Evidence Gaps and Future Directionse208 Appendix 1 Author Relationships With Industry and Other Entities (Relevant)e238 Appendix 2 Reviewer Relationships With Industry and Other Entities ...(Comprehensive)e240 Preamble Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines (guidelines) with recommendations to improve cardiovascular health.In 2013, the National Heart, Lung, and Blood Institute (NHLBI) Advisory Council recommended that the NHLBI focus specifically on reviewing the highest-quality evidence and partner with other organizations to develop recommendations (P-1,P-2)....the ACC and AHA collaborated with the NHLBI and stakeholder and professional organizations to complete and publish 4 guidelines (on assessment of cardiovascular risk, lifestyle modifications to reduce cardiovascular risk, management of blood cholesterol in adults, and management of overweight and obesity in adults) to make them available to the widest possible constituency.Adherence to recommendations can be enhanced by shared decision making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated conditions and comorbidities.Methodology and Modernization The ACC/AHA Task Force on Clinical Practice Guidelines (Task Force) continuously reviews, updates, and modifies guideline methodology on the basis of published standards from organizations, including the Institute of Medicine (P-3,P-4), and on the basis of internal reevaluation.
Clinical decisions are ideally based on evidence generated from multiple randomized controlled trials (RCTs) evaluating clinical outcomes, but historically, few clinical guideline recommendations ...have been based entirely on this type of evidence.
To determine the class and level of evidence (LOE) supporting current major cardiovascular society guideline recommendations, and changes in LOE over time.
Current American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) clinical guideline documents (2008-2018), as identified on cardiovascular society websites, and immediate predecessors to these guideline documents (1999-2014), as referenced in current guideline documents.
Comprehensive guideline documents including recommendations organized by class and LOE.
The number of recommendations and the distribution of LOE (A supported by data from multiple RCTs or a single, large RCT, B supported by data from observational studies or a single RCT, and C supported by expert opinion only) were determined for each guideline document.
The proportion of guideline recommendations supported by evidence from multiple RCTs (LOE A).
Across 26 current ACC/AHA guidelines (2930 recommendations; median, 121 recommendations per guideline 25th-75th percentiles, 76-155), 248 recommendations (8.5%) were classified as LOE A, 1465 (50.0%) as LOE B, and 1217 (41.5%) as LOE C. The median proportion of LOE A recommendations was 7.9% (25th-75th percentiles, 0.9%-15.2%). Across 25 current ESC guideline documents (3399 recommendations; median, 130 recommendations per guideline 25th-75th percentiles, 111-154), 484 recommendations (14.2%) were classified as LOE A, 1053 (31.0%) as LOE B, and 1862 (54.8%) as LOE C. When comparing current guidelines with prior versions, the proportion of recommendations that were LOE A did not increase in either ACC/AHA (median, 9.0% current vs 11.7% prior) or ESC guidelines (median, 15.1% current vs 17.6% prior).
Among recommendations in major cardiovascular society guidelines, only a small percentage were supported by evidence from multiple RCTs or a single, large RCT. This pattern does not appear to have meaningfully improved from 2008 to 2018.
In 2016, the American College of Cardiology published the first expert consensus decision pathway (ECDP) on the role of non-statin therapies for low-density lipoprotein (LDL)-cholesterol lowering in ...the management of atherosclerotic cardiovascular disease (ASCVD) risk. Since the publication of that document, additional evidence and perspectives have emerged from randomized clinical trials and other sources, particularly considering the longer-term efficacy and safety of proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors in secondary prevention of ASCVD. Most notably, the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial and SPIRE-1 and -2 (Studies of PCSK9 Inhibition and the Reduction of Vascular Events), assessing evolocumab and bococizumab, respectively, have published final results of cardiovascular outcomes trials in patients with clinical ASCVD and in a smaller number of high-risk primary prevention patients. In addition, further evidence on the types of patients most likely to benefit from the use of ezetimibe in addition to statin therapy after acute coronary syndrome has been published. Based on results from these important analyses, the ECDP writing committee judged that it would be desirable to provide a focused update to help guide clinicians more clearly on decision making regarding the use of ezetimibe and PCSK9 inhibitors in patients with clinical ASCVD with or without comorbidities. In the following summary table, changes from the 2016 ECDP to the 2017 ECDP Focused Update are highlighted, and a brief rationale is provided. The content of the full document has been changed accordingly, with more extensive and detailed guidance regarding decision making provided both in the text and in the updated algorithms. Revised recommendations are provided for patients with clinical ASCVD with or without comorbidities on statin therapy for secondary prevention. The ECDP writing committee judged that these new data did not warrant changes to the decision pathways and algorithms regarding the use of ezetimibe or PCSK9 inhibitors in primary prevention patients with LDL-C <190 mg/dL with or without diabetes mellitus or patients without ASCVD and LDL-C ≥190 mg/dL not due to secondary causes. Based on feedback and further deliberation, the ECDP writing committee down-graded recommendations regarding bile acid sequestrant use, recommending bile acid sequestrants only as optional secondary agents for consideration in patients intolerant to ezetimibe. For clarification, the writing committee has also included new information on diagnostic categories of heterozygous and homozygous familial hypercholesterolemia, based on clinical criteria with and without genetic testing. Other changes to the original document were kept to a minimum to provide consistent guidance to clinicians, unless there was a compelling reason or new evidence, in which case justification is provided.
Abstract In the past 25 years, obesity and diabetes mellitus have overtaken cigarette smoking, dyslipidemia, and hypertension as risk factors for coronary heart disease. Data from a Centers for ...Disease Control and Prevention (CDC) survey of 50 states revealed that, in 2000, the prevalence of obesity among US adults was approximately 20%, a 61% increase from the 1991 prevalence rate. Currently, most adults (≥56%) are overweight, approximately 1 in 5 is obese, and 7.3% have diabetes. Overweight and obesity increase the risk for hospitalization and death from cardiovascular disease (CVD) and type 2 diabetes at all levels of risk and independently of other risk factors. In particular, abdominal obesity (assessed indirectly by measuring waist circumference) may be associated with clustering of cardiovascular and metabolic risk factors (i.e., hypertriglyceridemia, low high-density lipoprotein HDL cholesterol levels, high blood pressure, and elevated levels of fasting glucose) known as the metabolic syndrome. Patients with even minimal abnormalities in any 3 of the 5 risk factors for the metabolic syndrome are at heightened risk for CVD or diabetes. It is estimated that 47 million US adults, 25% of the population, have ≥3 metabolic syndrome components. Abdominal obesity is the most common, followed by low HDL cholesterol levels, high blood pressure, and high levels of triglycerides. The risk for disease increases over time as the number of metabolic syndrome characteristics accumulates; therefore, early intervention is warranted. Given the prevalence and potentially deadly consequences of the metabolic syndrome, it is imperative for physicians to recognize the presence of these risk factors in their patients and to familiarize themselves with the recommended treatment strategies.
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