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The risk discussion: A key virtue of the 2013 ACC/AHA cholesterol treatment guidelines
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by Seth S. Martin, MD; Neil J. Stone, MD; and Roger S. Blumenthal, MD
The 2013 American College of Cardiology/American Heart Association cholesterol treatment guidelines to reduce atherosclerotic CV risk empower clinicians and patients with critical knowledge to prevent fatal and nonfatal MI and stroke.
In the asymptomatic individual at risk for atherosclerotic CVD (ASCVD), a crucial element to effective implementation is the recommended “risk” discussion between the clinician and patient before a statin prescription is written. In our view, this aspect of the guideline has not received the attention that it deserves.
Value of the risk discussion
Guidelines are meant to inform clinical judgment, not to mandate care. Getting more patients and clinicians engaged in discussions to reduce overall ASCVD risk will be a major step forward.
The new guidelines specify that such a discussion should occur before starting a statin for primary prevention in adults with LDL cholesterol levels of 70 mg/dL to 189 mg/dL and estimated 10-year ASCVD risk of at least 5%. This is a patient–provider dialogue about potential benefits and harms of treatment, drug-drug interactions and patient preferences.
Seth S. Martin
Systematic reviews and meta-analyses of randomized clinical trials demonstrated benefit down to as low as 5% ASCVD risk, but 7.5% was inserted in the guidelines as the major recommended level of ASCVD risk to consider statin therapy. The authors acknowledged that even if the calculator overestimates true risk slightly, there is benefit below this cut point. The >5% cut point may be especially helpful in the young patient who wishes to address a strong family history of premature ASCVD.
This risk discussion of the 2013 ACC/AHA guidelines is consonant with a recent JAMA article by Montori and colleagues about the incorporation of patient preferences in guidelines. The authors stated: “Guidelines must not replace clinicians’ compassionate and mindful engagement of the patient in making decisions together. This is the optimal practice of evidence-based medicine.”
Such shared decision-making values the art of medicine, encouraging clinicians to personalize their patient interaction while reviewing all factors that contribute to the patient’s specific risk for ASCVD, as well as to their risk for adverse effects. It respects the autonomy of the individual with a focus on incorporating his or her preferences and enabling the patient to make a fully informed decision. Although the final decision is the patient’s, the clinician plays an important role.
For example, a major concern of some patients and clinicians is the possible accelerated development of clinical diabetes in asymptomatic patients if statins are given. The clinician can inform the patient of data from the JUPITER trial, in which researchers found that the more factors relating to diabetes onset that were present, the more likely patients were to develop diabetes with intensive statin therapy. Those factors included an HbA1c level ≥6%, fasting blood sugar ≥100 mg/dL, BMI ≥30 or metabolic syndrome. However, statin therapy appeared to accelerate the diagnosis to only 5 or 6 weeks earlier than it would have appeared with placebo. Importantly, in those without these diabetes risk factors, new diagnoses of diabetes were not seen.
Case example No. 1
To highlight the value of the risk discussion, two case examples may be illustrative.
First, consider a 74-year-old white woman with total cholesterol of 159 mg/dL, HDL cholesterol 62 mg/dL, Friedewald-estimated LDL cholesterol 77 mg/dL and untreated systolic BP 114 mm Hg. She does not have diabetes and smokes five cigarettes per day, as she has done for many years. The patient has a BMI of 18. Medications include a proton-pump inhibitor for reflux disease and periodic use of clarithromycin for treatment of recurrent sinusitis.
The patient has seen her clinician for more than 2 decades. The patient presents for routine follow-up and mentions that she read about the new cardiology guidelines and risk calculator. Trained as a statistician, she asks whether the clinician needs her help doing the calculations. They share a smile, and the clinician shows her the Excel-based calculator.
The clinician and patient calculate her estimated 10-year ASCVD risk at 16.6%, which is well above the 10.8% risk estimate for someone her age with optimal risk factors. The clinician notes that her risk estimate is more than triple the 5% risk threshold for considering statin therapy. However, the clinician points out that her high estimated risk is predominantly accounted for by her age and smoking. The clinician explains that her five cigarettes per day of smoking would not be anticipated to confer the same risk level as heavier smoking. She mentions that she does not inhale much, and asks the clinician to skip the discussion about smoking cessation. The clinician explains that her cholesterol levels are normal and that her BP measurement also is normal, only slightly higher (4 mm Hg) than optimal. The clinician notes that, in her case, statins would work by lowering her ASCVD risk, and that tobacco use is both a risk factor for ASCVD and cancer.
