Studies With Potential to Change the Science of Heart Failure Management

These 4 studies were pegged as “ones to watch” during the American College of Cardiology (ACC) annual briefing on results for consumers. They will be presented in the opening session of late-breaking clinical trial results on day 1 of ACC.21.

Results from several late-breaking clinical trials will be presented in the opening session on day 1 of ACC.21, the American College of Cardiology’s (ACC) 70th Scientific Session to be held May 15-17, in a joint session with Journal of the American College of Cardiology.

In the ACC’s annual consumer briefing, ACC.21 Vice-Chair Douglas Drachman, MD, the Corrigan Minehan Heart Center Director of Education and the Teresa G. and Ferdinand F. Martignetti Endowed Chair for Cardiovascular Medicine at the Massachusetts General Hospital, outlined 4 trials to watch.

PARADISE-MI

In this trial, primary author Mark Pfeffer, MD, PhD—his SAVE trial showed the promise of angiotensin-converting enzyme (ACE) inhibitors for heart failure with reduced ejection fraction (HFrEF)—and his team investigated the use of angiotensin receptor neprilysin inhibitors (ARNIs) vs ACE inhibitors after myocardial infarction (MI) in persons with HFrEF below 40%. Specifically, sacubitril valsartan vs ramipril, respectively. The primary outcome is cardiovascular death, heart failure, hospitalization, or development of symptomatic heart failure.

ADAPTABLE

This trial looked at the safety and long-term effectiveness of platelet-inhibiting aspirin in 2 doses, 81 mg compared with 325 mg, among patients with a history of cardiovascular disease (CVD). The authors sought to answer what is the optimal dose of aspirin when it is used as a secondary preventive measure, especially in light of the ongoing debate on aspirin’s benefits and risks in this patient population. Primary outcomes include all-cause death, hospitalization due to MI, hospitalization due to stroke, and hospitalization for bleeding requiring transfusion.

Drachman noted that this trial “may serve as a template for future pragmatic clinical trial design in the real world.”

LAAOS III

Does occlusion of the left atrial appendage during cardiac surgery for another reason work at reducing occurrence of stroke in patients with atrial fibrillation (AFib) on systemic anticoagulants, and do these patients have a lower long-term risk of stroke or systemic embolism? Investigators are looking into this outcome among patients with valvular heart disease, “who actually comprise over 50% of patients who undergo cardiac surgery who also have atrial fibrillation,” Drachman stated during the call. “This could really help to fill a gap in our current contemporary knowledge.

ATLANTIS

After transcatheter aortic valve replacement (TAV), what is the optimal antithrombotic therapy: systemic anticoagulation or antiplatelet therapies, or a combination of the two? For anticoagulants, is warfarin or a newer non–vitamin K oral anticoagulant preferred, such as a novel oral anticoagulant or direct oral anticoagulant?

To answer these questions, investigators looked at standard-of-care treatment vs twice-daily apixaban therapy, either 2.5 mg or 5 mg, following TAV. The primary outcome is all-cause death, transient ischemic attack or stroke, MI, valve thrombosis, pulmonary embolism, deep venous thrombosis, systemic embolism, or major bleeding.