Gaps in the Cardiovascular Lipid and Risk Assessment Guidelines

September 7 - 8 , 2014
Bethesda, MD


On September 8 - 9, 2014, the National Heart, Lung, and Blood Institute (NHLBI) convened a group of experts in the areas of cardiovascular risk assessment, treatment of blood cholesterol to reduce cardiovascular risk, and implementation and dissemination.  The goal was to examine the gaps in scientific knowledge identified by the expert panels initially convened by NHLBI and later by the American College of Cardiology and American Heart Association (ACC/AHA) for the recent update to the cardiovascular guidelines and by the scientific community after the release of the guidelines.  During the workshop, the process and history of the relevant cardiovascular guidelines was reviewed as was the current process used by NHLBI for determining strategic priorities.  Finally, workshop attendees reviewed the gaps in each of the three areas (treatment of blood cholesterol, cardiovascular risk assessment, and implementation and dissemination of the cardiovascular guidelines), and identified those that were of the highest priority for future research studies.


Treatment of Blood Cholesterol to Reduce Cardiovascular Disease

A consensus was reached on gaps that had a high priority for future randomized controlled trials.  These were:

  • In individuals over the age of 75 with no history of clinical cardiovascular disease, does provision of statin medication reduce subsequent cardiovascular disease?
  • In individuals with a low short term risk but a high lifetime risk of cardiovascular disease, does treatment with statin therapy compared to an intensive lifestyle intervention result in improved outcomes?
  • In individuals with moderate to high risk of cardiovascular disease, does a strategy of treating blood cholesterol to a specific value result in better clinical outcomes than the current strategy of treatment with a standard base dose of statin medication?

Several areas with incomplete evidence that could be best answered with an observational study design were also identified.  The highest priority questions and tasks were:

  • What is the risk/benefit of the use of statin therapy to prevent cardiovascular disease in individuals from different race and ethnicity groups?
  • Development of equations that account for risk and benefit at an individual level to provide a personalized risk/benefit ratio of lipid-lowering therapy.

Cardiovascular Risk Assessment

A consensus was reached on gaps that had a high priority for future randomized controlled trials.  These were:

  • In patients without a history of clinical cardiovascular disease, which strategy is the most effective at reducing subsequent cardiovascular disease:  1. pre-clinical disease screening (such as coronary artery calcium or similar detection strategy); 2. risk assessment screening and treatment; or 3. treatment of all patients over a certain age regardless of risk?
  • Does a strategy of treatment of individual risk factors (such as lipid levels, smoking, diabetes or blood pressure) to optimal levels result in fewer clinical events compared to the current strategy of basing use of statin medication on a global risk equation?
  • Developing and testing various strategies to communicate risk to patients to determine effectiveness on clinical outcomes, including adherence to lifestyle and drug therapy and risk factor levels.

The committee also agreed that several research gaps could be best addressed through the use of other study designs.  These high priority areas included:

  • Examining the impact on risk estimation when either currently available and new biomarkers or non-invasive imaging is included in the risk equation; determining if the inclusion of socio-economic characteristics improves risk prediction; and determining the impact of time-varying medication use and changing risk factor level on risk estimates.

Implementation of Cardiovascular Guidelines

The final area of discussion was on the planned report regarding the implementation of cardiovascular guidelines.  The original purpose of this report was to review and evaluate potential strategies to assist in the widespread implementation of the newly released guidelines.  While this report has not yet been completed, representatives from the group did discuss the process and potential knowledge gaps.  Important areas of potential future research include:

  • Examining the role of the sociocultural environment of patients (including race/ethnicity, gender, and health literacy) on successful implementation of cardiovascular guidelines.
  • Enhancing our understanding of best practices for the implementation of guidelines.   This could be accomplished through the development of a “Best Practices” consortium of groups with a successful track record of implementation as well as other stakeholders (including care networks, payers, governmental agencies, and others).   An evaluation of ongoing and future efforts to implement the recently released guidelines is also needed.
  • Developing interventions to improve long-term adherence to medication and lifestyle behaviors in patients.


Jennifer G. Robinson, MD, MPH
Professor, Department of Epidemiology
Director, Prevention Intervention Center
College of Public Health
University of Iowa

Alain Bertoni, MD, MPH
Professor and Chair
Department of Epidemiology and Prevention
Division of Public Health Sciences
Wake Forest University Health Sciences


Matthew Allison, MD, MPH
Associate Professor
Department of Family and Preventive Medicine
University of California, San Diego

Crystal Wiley Cené, MD, MPH
Assistant Professor
Division of General Internal Medicine
University of North Carolina, Chapel Hill

David C. Goff, Jr., MD, PhD
Colorado School of Public Health

Erin D. Michos, MD, MHS, FACC
Assistant Professor of Medicine
Johns Hopkins Ciccarone Center for the Prevention of Heart Disease
Division of Cardiology
Johns Hopkins School of Medicine

Christie Mitchell Ballantyne, MD
Professor of Medicine and Pediatrics
Chief, Section of Cardiology
Baylor College of Medicine

Wiley Chan, MD
Director, Guidelines & Evidence-Based Medicine
Physician, Internal Medicine
NW Permanente

Donald Lloyd-Jones, MD, ScM
Senior Associate Dean for Clinical and Translational Research
Chair, Department of Preventive Medicine
Northwestern University

Patrick J. O’Connor, MD, MA, MPH
Senior Clinical Investigator
Assistant Medical Director
Health Partners Research Foundation

Last Updated: March 2015