 Enrolled At least 50 years old SBP 130 mmhg and 180 mmhg NOT Diabetic Increased Cardiovascular Risk SPRINT Trial, Inclusion Criteria Increased Cardiovascular Risk (1 or more) Clinical or subclinical cardiovascular disease other than stroke CRI with GFR 20 to 60 ml/min/1.73 m2 10-year risk of CAD 15% or higher on Framingham Risk Score Age 75 years Not Diabetic 7
SPRINT Trial, Randomization Goal SBP 120 mmhg OR Goal SBP 140 mmhg SPRINT Trial, Primary Outcome Primary Outcome was a composite of: Acute Myocardial Infarction Other Acute Coronary Syndromes Heart Failure Stroke Death from Cardiovascular Causes Secondary Outcome included Death from any Cause SPRINT Trial, Results After one year, Average Systolic BP: 121.4 mmhg in Intensive-Treatment group 136.2 mmhg in Standard-Treatment group 8
SPRINT Trial, Results After one year, Average Diastolic BP: 68.7 mmhg in Intensive-Treatment group 76.3 mmhg in Standard-Treatment group SPRINT Trial, Results Trial stopped after mean of 3.26 years of follow-up due to improvement in primary outcome in Intensive-Treatment group SPRINT Trial, Results Event Rates: 2.19% in Standard-Treatment group 1.65% in Intensive-Treatment group HR 0.75. 95% CI [0.64-0.89], P < 0.001 9
SPRINT Results SPRINT Trial, 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 New renal insufficiency (30% drop in GFR to < 60) in those without pre-existing CKD: 1.31% in Intensive-Treatment group 0.35% in Standard-Treatment group HR 3.49 10
SPRINT Trial, Adverse Reactions 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 SPRINT Trial, Adverse Reactions Adverse Reactions NOT more common in the Intensive-Treatment group included: Injurious Falls Bradycardia SPRINT Conclusion 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 11
Considerations Non diabetic patients only Different than ACCORD (Diabetics, no benefit) Minimal to no medication guidelines The Lancet, Meta-Analysis 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 12
The Lancet, Meta-Analysis 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 The Lancet, Meta-Analysis 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 and providing blood pressure lowering treatment to individuals with a history of cardiovascular disease, coronary heart disease, stroke, diabetes, heart failure, and chronic kidney disease. The Lancet, Meta-Analysis Authors Commentary This study calls for BP lowering to a greater extent than recommended in current guidelines As there was no lower BP threshold where benefit ceased, they recommended individualizing therapy based upon potential benefit, rather than universal BP goals 13
The Lancet, Meta-Analysis Authors Commentary, cont. They emphasized the benefit across multiple co-morbidities and in those both with and without vascular disease. Hence, guidelines could be simplified Lastly, they emphasized benefits of certain medications over the others based upon risk factors or known diseases 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 2017 Guidelines http://hyper.ahajournals.org/content/hypertensionaha/early/2017/1 1/10/HYP.0000000000000065.full.pdf Hypertension. 2017; HYP.00000000-00000066, November 13, 2017. 14
Collaboration of Societies JNC-7 released December 2003 JNC-8 released December 2013 NHLBI develops JNC ACC and AHA have had independent guidelines since 1980 2107 Guideline Updates 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 2107 Guideline Updates Comprehensive guideline review/updates every 6 years but also when new significant data arises The new guidelines are essentially an update of JNC-8 Guidelines SPRINT Trial likely a major reason for the present update 15
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 Hypertension - Defined 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 16
Medical Therapy SBP 130 mmhg or DBP 90 mmhg Pharmacologic therapy is indicated for secondary prevention in those with CVD Indicated for primary prevention in adults with a 10 year atherosclerotic disease risk of 10% or higher Medical Therapy SBP 140 mmhg or DBP 90 mmhg Indicated for primary prevention in adults with a 10 year atherosclerotic disease risk of less than 10% ASCVD Risk Calculator http://www.cvriskcalculator.com http://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate 17
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) ASCVD Risk Calculator Estimated risk of the following: Nonfatal heart attack Death from coronary artery disease Fatal and nonfatal stroke ASCVD Risk Calculator Demographics Age Valid for ages 40-79 Gender (Male/Female) Ethnicity Caucasian African American Other May under or overestimate for different ethnicities 18
ASCVD Risk Calculator Cholesterol Data Total Cholesterol HDL LDL Blood Pressure Systolic BP ASCVD Risk Calculator Personal History Diabetes On Treatment for Hypertension Smoker Yes, No, Former (When Quit) On a statin for high cholesterol On aspirin therapy ASCVD Risk Calculator Will estimate risk reduction with: Smoking Cessation Start or intensify statin therapy Initiate blood pressure control medications Treat with Aspirin 19
ASCVD Risk Calculator Provides advice on lifestyle and Medical Therapy changes Diet and Exercise Salt Restriction, Potassium Supplementation Smoking Cessation Cholesterol/Statin Therapy Starting BP Meds ASCVD Risk Calculator Supposedly better than Framingham-based assessment Pooled cohort data More ethnic diversity Includes more outcomes ASCVD Risk Calculator Factors NOT included but may be relevant Family History (1 st Degree Male < 55, Female < 65) Elevated hscrp Lifetime CVD Risk Coronary Calcium Score Ankle-Brachial Index 20
Prevalence 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 Measurement of Blood Pressure 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 White Coat Hypertension 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 21
White Coat Hypertension Measurement of Blood Pressure 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 Measurement of Blood Pressure 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 22
Measurement of Blood Pressure 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) Measurement of Blood Pressure 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 Measurement of Blood Pressure 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 For auscultatory measurements use radial artery obliteration first, then inflate 20-30 mmhg above this level Deflate cuff by 2 mmhg per second 23
Measurement of Blood Pressure Properly Document Accurate BP Readings Record SBP and DBP Onset of first Korotkoff sound and disappearance of all Korotkoff sounds Note time of administration of last BP medications Measurement of Blood Pressure Average the Readings Average of 2 readings obtained on 2 different occasions Measurement of Blood Pressure Provide BP Readings to the Patient Provide SBP and DBP readings to patient both verbally and in writing 24
AAFP? ACC/AHA/AAPA/ABC/ACPM/AGS/-APhA/ASH/ASPC/NMA/PCNA Notably absent is AAFP ACP and 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 Non-Endorsement 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/nonendorsed.html 25
Non-Endorsement Rationale 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 this Non-Endorsement Rationale 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. 26
Non-Endorsement Rationale 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 Non-Endorsement Rationale 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 Non-Endorsement Rationale The guideline recommends the use of the ASCVD risk assessment tool to determine whether medications should be initiated for BP control (strong recommendation). This recommendation is not based on evidence that using the tool in this way improves outcomes. 27
ACP and AAFP Guidelines 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 ACP and AAFP Guidelines 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 28
ACP and AAFP Guidelines 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 29