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S a n g e r H e a r t & Va s c u l a r I n s t i t u t e S y m p o s i u m 2 0 1 5
Cardiovascular Update For Primary Care Physicians
William E. Downey, MD FACC FSCAIMedical Director, Interventional Cardiology
Sanger Heart & Vascular Institute
New Lipid Management Guidelines: Lipids Meet Science
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Disclosures
None
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Multiple Guidelines
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2013 ACC/AHA Guideline Development: What data did they use?
• Randomized controlled trials with clinical endpoints published before 2012
– All of these compared relatively fixed doses of statins either to placebo or to other statins.
– No RCT data on a treat-to-target approach.
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Why focus on RCTs with clinical endpoints?
• Examples of discordant finding from observational and randomized studies:– Niacin and cardiovascular disease– Hormone replacement therapy and cardiovascular disease– Folate and cardiovascular disease– Vitamin E and cardiovascular disease– β-carotene and cardiovascular disease– β-carotene and cancer– Vitamin E and lung cancer– Bisphosphonates and breast cancer prevention– Statins for prevention of COPD exacerbations– Inhaled glucocorticoids for reduction in COPD mortality
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Who Benefits from LDL reduction?• Established clinical atherosclerosis (secondary prevention).
• Primary prevention in people with:– LDL ≥190.– Diabetes + age 40-75 + LDL ≥70.– Age 40-75 with estimated 10 year ASCVD risk ≥7.5%.
– Age 40-75 with estimated 10 year ASCVD risk ≥7.5%. Consider:• LDL ≥160• Family history of premature atherosclerosis• hsCRP ≥2 mg/dL• Coronary calcium score ≥300 or ≥75th %ile• ABI < 0.9
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Specific subgroups with insufficient data for recommendation
• CHF NYHA class II-IV
• Patients on hemodialysis
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Statin Risks
• Increased incidence of diabetes– Moderate intensity statin increases risk by 0.1/100 patient years– Moderate intensity statin increases risk by 0.3/100 patient years
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Statin Risks
• Myopathy– 0.01/100 patient years– JUPITER trial (rosuvastatin 20mg vs placebo)
• Muscle symptoms in 16.0% vs 15.4%
• Hemorrhagic stroke– 0.01/100 patient years
• Liver toxicity– Rare.– Check baseline ALT but no further monitoring unless symptoms
suggestive of liver disease develop.
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Intensity of statin therapy
High intensity statin Moderate intensity statin
Lowers LDL 50% Lowers LDL 30-50%
Atorvastatin 80 (40) mg daily Rosuvastatin 20 (40) mg daily
Atorvastatin 10-20mg daily Rosuvastatin 5-10mg daily Simvastatin 20-40mg daily Lovastatin 40mg dailyFluvastatin XL 80 mg daily Fluvastatin 40mg bid Pitavastatin 2-4mg daily
Source: Consumer Reports, High Cholesterol and Heart Disease, 2014
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2013 ACC/AHA Lipid Guidelines
• Simple
• Practical
• Data driven
• Patient Centric
S a n g e r H e a r t & Va s c u l a r I n s t i t u t e S y m p o s i u m 2 0 1 5
