CHICAGO – The world of cholesterol management and coronary heart disease prevention has come a long way since 2013, when an important practical guidance document called for radical changes in strategies to reduce LDL cholesterol (LDL-C), praising, reproaching and perplexing.
The latest incarnation of this document, unveiled here at the scientific sessions of the American Heart Association (AHA) 2018, preserves the key ideas from the original and puts a renewed focus on principles cherished by a seat in 2013.
In addition, the AHA / American College of Cardiology (ACC) 2018 guideline on blood cholesterol management provides concrete guidance on the use of proprotein convertase subtilisin / kexine type 9 inhibitors (PCSK9), or evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi / Regeneron).
The 2018 guideline preserves one of the most controversial innovations of the 2013 document, a 10-year atherosclerotic cardiovascular disease (ASCVD) scoring system, but modified it to include more population-based data than before. But more fundamentally, it seems to reduce the influence of the ASCVD risk calculator as a trigger for statin therapy.
To a large extent the height of the influence is limited to the restoration of LDL-C treatment objectives, especially in the higher risk groups, and a pervasive investment in the patient-doctoral communication for the shared decision-making process, especially for primary prevention at intermediate risk.
In this last group, the coronary artery (CAC) scores are kept for limited use as a potential "tie-breaker" in the decision-making process of statins or not.
The guideline recommends PCSK9 inhibitors, whose randomized pillars were established after 2013, mainly for patients with familial hypercholesterolemia (FH) and for patients with very high ASCVD risk with elevated LDL-C levels despite maximum statins and ; ezetimibe. In this last group, the initiation of hypolipidic antihistamine therapy should be considered for all those who have an LDL-C that has not fallen below 70 mg / dL.
"The numbers are back in the guidelines," said group member Roger S. Blumenthal, MD, director of the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, in Baltimore, Maryland. theheart.org | Medscape Cardiology. "The emphasis is on" lower is better "with proven therapies".
The AHA / ACC 2018 guideline on blood cholesterol management, approved by at least 10 other medical societies, is published today Officer of the American College of Cardiology and in Circulation concurrently with their great unveiling at the AHA sessions.
The editorial board was chaired by Scott M. Grundy, MD, PhD, University of Texas Southwestern Medical Center, Dallas, and co-chaired by Neil J. Stone, MD, Northwestern University, Chicago, Illinois.
The new document has a lot to do with the 2013 guidelines, in particular the four main categories of patients with different management needs for which statins can be considered:
Primary prevention: that is, no clinical ASCVD or diabetes but LDL-C 70 mg / dL or higher and 7.5% or higher risk at 10 years from the computer;
No clinical ASCVD but with diabetes and LDL-C of 70 mg / dL or higher;
Secondary prevention: that is, clinical ASCVD without heart failure; is
Severe primary hypercholesterolemia (LDL-C ≥190 mg / dL), often called FH.
Primary prevention: no clinical ASCVD or diabetes
From the 2013 document, "We have renewed the approach to risk assessment in primary prevention, but it still begins to calculate a 10-year risk estimate," wrote committee member Donald Lloyd-Jones, Northwestern University Feinberg School of Medicine, Chicago, told a theheart.org | Medscape Cardiology.
"This must be the starting point," said Lloyd-Jones, because the risk score influences the intensity of the management program, either through lifestyle modification or drug therapy.
"While the risk calculator has not been recalibrated, now there is a much broader guide on how the patient and the clinician should approach the risk discussion that has not received as much attention in 2013," Blumenthal said.
The 10-year risk score, he said, is in his view a "plausible hypothesis" that for most patients in the wide intermediate risk range of 7.5% to less than 20% should be a & # 39; opportunity for a shared decision-making process.
"That gray area, the intermediate range, now has a lot more emphasis on the guidelines," Blumenthal said. "An ASCVD risk score of, say, 10% or 15% does not automatically impose a statin, but it should lead to a more detailed discussion, I think this is an important step forward for these guidelines."
To aid in shared decision-making, the document specifies a series of "risk-increasing factors" that are not considered in the risk calculator and, if present, "might push us to move forward and prescribe a statin, if the patient is pleasant" said Lloyd-Jones.
