Cardiovascular Prevention Guidelines Call for Less Aspirin, More SGLT2s, GLP-1s for Type 2 Diabetes

Billing them as a roadmap for guiding patients on everything from diet to drugs, leaders from the American College of Cardiology (ACC) and the American Heart Association (AHA) on Sunday released updated primary prevention guidelines that envision fewer people taking aspirin, but potentially more with type 2 diabetes (T2D) taking new medications that lower blood sugar.

The 2019 Primary Prevention in Cardiovascular Disease guidelines, presented at the ACC Scientific Session in New Orleans, Louisiana, build on recent joint guidelines for hypertension, cholesterol, and obesity. The document begins with 3 central recommendations for team-based care, shared decision making, and a call for clinicians to investigate social determinants of health, to eliminate barriers that keep patients from pursuing healthy lifestyles. The guidelines were simultaneously published in the Journal of the American College of Cardiology.

“The most important way to prevent cardiovascular disease, whether it’s a build-up of plaque in the arteries, heart attack, stroke, heart failure or issues with how the heart contracts and pumps blood to the rest of the body, is by adopting heart healthy habits and to do so over one’s lifetime,” Roger S. Blumenthal, MD, professor of cardiology at Johns Hopkins and co-chair of the Guideline Committee, said in a statement. “More than 80% of all cardiovascular events are preventable through lifestyle changes, yet we often fall short in terms of implementing these strategies and controlling other risk factors.”

“Nearly half of all adults in the United States now have cardiovascular disease,” said John Warner, MD, FAHA, who served as AHA president when during the 2017 joint release of the stricter hypertension guidelines. After years of steady decline, he said cardiovascular disease is rising again, and remains the leading killer of Americans. With social determinants of health affecting so much of a patient’s outcome, he said, “We have to look at the whole person.”

Unlike recommendations for how to prevent a second heart attack in a patient who has already had one, primary prevention guidelines seek to stop people from developing heart disease in the first place. The 48 specific recommendations, which start with risk factors and guidance on how early to evaluate someone’s level of cardiovascular risk, are crucial to keeping younger Americans from progressing to heart failure and end-stage renal disease, 2 costly conditions that projected to rise as obesity rates increase. The National Kidney Foundation reports that ESRD is rising 5% a year and already accounts for 7% of Medicare’s budget.

Mikhail Kosiborod, MD, FACC, clinical researcher at Saint Luke’s Mid America Heart Institute, who appeared at a separate discussion Sunday on the new ACC Expert Consensus Decision Pathway, told attendees that making prevention a priority is not simply a “moral, ethical” imperative but key to health systems’ survival. “There are other forces in play,” he said.

Lifestyle recommendations

The guidelines call for a diet focused on fruits, vegetables, legumes, nuts, whole grains, and fish. It says replacing saturated fat with dietary monounsaturated and polyunsaturated fats can be beneficial to reduce atherosclerotic cardiovascular disease (ASCVD) risk. It calls for limiting processed meats, refined carbohydrates, and sweetened beverages; in a new recommendation, the guideline calls for avoiding trans fats.

“Diet is the cornerstone of prevention,” Donna K. Arnett, PhD, MSPH, dean of the College of Public Health and professor of Epidemiology at the University of Kentucky, said during a press conference. The call for addressing social determinants of health matters here, she said, because body size assessments may vary depending on a patient’s environment, age, and socioeconomic status. Today, she said, only 1 in 3 American adults has an optimal weight.

Adults should have least 150 minutes per week of moderate-intensity exercise, such as brisk walks, or 75 minutes of high intensity exercise. For those who have been inactive, starting with 10-minute bursts throughout the day lets a person ease into more activity. Only half of Americans get enough exercise, and Arnett said this lack of activity costs the country $105 billion in medical costs.