Cardiovascular Update For Primary Care Physicians
Cheryl Russo, MD, FACCAdult Cardiology
ACC/AHA Lipid Guidelines for Primary Prevention
Unvarnished Truth
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Disclosures
• None
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Discussion Strategies
1. Focus on what looks good.
2. Bash the subject.
3. Redirect attention to a better alternative.
4. Speak unvarnished truth.
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Areas of Concern
1. Risk Assessment
2. Randomized Controlled Trials
3. Exclusion of Groups
4. No Targets
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Risk Assessment
• Equations Gender/Race• Recommend Age 40• ASCVD and Stroke, not CHF
• Generation – Population changes: Smoking, Trans Fat, Medications
• MESA• Threshold Statin Treatment• Family History• Stroke
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Population Trends
Decreased Trans Fat• Decreased Smoking
• Decreased Trans Fat
• Increase in Preventive Medicine
• Increase in Preventive Medicine
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Framingham, Mass 1950
ATP-III Modified FRS
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American Diversity
Equations for non-Hispanic white, black and womenPooled data Framingham and offspring, ARIC, CHS, CARDIA
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MESA
• 6 Communities
• Men and Women 45-84 yr old
• 1/3 white, ¼ AA, ¼ Hispanic, 1/10 Asian
• Prevalence and Progression of Subclinical CV disease
• Improvement Risk Discrimination – Event Rate 0 RF/CAC >300 3.5X 3 RF/CAC 0
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Calcium Score
• Cheap
• 1mSv
• Predicts Risk Individual
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Statin Treatment Thresholds
High Risk• ATP-III >20% 10 yr risk• 10 yr risk of 7.5%
Intermediate Risk• ATP-III 10 yr risk 10-20%• 10 yr risk 5-7.5%
– Narrow, minimizes gains from imaging
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Family History
• We all ask about it
• Considered, did not improve models
• Did not distinguish premature CVD– Predictor of subsequent events– Canadian Cardiovascular Society Guidelines doubles risk
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Risk Assessment
• Refine with additional testing– Family history– CRP (>2)– Coronary Artery Calcium (>300, >75%ile)– ABI (<0.9)
• No evidence downgrade
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Stroke
• Risk Estimator more sensitive to age
• Leads to overtreatment– Example: 65 yr old white man, TC 150, HDL 50, SBP 120– 9.4%– RCT (AFCAPS) no benefit 40mg lovastatin
• 40% Stroke are of large vessel atherosclerotic source– Embolic– Hemorrhagic
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Randomized Controlled Trials
• Incorporate available data and draw conclusions
• “Perfect” RCT?
• Lifestyle interventions elsewhere
• Areas not adequately explored by RCT– Combined drug therapy– Patient groups
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Exclusion of Groups
• Metabolic Syndrome
• Elderly
• Inflammatory Disease
• Pre-eclampsia– 2011 AHA Women’s Guidelines – major risk factors
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Elderly
• No age cut off for intervention
• Increase risk threshold?
• SAGE– Study Assessing Goals in the Elderly
• PROSPER– Prospective Evaluation of Pravastatin in the Elderly
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No Target Goals
• How do we evaluate risk reduction?
• What is the patient’s goal?
• Performance Metrics based LDL targets
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Areas of Concern
1. Risk Assessment
2. Randomized Controlled Trials
3. Exclusion of Groups
4. No Targets
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Current under-treatment of hypercholesterolemia
Maddox et al. JACC 2014; 64: 2183
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How can we improve on this?
• Patient activation– Better education of risks and benefits
• Risk tools with visual explanations• Education tools• Financial education
• Clinical support– Pathways– Non-physician support
• Population management– Tableau
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Mayo Statin Decision Aid
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Statin Costs
High intensity statin Moderate intensity statin
Lowers LDL 50% Lowers LDL 30-50%
Atorvastatin 80 (40) mg daily ($18 Costco)Rosuvastatin 20 (40) mg daily ($207)
Atorvastatin 10-20mg daily ($17 Costco)Rosuvastatin 5-10mg daily ($201)Simvastatin 20-40mg daily ($4 Kmart, Walgreen, Costco)Lovastatin 40mg daily ($4 Target, Kmart, Walmart, Walgreen)Fluvastatin XL 80 mg daily ($217)Fluvastatin 40mg bid ($235)Pitavastatin 2-4mg daily ($180)
Source: Consumer Reports, High Cholesterol and Heart Disease, 2014
NB: Pill splitting halves cost for everything but top doses
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Medication-related financial advice
I can’t afford my statin!
$18 per month at Costco.
We need to know that in real time and prescribe accordingly.
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Pt name
Tableau
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Tableau
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Tableau
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Pro
vide
r N
ames
Tableau
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Lipid Management in the Future
• Outcome-driven
• Cost-conscious
• Population-based
• Patient Centric