Data for Therapies to Treat Cholesterol, PAH Highlight ACC Scientific Sessions

Clinical trials for therapies that fight cholesterol and boost exercise capacity for those with pulmonary arterial hypertension (PAH) are among the highlights at this weekend’s 72nd American College of Cardiology (ACC) Scientific Session, which start Saturday in New Orleans, Louisiana and run through Monday.

The meeting, officially ACC.23 Together with World Congress of Cardiology, returns to the Ernest N. Morial Convention Center for the first time since 2019. Organizers expect attendance close to prepandemic levels, which were above 20,000. The meeting is partly virtual; 80 of the more than 300 sessions will be streamed live, and all will be available on demand later.

Meeting Chair Douglas Drachman, MD, FACC, of Massachusetts General Hospital, said during a preview call that the meeting will regain its international flavor, with the more than 4000 accepted abstracts coming from 84 countries. Meeting Vice Chair Katie Berlacher, MD, MS, FACC, of the University of Pittsburgh, said that 146 abstracts were submitted for the late-breaking and featured clinical science sessions—50% from the United States, and 50% international. Of these, 43 were accepted.

Value-based care. Although drug trials dominate the late-breaking and featured clinical science sessions, they aren’t the whole story. For the first time in years, a study involving value-based insurance design will be featured Sunday, when Braden Manns, MD, MSc, of the University of Calgary presents results from ACCESS, a randomized trial that studied the effect of eliminating copayments for therapy for chronic conditions among low-income seniors.

The ACC Scientific Sessions are always tech-friendly and 2023 is no exception: top sessions will feature results involving a cardiac device measuring greenhouse emissions, the use of artificial intelligence (AI) to evaluate risk for coronary artery disease, and the use of electronic nudges to improve uptake of flu shots.

Cholesterol, PAH, and more. Saturday’s first late-breaking session will feature “Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes.” Esperion has previously announced topline results for this adenosine triphosphate-citrate lyase inhibitor, sold as Nexletol.

Steven Nissen, MD, chief academic officer of the Heart, Vascular and Thoracic Institute at Cleveland Clinic, will present results for the trial, which will show that the lipid-lowering therapy met its primary end point for reducing major adverse cardiovascular events (MACE-4).

Another highlight will come near the meeting’s end on Monday, when with results for the phase 3 STELLAR trial, “A Study of Sotatercept in Combination With Background Therapy For the Treatment of Pulmonary Arterial Hypertension.” Merck has previously announced that the study met its primary efficacy outcome measure by demonstrating a statistically significant and clinically meaningful improvement in a 6-minute walk distance test after 24 weeks. Marius M. Hoeper, MD, professor at Hannover Medical School in Germany, will present the results.

Berlacher highlighted several other studies in the ACC preview call, including HALO, a phase 2 study evaluating baxdrostat, one of a class of investigational therapies for resistant hypertension. CinCor Pharma announced in December that HALO had not met its primary endpoint in intention to treat, but it showed large absolute reductions in systolic blood pressure and important reductions in some subgroups; an earlier study, BrigHtn, showed dose-related reductions in blood pressure.

Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart and the Dr Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine Mount Sinai Health System, who will be presenting HALO, said the study population was “lower down the risk ladder” than BrigHtn.

Bhatt’s other appearances at ACC include a presentation of results for ENTRIGUE, a phase 2 study of pegozafermin in severe hypertriglyceridemia. Asked what he’s looking forward to at ACC, he listed the COAPT Trial, which will show 5-year data on the MitraClip; studies on complete revascularization that show, “it is better to do it earlier versus later,” and the FREEDOM COVID trial, being presented by his Mount Sinai colleague Valentin Fuster, MD, which examines whether there is a role for anticoagulation in patients hospitalized with COVID.

Finally, Bhatt mentioned a meta-analysis that will examine data form the PROMINENT trial, the REDUCE-IT trial that he led involving icosapent ethyl, and the STRENGTH trial, which is “pulling the data to see what impact different biomarkers have on residual risk.”

Special topics. Each year, ACC hosts a half-day “intensive” on an emerging topic, and this year’s session is critical care cardiology. There are also late-breaking presentations and sessions involving cardio-oncology, data on how reproductive technologies can raise the risk of preeclampsia, and timely results on the question of how quickly elite athletes should return to training if they have a genetic variant that poses a risk of sudden cardiac death.

Issues of health equity are scheduled across the conference, highlighted by the address set for Sunday morning by Clyde W. Yancy, MD, chief of cardiology and vice dean for Diversity and Inclusion at Northwestern University Feinberg School of Medicine. Yancy will deliver the Kanu and Docey Chatterlee Keynote: Heart Failure Guidelines: “What is Needed in 2023 and Beyond to Ensure Equitable Care for All Patients?”