ACC Roundup: Less Aspirin to Prevent Heart Attacks, Bristol-Myers & Pfizer, Apple Watch and More
New CV Prevention Guidelines: Less Aspirin, More SGLT2s & GLP-1s
Leadership from the ACC and the American Heart Association (AHA) released updated primary prevention guidelines, dubbed the 2019 Primary Prevention in Cardiovascular Disease guidelines. Roger S. Blumenthal, professor of cardiology at Johns Hopkins and co-chair of the Guideline Committee, stated, “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. More than 80 percent 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.”
Not surprisingly, the guidelines called for a diet focused on fruit, vegetables, legumes, nuts, whole grains, and fish, low fats, fewer processed foods, and avoiding trans fats. In addition, they recommended at least 150 minutes of moderate-intensity exercise per week. More surprising, they backed off on recommending daily low-dose aspirin, because more recent evidence suggested there was greater potential for bleeding compared to the value. However, that should be determined by doctors who conduct a cardiovascular risk assessment.
For type 2 diabetes, they encouraged the use of glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide (GLP-1) receptor agonists as possible additions to lifestyle modifications and metformin for adults with type 2 diabetes and additional cardiovascular risk factors.
Bristol-Myers Squibb and Pfizer’s Eliquis
Bristol-Myers Squibb-Pfizer Alliance announced data from the Phase IV AUGUSTUS trial evaluating Eliquis (apixaban) comparing vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) and recent acute coronary syndrome (ACS) and/or undergoing percutaneous coronary intervention (PCI). The data showed that patients receiving a P2Y12 inhibitor with or without aspirin had significantly lower clinically relevant non-major (CRNM) bleeding at six months.
“Due to concern for major bleeding, there have been ongoing questions about treating non-valvular atrial fibrillation patients with acute coronary syndrome and /or undergoing percutaneous coronary intervention,” stated Ranato D. Lopes, director, Clinical Events Classification, Duke Clinical Research Institute and Principal Investigator of AUGUSTUS. “Results from this study provide additional information for physicians treating these high-risk patients.”
Novartis’s Entresto in Patients with Systolic Heart Failure
Novartis announced data from a 4-week extension of its PIONEER-HF trial. Patients received Entresto showed reductions in the HF biomarker N-terminal pro-B-type natriuretic peptide (NT-proBNP). “The evidence generated through the Entresto clinical trial program, which includes PIONEER-HF, TRANSITION-HF and PARADIGM-HF, contributes to the reimagining of heart failure treatment,” stated Marcia Kayath, Head, U.S. Medical Affairs, Novartis Pharmaceuticals. “Data from this 4-week extension of PIONEER-HF clearly support Entresto as a first-choice treatment upon systolic heart failure diagnosis or worsening of symptoms and underscore the importance of initiating Entresto in the hospital.”
Apple Watch Has Mixed Results in AF Study
Stanford University researchers kicked off the annual meeting of the ACC with a very large study of more than 400,000 patients in a trial sponsored by Apple. They presented the results of whether the Apple Watch can accurately detect heart rhythm problems. Dubbed the Apple Heart Study, the trial had 419,297 participants. The patients participating wore the Apple Watch and were sent a notification if the smartwatch detected an irregular heartbeat. They were then followed up with an ECG for verification.
The bottom line was the ECG patches confirmed atrial fibrillation in only 34 percent of the 450 patients who returned the patches. The remaining, about 66 percent, had no confirmed atrial fibrillation. This places some doubt on just how accurate the Apple Watch is at identifying atrial fibrillation, although it also appears that the patient population presented some compliance issues with the trial.
Deepak Bhatt, a cardiologist from Brigham and Women’s Hospital in Boston who was not involved in the trial, told Reuters, “The study is an important first step in figuring out how can we use these technologies in a way that’s evidence based.”
AstraZeneca’s Farxiga Valuable for Diabetes Patients with Heart Failure
AstraZeneca presented data from the Phase III DECLARE-TIMI 58 trial showing that Farxiga (dapagliflozin) decreased the relative risk of major adverse cardiovascular events (MACE) by 16 percent compared to placebo in type 2 diabetes patients who had a prior heart attack. It also reduced the relative risk of hospitalization for this patient population regardless of their ejection fraction (EF) status.
“These data build upon the existing evidence of the cardio-renal effects of Farxiga, with important new evidence on heart failure and MACE,” stated Elisabeth Bjork, Senior Vice President, Head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, for AstraZeneca. “Heart failure is one of the most common early cardiovascular complications of type 2 diabetes. Despite advances in healthcare, it remains as life-threatening and prevalent as the combined incidence of the top-four most common forms of cancer. Therefore, more needs to be done for patients.”