Yet, in the clinician’s best judgment, the risks for statin use may outweigh the long-term benefits. The clinician reasons that given the patient’s age, low body mass and potential for drug-drug interactions with the proton-pump inhibitor or clarithromycin, a significant net benefit seems unlikely in this patient with a normal cholesterol profile and overall near-optimal risk factors. The patient thanks the clinician and decides against statin treatment. The clinician then reinforces prior advice they had discussed on diet and activity.
Case examine No. 2
Next, consider a 46-year-old African-American man with total cholesterol of 215 mg/dL, HDL cholesterol 41 mg/dL, Friedewald-estimated LDL cholesterol 150 mg/dL and systolic BP 136 mm Hg. He is not on any medications. He does not have diabetes and has never smoked. His estimated 10-year ASCVD risk is 5.2% compared with 3.2% in someone his age with optimal risk factor levels. Given his 10-year ASCVD risk of ≥5%, the 2013 ACC/AHA guideline recommends a risk discussion with this patient.
Roger S. Blumenthal
To understand his potential benefits from starting a statin, the patient and his clinician also examine his estimated lifetime risk of ASCVD, which is 46% compared with 5% in someone with optimal risk factors at age 50 years. In discussing the patient’s family history, it is revealed that the patient’s father died at age 52 years; they “think it was a heart attack.” Highly motivated to avoid the same fate, the patient follows a very healthy lifestyle, stating that he does “all the right stuff.”
The clinician discusses the potential benefits and harms of statin therapy and answers the patient’s questions, as well as questions from his wife. The patient indicates that he prefers not to take medication, but is willing to consider a statin if the clinician strongly recommends it. The clinician points out that a history of early or premature MI may modify the patient’s actual ASCVD risk. The clinician introduces the option of obtaining a coronary artery calcium (CAC) score, noting that this is one of the factors that the guidelines suggest can be helpful when a risk decision is not certain.
The patient decides that he would like to obtain the CAC scan to better define his risk. The scan finds a CAC score of 312. The clinician informs the patient that this is evidence of severe plaque build-up, and that the score places him on par with someone who has already had an MI or stroke. At this point, the clinician strongly recommends statin therapy, and the patient decides to start high-intensity statin. The clinician prescribes an affordable generic prescription and recommends follow-up monitoring for therapeutic efficacy and safety; obtaining the best results will involve excellent adherence to both lifestyle and the statin prescription.
The ‘5 Ps’
As we enter the implementation phase of the guidelines, risk discussions such as these will occur with increased frequency. Depending on the knowledge of the clinician and the time available for discussion, patients may get different information.
As a basic framework, clinicians could consider “5 Ps”:
- Precision: How certain is the patient’s risk estimate and is further testing desired to be more precise?
- Participation: How motivated is the patient to participate in his or her ongoing care and improve lifestyle habits?
- Preference: What does the patient prefer based on his or her values and specific health concerns?
- Potency: What medication and intensity is proposed?
- Price: Although five of seven statins are generic, can the patient afford the proposed treatment?
Emphasis on prevention
Many clinicians will have differing ideas about how to carry out these discussions with patients. By focusing on the patient’s risk characteristics and their likelihood of adverse effects, the result will be improved understanding that translates into better adherence to both lifestyle improvements and, if prescribed, statin use. Figure 4 of the guideline indicated that the patient–clinician discussion was meant to occur before statin prescriptions were written in primary prevention. Since the CDC reminds us that CVDs, including heart disease and stroke, account for 33.6% of all US deaths, it is important to keep ASCVD prevention on the table for asymptomatic patients with patient–clinician discussions designed to focus lifestyle and statin treatment on those who would benefit most.
For more information:
Montori VM. JAMA. 2013;310:2503-2504.
Ridker PM. Lancet. 2012;380:565-571.
Stone NJ. J Am Coll Cardiol. 2013;doi: 10.1016/j.jacc.2013.11.002.
Seth S. Martin, MD, is a fellow at The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease and a member of the Cardiology Today Fellows Advisory Board. Neil J. Stone, MD, is the Bonow Professor of Preventive Cardiology at Northwestern University Feinberg School of Medicine and chair of the task force for the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. Roger S. Blumenthal, MD, is director of The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease and Section Editor of CHD and Prevention for Cardiology Today. He can be reached at rblument@jhmi.edu.
Disclosure: The authors report no relevant financial disclosures.