2013 Lipid Guidelines Practical Approach. Edward Goldenberg, MD FACC,FACP, FNLA Medical Director of Cardiovascular Prevention CCHS

Transcription

1 2013 Lipid Guidelines Practical Approach Edward Goldenberg, MD FACC,FACP, FNLA Medical Director of Cardiovascular Prevention CCHS

2 EVIDENCE BASED MEDICINE

3 Case #1 - LB 42 yo Asian/American female who was evaluated for asymptomatic PVCs. I took care of her father who had an MI in his 40 s and died in his 50 s. She had no additional CV risk factors Pex BMI 22 ; Waist 30 inches Labs: FBS 85, Cholesterol 191 mg %, Trigs 89mg%, HDL 53 mg%, LDL 120 mg%

4 Case #2 SK vs LE SK is a 58 yowf evaluated for fatigue which was felt to be secondary to stress. There were no other CV Risk Factors. Pex was normal and EKG were normal LE is a 66 yowf evaluated for an episode of nausea, bilateral arm heaviness and lightheadedness which lasted for 1 hour and left her fatigued for the next 2 days. Father had an MI in his 60 s Pex MSC and EKG was normal.

5 Case # 3do 52 year old white male jogger with a BMI of 25. During tax season he smokes. His father is blind as a complication of Diabetes Pex 130/85 Waist 35 in. BMI 25 Labs: Cholesterol 180mg% Triglycerides 150 mg% HDL 35 mg% LDL 115 mg% 10 year CV risk is 10.9%

6 Outline What is a Guideline? The New Risk Calculator 2013 Lipid Treatment Guidelines

7 Emerging from these documents and others is the sense that guidelines should inform, but not dictate, guide but not enforce, and support but not restrict Harlan M. Krumholz, MD JAMA April ;311;14;1403

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9 Standards for Developing Trustworthy Clinical Practice Guidelines Standard 5 Establishing evidence foundations for and rating strength of recommendations 5.1 For each recommendation, the following should be provided: An explanation of the reasoning underlying the recommendation, including: A clear description of potential benefits and harms. A summary of relevant available evidence (including applicability), quantity (including completeness), and consistency of the aggregate available evidence. An explanation of the part played by values, opinion, theory, and clinical experience in deriving the recommendation. A rating of the level of confidence in (certainty regarding) the evidence underpinning the recommendation. A rating of the strength of the recommendation in light of the preceding bullets. A description and explanation of any differences of opinion regarding the recommendation.

10 Level of Evidence

11 What is evidence based? Evidence based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. Evidence based is not restricted to randomized trials and meta analyses. It involves tracking down the best external evidence with which to answer our clinical questions. Sackett DL,Evidence based medicine: what it is and what it isn t. BMJ.1996;312:71-72

12 Risk Stratification

13 2013 ACC/AHA Cardiovascular Risk Guideline 1.3 Charge to the Work Group 1. To develop or recommend an approach to quantitative risk assessment that could be used to guide care; and 2. To pose and address a small number of questions judged to be critical to refining and adopting the risk assessment in clinical practice using systematic review methodology

14 Clinical Questions 1. What is the evidence regarding reclassification or contribution to risk assessment when high sensitivity CRP, ApoB, GFR, microalbuminuria, family history, fitness, ABI, CIMT or CAC are considered in addition to traditional risk scores 2. Are models constructed to assess the long term ( 15 years years or lifetime) risk for a first CVD event in adults effective in assessing variation in long term risk among adults at low and or intermediate short term risk, whether analyzed separately or combined

15 Cardiovascular Risk Calculator The work group decided not to use the prior risk calculator because it was derived in an exclusively White sample population and the limited scope of the outcome (CHD only) The risk equation is derived from community based cohorts (ARIC, CARDIA, CHS, FHS original and off spring) that are broadly representative of the U.S. population of Whites and African Americans, and focused on estimation of first hard ASCVD events (non fatal MI, CHD death, fatal or non fatal stroke) as the outcome of interest Coronary revascularization was not included.

16 Cardiovascular Risk Calculator In Asian Americans and Hispanic Americans there is an over estimation of risk In Native Americans there is an under estimation of risk In South Asians the risk is underestimated and should be multiplied by x the calculated risk (LOE E) Cardiovascular outcomes were confounded by the introduction of the aggressive use of aspirin and statins

17 AASCVD Risk Calculator TC-HDL=Non HDL

18 Non HDL-C Is a Stronger Predictor of CHD Risk than LDL-C The Framingham Study 2.5 Relative CHD risk N/A < < LDL C (mg/dl) Within non HDL C levels, no association was found between LDL C and the risk for CHD A strong, positive, and graded association between non HDL C and risk for CHD occurred within every level of LDL C CHD=coronary heart disease; HDL C=high density lipoprotein cholesterol; LDL C=low density lipoprotein cholesterol. Liu J, et al. Am J Cardiol. 2006;98:

19 Although based on a more diverse population with outcomes which include ASCVD, is the new Risk Calculator better? There are no RCT!