Factors that improve risk include the following:
LDL-C of 160 mg / dL or higher, a C-reactive protein (high sensitivity assay) of 2.0 mg / L or higher, apolipoprotein B of 130 mg / dL or greater, or elevated lipoprotein (a);
Ankle-brachial index less than 0.9;
Comorbid conditions, such as metabolic syndrome; chronic kidney disease (CKD); chronic inflammatory disorders, such as rheumatoid arthritis, lupus or HIV; or early menopause;
Family history of premature ASCVD;
Ascendancy of South Asia; is
High-life ASCVD risk.
The paper says that for patients with borderline ASCVD risk, ie a 10-year risk of 5% to less than 7.5%, the presence of risk enhancers would favor therapy with statins with class IIb recommendation. The stimulators would favor the statins with a recommendation of class I for those at intermediate risk of 7.5% to less than 20%. For high-risk patients (ie a score of 20% or higher), high-intensity statins are favored with a class 1 recommendation.
It is important to stress that "if after this discussion, the doctor and the patient are still uncertain, or if the patient really wants a little more confirmation, we have designed specific recommendations on the use of 39; coronary artery, "said Lloyd-Jones. The imaging of the CAC would be an option primarily for intermediate-risk patients.
If the CAC score is 0, "as it will be in about 50% of these people, then we say that it is reasonable to avoid a statin," he said.
Patients with a CAC score of at least 100 Agatston units in the 75th percentile adjusted for age and sex "we say very clearly a group that will benefit from statin therapy, we not only think that they are at higher risk, but rather, their scores of calcium indicate that they have a significant load of atherosclerosis ".
If the CAC score is in the indeterminate range of 1 to 99 Agatston units, the decision could be to start a statin or repeat the scan of coronary calcium at least 2 years later. "And if it changed quickly, it would be an indicator that they might want to take a statin more into consideration," Lloyd-Jones said.
Diabetes without clinical ASCVD
The paper recommends that all patients with diabetes between the ages of 40 and 75 with an LDL-C of 70 mg / dL or higher take a statin of moderate intensity and do not need a calculated 10-year ASCVD risk assessment. A high-intensity statin, he says, should be considered for such patients with multiple risk factors.
The paper offers some flexibility, however, even in patients with diabetes, Blumenthal said: "If the patient is still not sure whether to continue statin therapy for life, as part of the discussion of risk it is certainly reasonable for them to try a period of life changes that are more intensified, and then see if they get their A1c from the range of 7% to the range of 6.5% or lower, so even with weight loss and exercise, perhaps they will improve even their lipids. "
Secondary prevention: clinical ASCVD
For this group, the document recommends maximum tolerated statin therapy and consideration of the addition of ezetimibe for those who do not reduce LDL-C by at least 50%, or less than 70 mg / dL.
Lloyd-Jones said that these patients are likely to see an additional 20% decline in LDL-C with the addition of ezetimibe. But if LDL-C remains above 70 mg / dL, then "it is reasonable to also try a PCSK9 inhibitor".
Primary severe hypercholesterolemia or FH
For patients of this category, who have an LDL-C greater than 190 mg / dL, "it is not necessary to calculate the risk at 10 years, we know that they need treatment.Then, statin therapy is most tolerated for all", Lloyd -Jones said.
If they do not show a 50% reduction in LDL-C and remain above 100 mg / dL, "then it is reasonable to first place them on ezetimibe and then consider PCSK9 inhibitors if the threshold has not yet been reached".
The guidelines document supports a "healthy lifestyle for the heart throughout the course of life" on top as a sort of foundation for its more detailed sections on risk and medical regimens.
"Even if you start with a cholesterol or blood pressure medication or both, the clinician should really stress ways to further improve their lifestyle over the next three months or six months," Blumenthal said.
As the report notes, the ACC / AHA document was also approved by the American Association of Cardiovascular Pulmonary Rehabilitation, the American Academy of Physician Assistants, the Association of Black Cardiologists, and the American College of Preventive Medicine, from the American Diabetes Association, from the American Geriatrics Society, from the American Pharmacists Association. , American Society for Preventive Cardiology, National Lipid Association and Association of Preventative Cardiovascular Nurses.
"There were 24 of us in the editorial board, and exactly zero of us had relevant relationships with industry or conflicts of interest," said Lloyd-Jones theheart.org | Medscape Cardiology.
J Am Coll Cardiol. Published online 10 November 2018. Article, Executive summary, Systematic review
Circulation. Published online 10 November 2018. Article, Executive summary, Systematic review