sanger heart & vascular institute symposium 2015€¦ · sanger heart & vascular institute...

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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Sanger Heart & Vascular Institute Symposium 2015

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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Cardiovascular Update For Primary Care Physicians 2015

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

sanger heart & vascular institute symposium 2015€¦ · sanger heart & vascular institute...

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