Hypertension and cholesterol

Amit Khera, MD, MSc, FACC, FAHA, FASPC , a professor of Medicine at the University of Texas, Southwestern Medical School, presented sections of the guideline that addressed hypertension, cholesterol, and therapy options. The document recaps the 2017 ACC/AHA hypertension categories, which list stage 1 hypertension beginning at 130/80 mmHg. The guidelines contain an algorithm containing decision points for when clinicians should prescribe statins of different strengths or discuss treatment options with patients, including a recommendation that dovetails with the new Consensus Decision Pathway and calls for coronary artery calcium (CAC) testing in some circumstances when risk levels are unclear.

Type 2 diabetes

Today, Khera said, it is estimated that 12% of the US adult population has diabetes. “It’s not about blood sugar alone,” referring to the old paradigm of just managing glycated hemoglobin (A1C) levels. Preventing cardiovascular disease in T2D patients requires a comprehensive prevention strategy, Khera said; these patients need a tailored nutrition plan, physical activity, and the right medication for primary prevention.

“There have been new developments,” Khera said, referring to a wave of cardiovascular outcomes trials (CVOTs) for 2 new drug classes—the sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide (GLP-1) receptor agonists—as well collaboration between ACC and the American Diabetes Association to agree on when to prescribe them for patients with T2D and ASCVD.

Today’s recommendation reads, “For adults with T2DM and additional ASCVD risk factors who require glucose-lowering therapy despite initial lifestyle modifications and metformin, it may be reasonable to initiate a sodium-glucose cotransporter 2 inhibitor or a glucagon-like peptide-1 receptor agonist to improve glycemic control and reduce CVD risk.”

While Khera emphasized that the evidence level for the recommendation is Level 2b, or “weak,” the lowest available, the guideline does represent a shift by cardiologists to using T2D therapies in primary prevention, based on evidence that has emerged from the CVOTs ordered by FDA in 2008. The guideline promises to be significant with a wave of trials expected involving SGLT2 inhibitors in heart failure and renal disease, as manufacturers will likely cite it when asking payers for coverage consideration if they receive expanded indications.

AstraZeneca, maker of the SGLT2 inhibitor dapagliflozin (Farxiga), praised the update in a statement and referenced results from its DECLARE cardiovascular outcomes trial presented in November. "The guideline references the heart failure results from the DECLARE trial in patients with CV risk factors. DECLARE is the first SGLT2i cardiovascular outcomes trial to include hospitalization for heart failure as a primary endpoint and studied nearly 60% of patients with multiple CV risk factors. Heart failure is the number one cardiac complication in T2D, and those with T2D have a 2-to-5 time greater risk of heart failure along with an increased risk of other cardiovascular complications like heart attack or stroke."

Asked by The American Journal of Managed Care® if the primary prevention guidelines would follow the Expert Consensus Pathway and single out a preferred therapy in each class, Khera said the new guidelines are recommending the classes in their entirety.

Backing off on aspirin

The ACC/AHA guideline makes clear that aspirin remains life-saving when prescribed following an event such as a heart attack or placement of a stent. But for others, recent evidence shows the risk-benefit analysis tipping away from widespread use of low-dose aspirin due to the potential for bleeding. Doctors should not be prescribing it without a cardiovascular risk assessment, the recommendations say.

Low-dose aspirin (75-100 mg orally daily) might be considered for the primary prevention of ASCVD among those adults 40 to 70 years of age who are at higher risk of ASCVD risk, but not at increased bleeding risk. Low-dose aspirin on a routine basis should not be given to prevent ASCVD among adults once they reach age 70, and it should not be given to any adult with increased bleeding risk.

Bayer released a statement emphasizing aspirin's role in secondary prevention. "For those who have already experienced a heart attack, stroke or other cardiovascular event, discontinuing an aspirin regimen without a doctor’s guidance could increase the risk of another heart attack by 63% and an ischemic stroke by 40%," the statement read in part. "The guidelines do not change the role of aspirin during a suspected heart attack as directed by a doctor."

Reference

Arnett DK, Blumenthal RS, Albert MA, et al, for the Writing Committee. 2019 ACC/AHA Guideline on the primary prevention of cardiovascular disease: Executive Summary. [published March 17, 2019]. J Am Coll Cardiol. doi: https://doi.org/10.1016/j.jacc.2019.03.009.