20 Points to Remember Cardiovascular Risk Stratification is NOT a perfect science YOU NEED TO BE A DOCTOR - Clinical Judgment is required! Evidence Based Medicine includes more than Randomized Controlled Trials (RCT) An absence of RCT does not mean that there is no information A recommendation for the care of a population may be different for the care of an individual patient

21 Treatment of Blood Cholesterol

22 This guideline focuses on treatments proven(rct) to reduce ASCVD events. It does not, and was never intended to be a comprehensive approach to lipid management

23 Critical Questions and Conclusions: CQ1: What is the evidence for LDL C and non HDL C for the secondary prevention of ASCVD? CQ2: What is the evidence for LDL C and non HDL C for the primary prevention of ASCVD? CQ3: For primary and secondary prevention, what is the impact on lipid levels, effectiveness, and safety of specific cholesterol modifying drugs used for lipid management in general and in selected subgroups?

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25 2013 ACC/AHA Guidelines for Use of Statins in Patients at Increased Cardiovascular Risk NEJM 2014;370: Keaney, JF

26 NHLBI E; ACC/AHA IIa;LOE B NEJM 2014;370: Keaney, JF

27 Summary of Statin Recommendation for Primary Prevention

28 Expert Opinion Thresholds for Use of Optional Screening Tests When Risk Decisions About Initiation of Pharmacological Therapy are Uncertain After Quantitative Risk Assessment

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30 Evidence was not found regarding the utility of lifetime risk assessment for guiding pharmacologic therapy decisions and may be used to motivate therapeutic lifestyle changes

31 Table 8. IAS Recommendations for Cholesterol-Lowering Therapy at Different Risk Levels Risk Level to age 80 yrs Low (<15%) Moderate (15-24%) Moderately High (25-40%) High (>40%) Therapeutic Intensity Moderate Moderately High High Specific therapy Public health recommendation a MLT b +CLD c optional d MLT b +CLD c consideration e MLT b +CLD c indicated f MLT Lifestyle CLD - Statins

32 Future Updates to the Blood Cholesterol Guidelines There are many clinical questions for which there is an absence of RCT data available to develop evidence based recommendations. For these questions expert opinion may be helpful Clinical Questions for future guidelines: the treatment of hypertriglycerides; use of non HDL C in treatment decision making; the best approaches to using non invasive imaging in refining risk estimates to guide treatment; whether on treatment markers such as ApoB, Lp(a), or LDL particles are useful for guiding treatment; how lifetime ASCVD risk should be used to inform treatment decisions and the optimal age for initiating statin therapy; Subgroups of patients with CHF or ESRD who might benefit from statins; Long term effects of statin associated new onset diabetes

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34 However if your LDL is > 70 you are treated!

35 Statin Therapy: Monitoring Therapeutic Response and Adherence

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37 A larger problem than who to treat is why aren t we treating the patients who are suppose to be treated!

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39 Case #1 - LB 42 yo Asian/American female who was evaluated for asymptomatic PVCs. I took care of her father who had an MI in his 40 s and died in his 50 s. She had no additional CV risk factors Pex BMI 22 ; Waist 30 inches Labs: FBS 85, Cholesterol 191 mg %, Trigs 89mg%, HDL 53 mg%, LDL 120 mg%

40 CV Risk Calculation- #1 What do we tell her?

41 Case #1 - LB 42 yo Asian/American female who was evaluated for asymptomatic PVCs. I took care of her father who had an MI in his 40 s and died in his 50 s. She had no additional CV risk factors Pex BMI 22; Waist 30 inches Labs: FBS 85, Cholesterol 191 mg %, Trigs 89mg%, HDL 53 mg%, LDL 120 mg% What do we do next? Family history doubles your risk but has little impact on the C statistic. Tell her there is nothing to worry about? Coronary Artery Calcium Score Advanced Lipid Testing

42 Advanced Lipid Testing Results - #1 LDL-P (nmol/l 2618 High Risk > 1300 sdldl ( mg%) 56 High Risk > 30 Lp(a) Mass (mg%) 12 High Risk >30 Lp(a) Chol (mg%) <3 High Risk > 6

43 Case #2 SK vs LE SK is a 58 yowf evaluated for fatigue which was felt to be secondary to stress. There were no other CV Risk Factors. Pex was normal and EKG were normal LE is a 66 yowf evaluated for an episode of nausea, bilateral arm heaviness and lightheadedness which lasted for 1 hour and left her fatigued for the next 2 days. Father had an MI in his 60 s Pex MSC and EKG was normal.

44 Case#2 LE vs SK LE SK 2014 Chol Trigs HDL LDL CV RISK % % What to do next?

45 CTA/CAC #2 LE: CAC=ZERO and CTA showed no evidence of soft plaque SK: CAC= 175 placing her in the 90 th % for age

46 Case #3 52 year old white male jogger with a BMI of 25. During tax season he smokes. His father is blind as a complication of Diabetes Pex 130/85 Waist 35 in. BMI 30 Labs: Cholesterol 180mg% Triglycerides 150 mg% HDL 35 mg% LDL 115 mg% 10 year CV risk is 10.9% Treat or Not? If he stops smoking he lowers his risk to 5.4% Dietary changes may correct his lipids