CHICAGO – The world of cholesterol management and prevention of coronary disease has come a long way since 2013 when a major exercise guidance document called for radical shifts in low-density lipoprotein (LDL-C) lowering, praise and blame strategies became confusion.
The most recent incarnation of this document, presented here at the American Heart Association (AHA) Scientific Sessions 2018, retains the essence of the original and focuses again on cherished principles that took a back seat in 2013.
Importantly, the AHA / American College of Cardiology (ACC) 2018 Guideline on the treatment of cholesterol in blood provides specific guidance on the use of proprotein convertase subtilisin / kexin-9 inhibitors (PCSK9), namely, evolocumab (Repatha, Amgen) and alirocumab (PraluentSanofi / Regeneron).
The 2018 Directive contains one of the most contentious changes to the 2013 document, a scoring system for the 10-year risk of atherosclerotic cardiovascular disease (ASCVD), but has modified it to include more population data than before. Basically, however, it seems to limit the impact of the ASCVD risk calculator as a trigger for statin therapy.
The eligibility gap is largely filled by the limited restoration of LDL-C treatment goals, especially in higher-risk groups, and a major investment in physician-patient communication for shared decision-making, especially for patients with primary intermediate-risk prevention.
In the latter group, the values of coronary artery calcium carcinoma (CAC) are retained for limited use as a potential "binding breaker" in the Statin-Or-Not decision-making process.
The guideline recommends PCSK9 inhibitors, whose post-2013 randomized trials were mainly targeted for patients with familial hypercholesterolemia (FH) and for patients at very high ASCVD risk with elevated LDL-C levels despite maximal statins and ezetimibe. In this latter group, the onset of nonstatin lipid lowering therapy should be considered for all individuals with LDL-C who have not dropped below 70 mg / dl.
"The numbers are back in the guidelines," said Roger S. Blumenthal, director of the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, from Baltimore, Maryland theheart.org | Medscape cardiology, "For proven therapies, the focus is on 'less is better'."
The AHA / ACC 2018 Guideline on Blood Cholesterol, which is supported by at least ten other medical societies, is now published in the EU Journal of the American College of Cardiology and in traffic coincide with their great revelation at the AHA sessions.
The writing committee was chaired by Scott M. Grundy (MD, PhD) at Southwestern Medical Center, University of Texas, Dallas, and co-chaired by Neil J. Stone (MD, Northwestern University, Chicago, Illinois).
The new document contributes much to the 2013 Guidelines, in particular the four main categories of patients with different administrative needs, for whom statins can be considered:
Primary prevention: ie no clinical ASCVD or diabetes, but LDL-C 70 mg / dl or more and 7.5% or higher 10-year risk by the calculator;
No clinical ASCVD but with diabetes and LDL-C of 70 mg / dL or more;
Secondary prevention: ie clinical ASCVD without heart failure; and
Severe primary hypercholesterolemia (LDL-C ≥ 190 mg / dL), commonly referred to as FH.
Primary prevention: No clinical ASCVD or diabetes
Since the 2013 document: "We have revised our approach to risk assessment in primary prevention, but it is still starting to calculate a 10-year risk assessment," writes Donald Lloyd-Jones, member of the committee committee of Northwestern University's Feinberg School of Medicine, Chicago, said theheart.org | Medscape cardiology,
"This must be a starting point," said Lloyd-Jones, because the risk score influences the intensity of the management program, whether through lifestyle changes or drug therapy.
"Although the risk calculator has not been recalibrated, there are now much better guidelines on how the patient and clinician should approach the risk discussion that did not receive as much attention in 2013," Blumenthal said.
He believes that the 10-year risk score is an "educated guess" that should be an opportunity for collective decision-making for most broad-risk patients ranging from 7.5% to less than 20%.
"This gray area, the intermediate area, has much more force in the directive," Blumenthal said. "An ASCVD risk score of, say, 10% or 15% does not automatically require a statin, but it should lead to a more in-depth discussion, and I think that's a big step forward for these guidelines."
To help with joint decision making, the document cites a number of "risk assessment factors" that are not included in the risk calculator and, if available, "could urge us to prescribe a statin if the patient does so is enjoyable", said Lloyd-Jones.
