2019 In Cardiology: Apple Heart Study Lands; Icosapent Ethyl Gets FDA Nod for New Indication; Dapagliflozin For Nondiabetics; and More

Another year in the books, and there were some important news stories in cardiology this year. 2019 carried big news for a few drug therapies, and one study early in the year gave an initial serious look at the potential of wearable technology to have an impact in cardiac care.



Presented at ACC.19, this study showed that wearable cardio tech—in this case an iWatch—is able to detect atrial fibrillation. The study included over 419,000 general population participants with Apple iWatches who were monitored using a novel tachogram-tracking algorithm that provided notifications upon detection of any pulse irregularities, with over 2,100 participants receiving notifications. The results indicated that the positive predictive value of the tachograms was 0.71 (97.5% CI, 0.69 to 0.74) and 0.84 (97.5% CI, 0.76 to 0.92) for the irregular pulse notifications. “The positive predictive value does support the ability to identify atrial fibrillation, and we think that these can provide context in the overall clinical context of everything we do,” author Mintu Turakhia, MD, of Stanford University School of Medicine, said of the results. “We think from a trial and operational standpoint this provides us with a foundation to do more digital health research.”



With its new indication, icosapent ethyl closes out 2019 with an FDA approval for the reduction of cardiovascular risk as an add-on to statin cholesterol-lowering therapy in high-risk patients, as well as an adjunct therapy for the reduction of triglyceride levels in patients with severe hypertriglyceridemia. Research looking into cardiovascular risk reduction with icosapent ethyl was presented at the American Heart Association 2018 Scientific Sessions  and formally unveiled this past January in the New England Journal of Medicine with the REDUCE-IT trial. The results of that study showed significant reductions in ischemic events and the risk for cardiovascular death in patients with elevated triglycerides who were on statin therapy. The expanded indication opens the potential market of people in the United States who qualify for use of the treatment to millions. IN a December 13, 2029 statement, FDA acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research (CDER), said that “the FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” and added that “[this] approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”



In what many would consider the headliner of the meeting, the results of the DAPA-HF trial presented at the American Heart Association 2019 Scientific Sessions (AHA 2019) suggested that the SGLT-2 inhibitor dapagliflozin was able to prevent the development of heart failure in patients with and without diabetes. The study included over 4,700 participants, most with NYHA Class II and III heart failure with reduced ejection fraction (HFrEF) and on good medical background therapy. The results indicated that dapagliflozin reduced the risk for worsening heart failure events and cardiovascular mortality while improving symptoms in patients with HFrEF. Perhaps most intriguingly, the effects of the treatment were also available to nondiabetic patients as well as diabetic patients. “The relative and absolute risk reductions in death and hospitalization were substantial, clinically important, and consistent in patients with and without type 2 diabetes,” John J.V. McMurray, BHF, of the Cardiovascular Research Centre in Glasgow, U.K., concluded in a presentation at AHA 2019.



Another big story to come out of AHA 2019 was the ISCHEMIA trial, which showed that an invasive interventional strategy featuring invasive coronary angiography followed by revascularization was no more effective than a regimen of optimal medical therapy for the prevention of cardiovascular events in patients with stable coronary artery disease. The study included more than 5,100 patients with stable coronary artery disease, preserved ejection fraction, and moderate to severe ischemia. Patients were randomized to the invasive strategy or to optimal medical therapy alone. The results showed no significant differences in the primary study endpoint of cardiovascular death, myocardial infarction, hospitalization for unstable angina, heart failure hospitalization, or resuscitation due to cardiac arrest.