ARNI Therapy in the Hot Seat at Another Virtual ACC

Is angiotensin receptor-neprilysin inhibition (ARNI) doomed as a therapy for heart attack survivors with left ventricular dysfunction? Or could there be some redeeming data to suggest otherwise?

The answer is expected from the PARADISE-MI study presentation to be held during the opening late-breaking trial session at this year’s virtual American College of Cardiology (ACC) meeting.

PARADISE-MI is the first head-to-head comparison of ARNI versus angiotensin-converting enzyme (ACE) inhibitor therapy after myocardial infarction (MI) in patients who have reduced left ventricular ejection fraction. Investigators randomized more than 5,600 patients to sacubitril/valsartan (Entresto) or ramipril, their primary endpoint being cardiovascular death, heart failure hospitalization, or development of symptomatic heart failure.

With this late-breaker, Mark Pfeffer, MD, PhD, of Brigham and Women’s Hospital and Harvard Medical School in Boston, returns to the stage with information on a newer drug nearly 30 years after his SAVE study that made ACE inhibitors the mainstay of therapy for these MI patients.

“Of interest, Novartis recently released the topline result that while numerical trends consistently favored ARNI over [the] ACE inhibitor, the study failed to meet the primary endpoint for efficacy, superiority, but we are all eagerly awaiting the detailed report at ACC ’21 to learn how these findings will help us to direct future care for patients with MI and left ventricular dysfunction,” said conference vice chair Douglas Drachman, MD, of Massachusetts General Hospital in Boston, during an ACC press briefing.

The ACC meeting will take place over 3 days starting Saturday.

Originally scheduled for March in Atlanta, it had been delayed with hopes of keeping an in-person attendance option open amid uncertainty surrounding COVID-19. In February, however, ACC leaders decided to make it fully virtual — similar to last year’s conference at the beginning of the COVID-19 pandemic.

“Certainly cardiovascular concerns during COVID-19 remain an important topic as we continue to navigate the pandemic and vaccinate the global patient population [that] had more than 140 million cases, 3 million deaths around the world,” said ACC conference chair Pamela Morris, MD, of the Medical University of South Carolina in Charleston, during the briefing.

Morris highlighted Saturday’s two COVID-19 intensive sessions that will update participants on progress and lessons learned from the pandemic, including a keynote speech on health equity in cardiology.

COVID-19 will also rear its head in the scientific program, notably in the DARE-19 study of dapagliflozin (Farxiga) versus placebo among SARS-CoV-2-infected patients with respiratory failure.

Other studies to take the spotlight at ACC include:

  • ADAPTABLE, which compared aspirin 81 mg versus 325 mg for secondary prevention in people with known cardiovascular disease. Its “very novel pragmatic trial design” could “serve as a template” for future studies, according to Drachman.
  • The FLOWER-MI trial of fractional flow reserve versus angiography to guide complete revascularization in ST-segment elevation MI
  • RADIANCE-HTN TRIO data on ultrasound-based renal denervation in people who are resistant to three antihypertensive medications
  • Secondary analysis of the GALACTIC-HF trial probing the impact of ejection fraction on the benefits of omecamtiv mecarbil in heart failure
  • A comparison of moderate versus mild cooling in therapeutic hypothermia for out-of-hospital cardiac arrest patients in the CAPITAL CHILL study

In total, the ACC conference will feature 25 late-breaking clinical trials over five sessions and 17 featured clinical research presentations in three sessions, along with other oral and poster abstracts.

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    Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow








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