The risk enhancers include the following:
LDL-C of 160 mg / dl or more, a C-reactive protein (high-sensitivity assay) of 2.0 mg / l or more, apolipoprotein B of 130 mg / dl or more or an increased lipoprotein (a);
Ankle brachial index below 0.9;
Comorbid conditions such as metabolic syndrome; chronic kidney disease (CKD); chronic inflammatory diseases such as rheumatoid arthritis, lupus or HIV; or premature menopause;
Family history of premature ASCVD;
South Asian descent; and
Increased lifespan of the ASCVD risk.
The document states that in patients with borderline ASCVD risk, ie a 10-year risk of 5% to less than 7.5%, the presence of risk enhancers would favor statin therapy with the Class IIb recommendation. The enhancers would prefer statins with a Class I recommendation for persons at medium risk of 7.5% to less than 20%. In high-risk patients (ie, a score of 20% or higher), high-intensity statins are preferred with a Class 1 recommendation.
"If, after this discussion, the doctor and the patient are still unsure, or if the patient really wishes something more confirmation, we have developed specific recommendations for the use of calcium screening of the coronary arteries," said Lloyd-Jones. CAC imaging would be an option, especially for middle-risk patients.
If the CAC value is 0, "as will be the case in about 50% of these people, we say it makes sense 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 quite clearly, a group that will benefit from statin therapy, and we not only believe that they are at greater risk but actually your calcium levels indicate that they have a significant burden of arteriosclerosis. "
If the CAC score is in the indeterminate range of 1 to 99 Agatston units, the decision may be to initiate a statin or repeat the coronary calcium scan at least two years later. "And if it's changed quickly, that would be an indicator that you want to take a statin more into consideration," said Lloyd-Jones.
Diabetes without clinical ASCVD
The document recommends that all patients with diabetes aged 40 to 75 years with an LDL-C level of 70 mg / dL or more take a moderate-intensity statin and do not require a calculated 10-year ASCVD risk assessment. A high-intensity statin should be considered for those patients with multiple risk factors.
The document offers some flexibility, but even in patients with diabetes, Blumenthal said: "If the patient is still not sure if he should take a lifelong statin therapy, it makes sense in the risk discussion to try a lifestyle changes, who are more intense, and then see if they bring their A1c from 7% to 6.5% or less, then they can also improve their lipids through weight loss and exercise. "
Secondary prevention: Clinical ASCVD
For this group, the document recommends maximum tolerated statin therapy, and consideration of additional ezetimibe for those who do not reduce LDL-C by at least 50% or to less than 70 mg / dL.
Lloyd-Jones said that in these patients, on average, an additional 20% decrease in LDL-C is expected with the addition of ezetimibe. However, if LDL-C stays more than 70 mg / dL, it makes sense to use an additional PCSK9 inhibitor.
Severe primary hypercholesterolemia or FH
For patients in this category who have LDL-C greater than 190 mg / dL, "you do not have to calculate their 10-year risk, we know they need treatment, so, maximum tolerated statin therapy for all," Lloyd-Jones said.
If they do not show a 50% reduction in LDL-C and it stays above 100 mg / dL, "it makes sense to put them first on ezetimibe and then consider PCSK9 inhibitors if the threshold is not reached . "
The document of the guidelines advocates a "healthy lifestyle" in the upper life as a kind of basis for its more detailed sections on risks and medical interventions.
"Even if you start with a medicine for cholesterol or blood pressure or both, the clinician should really stress how to improve his lifestyle over the next three or six months," said Blumenthal.
The report also found that the ACC / AHA document was also approved by the American Association for Cardiovascular Pulmonary Rehabilitation, the American Academy of Physician Assistants, the Association of Black Cardiologists, the American College of Preventive Medicine, the American Diabetes Association, the American Geriatrics Society and Approved by the American Pharmacists Association, American Society for Preventive Cardiology, National Lipid Association and Preventive Cardiovascular Nurses Association.
"There were 24 of us on the writing committee and exactly zero of us had relevant relationships with industry or conflicts of interest," said Lloyd-Jones theheart.org | Medscape cardiology.
J Coll Coll Cardiol. Published online on November 10, 2018. Article, Executive Summary, Systematic Review
traffic, Published online on November 10, 2018. Article, Executive Summary, Systematic Review