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CVD prevention hallmark of precision medicine
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ANAHEIM, Calif. — Focusing on CVD prevention is critical in the era of precision medicine, according to a presentation at the American Heart Association Scientific Sessions.
Much of precision medicine to date has focused on targeting treatments based on more information specific to an individual. Precision approaches can be applied to prevention, but prevention differs in important ways from treatment in that prevention what is done for patients in the clinical setting when they do not have signs or symptoms of a disease to prevent future pain and suffering from the disease. These messages were delivered by Kirsten Bibbins-Domingo, PhD, MD, MAS, Lee Goldman, MD Endowed Chair in Medicine, professor and chair of epidemiology and biostatistics and vice dean for population health and health equity at University of California, San Francisco and immediate past chair of the U.S. Preventive Services Task Force at the outset of her Ancel Keys Memorial Lecture.
“The stakes are high when it comes to prevention because the patient in front of us is generally well when we’re making this recommendation and not worried about a specific symptom,” she said. “That’s the fundamental challenge for us as we evaluate evidence and as we think about what standards of evidence really inform what we recommend to our patients who feel well today in order to prevent suffering in the future.”
Precision medicine focuses on the individual patient when identifying strategies for prevention and treatment. New tools such as large amounts of data from multiple dimensions and advances in computing allows quicker analysis to determine the best therapeutic options for a particular patient.
CVD prevention is ahead of other conditions when tailoring a prevention strategy for a patient, according to Bibbins-Domingo, because of the longstanding focus on CVD prevention of tailoring approaches to the underlying CVD risk of the patient.
“This [difference] was made clear to me as the chair of the task force and serving on the task force for 7 years — how ingrained our focus on tailoring CVD prevention to underlying patient risk is and how this differs from preventive strategies for other diseases,” Bibbins-Domingo said.
Tailoring CVD prevention to underlying risk has long been the paradigm, grounded in observations from the Framingham study launched in 1960, when the concept of risk factors and how they come together was first described in a comprehensive manner. The observations in Framingham led to the development of the 10-year risk equation in 1998 and Third Report of the Adult Treatment Panel (ATP III) cholesterol guidelines based on risk in 2001. Refinements have been made in between, including new risk factors, lifetime risk, multiethnic populations and contemporary event rates and the current Pooled Cohort Risk Equations to define CVD risk of an individual patient.
Although risk may be refined through precision approaches, novel measures and biomarkers, risk calculators often leave out portions of the population such as older adults, young adults and those of low socioeconomic status, Bibbins-Domingo said.
More information is needed about harms when analyzing the increasing data available to clinicians, because harms are an essential element for determining the likelihood that a given patient will experience overall benefit from a particular preventive strategy. The harms of prevention are important to understand, but challenging to define since they are less common than benefits, knowledge about harms can only be known over time and they are heterogenous, according to the presentation.
“The patient is evaluating benefits and risks in terms of their own personal values, so not only do we have to understand biologically their likelihood of a particular benefit or risk, but also how that patient might value that particular benefit or risk,” Bibbins-Domingo said.
In a study published in Circulation in 2017, researchers found that there is net benefit in the cost analysis of treating patients with statins based on ATP III, American Heart Association and universal guidelines, even when the potential harms of statins are assumed.
“This says that statin guidelines are pretty robust even to very high estimates of harms, including those that we haven’t yet anticipated,” Bibbins-Domingo said.
Although statins are beneficial for primary prevention, patients who are bothered by taking a daily pill may have this benefit offset.
“As we increase the number of people taking statins for primary prevention, we include more and more low-risk people — most of whom will not derive the CVD benefit from their daily statin,” Bibbins-Domingo said. “For some of these people, taking a daily pill is annoying and that ‘bother factor’ can itself impact their quality of life. That means that as we broaden statin use, some people have more daily annoyance because of the daily medication without the CVD prevention benefit. Ideally, more real-time data about harms, more real-time data about the absolute likelihood of benefit and tools to facilitate more real-time patient center decision-making can allow doctors and patients to tailor these discussions further for individual patients.”
Advancements in computing, measurements and data integration can potentially be harnessed to improve CVD prevention. These advancements may lead to new therapies and targets, improved understanding of risk and of less common conditions, comprehensive assessment of treatment harms and an improved assessment of individual harms to aid in decision-making.
Additional measurements and more real-time assessments in the clinical setting may allow clinicians to shift away from baseline risk to tailor therapy to absolute risk reduction, allowing us to move to “benefit-targeted prevention” rather than “risk-targeted prevention,” according to the presentation. Lifestyle interventions can also benefit from the data and technological precision approaches.
Bibbins-Domingo also described some of the tensions in more individually targeted approaches to prevention and other effective strategies that have a different approach. For example, although BP control had improved in the U.S., it has since stalled and now dropped below 50%. Some institutions, particularly Kaiser Permanente in Oakland, have achieved more than 80% BP control using an approach to decrease variability in clinical practice rather than focus on individual patient variability.
“Their approach reduces the individual decision-making made by each doctor about what medication and when they were going to use it,” Bibbins-Domingo said. “By saying, ‘This is our algorithm. This is the next step, and allowing all members of the health care team to engage in following this plan, more patients have achieved control of their blood pressure.”
Precision approaches in measurement and data integration will still be critical for achieving optimal BP control for everyone, as clinicians know that improved BP measurements and integrating out-of-office measurements into clinical decision-making have also been shown to improve control, Bibbins-Domingo said. These approaches, particularly integrating individual data on BPs from non-health care setting, may be important for reaching more hard-to-reach patients.
In a study published in the Archives of Internal Medicine in 2011, patients had an 8.8-percentage-point improvement in the percentage of controlled hypertension in patients assigned BP measurement by their barbers who also delivered personalized peer health messaging. More improvement was not seen because the measurements that were then given to the physicians were not acted upon, according to the presentation.
Discussion of how to integrate precision approaches into the lexicon and frameworks for evidence-based medicine is critically important, Bibbins-Domingo said.
“The challenge to me when I think about precision medicine is that the name itself implies certainty,” Bibbins-Domingo said. “We are embarking upon a set of studies that are inherently uncertain, and the question is how we evaluate and integrate the best of these approaches to make the best decisions for our patients.”
Developing frameworks for integrating precision medicine into evidence-based practice in CVD prevention will be challenging, but will be possible in the field of CVD prevention. those who have been engaged in the scholarship of CVD prevention have been known for being outstanding methodologists for having a track record for commitment to high standards for evidence, for a history of tailoring approaches in response to new evidence and for openness for innovation and input from a diverse community of clinicians and scientists who focus on prevention.
“I hope you will engage with me in these discussions about precision medicine and prevention because I think there is an interesting and important road ahead,” Bibbins-Domingo said. – by Darlene Dobkowski
References:
Bibbins-Domingo K. Ancel Keys Memorial Lecture: Lifestyle and Medical Therapy for CVD Prevention. Presented at: American Heart Association Scientific Sessions; Nov. 11-15, 2017; Anaheim, Calif.
Heller DJ, et al. Circulation. 2017;doi:10.1161/CIRCULATIONAHA.117.027067.
Victor RG, et al. Arch Intern Med. 2011;doi:10.1001/archinternmed.2010.390.
Disclosure: Bibbins-Domingo reports no relevant financial disclosures.