What’s Hot From the American Heart Association Scientific Sessions 2021

Volume 9, Issue 3

As the American Heart Association Scientific Sessions 2021 concludes this week, let’s embark on what has become a time-honored tradition of covering meeting proceedings. In this week’s issue of Talking Therapeutics, we highlight some of the more noteworthy science, hot off the press!

Point 1: Canagliflozin Improves Heart Failure Symptoms

The CHIEF-HF trial randomized patients in a 1:1 fashion to either canagliflozin 100 mg (n=222) or matching placebo (n=226). All the patients were receiving other treatments for heart failure (HF). The trial was stopped early by the sponsor. The primary outcome, change in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at 12 weeks for canagliflozin vs placebo, difference between two groups, was 4.3 points (P=.016).

Results were similar for patients with HF with reduced ejection fraction and with preserved ejection fraction, and for patients with and without type 2 diabetes mellitus. Rates of all-cause deaths were similar between groups, and key safety data from the trial have yet to be reported.

Point 2: Empaglifozin Expands to Acute HF

The goal of the EMPULSE trial was to evaluate empagliflozin vs placebo among patients with acute decompensated heart failure. Enrolled patients were admitted to the hospital with acute heart failure regardless of ejection fraction or diabetes status. They also had to have a systolic blood pressure of at least 100 mm Hg and no symptoms of hypotension within 6 hours, no increase in intravenous (IV) diuretic dose within 6 hours, and no IV vasodilators, including nitrates, within 6 hours.

The primary analysis was assessed by a stratified win ratio, defined as a composite of death, number of heart failure events, time to first heart failure event, and change in KCCQ-TSS from baseline to 90 days. Clinical benefit occurred at a rate of 53.9% in the empagliflozin group compared with 39.7% in the placebo group (P=.0054). This difference was attributed to a reduction in deaths, heart failure events, and KCCQ-TSS scores. Rates of side effects were minimal with empagliflozin.

Point 3: Reversal for Ticagrelor Is on the Horizon

Ticagrelor is an oral P2Y12 receptor antagonist that is reversible, whereas clopidogrel and prasugrel are not. This advantage can be key in a setting where urgent hemostasis may be desired, such as in the event of an impending unexpected procedure. The REVERSE-IT trial showed that bentracimab (PB2452), a recombinant IgG1 monoclonal antibody, is safe and effective at promptly reversing the antiplatelet effect of ticagrelor among patients with major bleeding or who are undergoing an urgent surgery or procedure.

The new reversal agent has a complicated multistep loading dose procedure, which could hinder its rollout. Ultimately, the price point may derail this new therapy, as other antithrombotic reversal agents have failed to launch due to an unacceptably high price tag.