9 Cardiology Headlines You Missed in Q3 2026

The third quarter of 2026 was a busy one for cardiology, with several monumental approvals from the US Food and Drug Administration (FDA) and a handful of major conferences. Key trial readouts on everything from heart failure (HF) to hypertrophic cardiomyopathy (HCM) were presented at the European Society of Cardiology in Germany and the American Society for Preventive Cardiology in Arizona, while the FDA provided for great strides in the management of hypertriglyceridemia and cardiovascular risk in type 2 diabetes.

With so much major news announced over the last 3 months, the HCPLive team has collected some of the most impactful headlines to help you catch up on anything you may have missed. As we enter the fourth and final quarter of this eventful year, stay up to date with our Q3 recap:

FDA News

FDA Approves Enlicitide for LDL-C Lowering in Adults With Hypercholesterolemia

On July 16, the FDA approved enlicitide, a once-daily oral PCSK9 inhibitor, for the reduction of LDL-C in patients with hypercholesterolemia. The decision was based on 2 major phase 3 trials, CORALreef Lipids and CORALreef HeFH, which demonstrated enlicitide’s superiority to placebo in cholesterol reduction in both hypercholesterolemia and heterozygous familial hypercholesterolemia (HeFH). However, enlicitide’s cardiovascular outcomes are still uncertain – ongoing trials, namely CORALreef Outcomes, will determine its effects on morbidity and mortality.

Tirzepatide Gets FDA Approval to Cut Cardiovascular Risk in Type 2 Diabetes

On August 28, the FDA approved tirzepatide for cardiovascular disease risk in patients with type 2 diabetes, based on the SURPASS-CVOT trial. Parent company Eli Lilly positioned this trial as a higher evidentiary bar, comparing tirzepatide to dulaglutide, which holds an established cardiovascular indication. Tirzepatide ultimately displayed noninferiority for a composite of cardiovascular death, heart attack, or stroke, allowing the FDA to provide clinicians with a new option for managing these events in this population with increased risk.

FDA Approves Mavacamten for Pediatric Patients With Obstructive HCM

On September 30, just before the end of the quarter, the FDA approved mavacamten’s updated label to include pediatric patients with obstructive HCM. The decision, based on positive data from the phase 3 SCOUT-HCM trial, positions the cardiac myosin inhibitor as the first direct therapy for this underserved patient population, which represents a substantial unmet need.

Trial Readouts

SHASTA-3/4: What an 80% Triglyceride Cut Means, With Christie Ballantyne, MD

Presented at ESC 2026, the SHASTA-3 and -4 trials demonstrated plozasiran’s capacity for triglyceride reductions in patients with severe hypertriglyceridemia. Christie Ballantyne, MD, of the Baylor College of Medicine, discussed the implications of these data in an interview with HCPLive, highlighting the average 80% triglyceride reduction in the SHASTA program and the promising number needed to treat findings.

Aficamten Safe, Efficacious in nHCM, Improves Symptoms and Exercise Capacity

Another presentation from EASD 2026, this one by Ahmad Masri, MD, MS, cardiomyopathy section head at Oregon Health & Science University and director of the OHSU hypertrophic cardiomyopathy center, the ACACIA-HCM trial demonstrated aficamten’s efficacy in improving symptom burden and exercise capacity in patients with non-obstructive HCM. Additionally, investigators saw improvements in New York Heart Association functional class and NT-proBNP.

VESALIUS-CV: Evolocumab Prevents Cardiovascular Disease in High-Risk Diabetes

Presented at the American Society for Preventive Cardiology (ASPC) 2026 Congress by Marc Bonaca, MD, MPH, executive director at CPC Clinical Research and a cardiologist with Brigham and Women’s Hospital, the VESALIUS-CV trial ultimately confirmed the efficacy of evolocumab in preventing cardiovascular disease in patients with type 2 diabetes. After roughly 4.6 years of follow-up, patients ultimately saw significant reductions in coronary heart disease, ischemic stroke, myocardial infarction, or ischemia-driven arterial revascularization.

Clinician Insights

Q&A: Cutlip on the SELUTION SLR DEB’s FDA Approval for Coronary In-Stent Restenosis

On September 21, the FDA approved the SELUTION Sustained Limus Release (SLR) Drug-Eluting Balloon (DEB) for coronary in-stent restenosis. The HCPLive team spoke with Donald Cutlip, MD, to discuss the process by which the balloon achieved its approval and the gaps in care that it will fill for patients with in-stent restenosis.

Moving the Needle in Medicine: Innovation, Leadership, and the Future of Heart Failure, With Philip Adamson, MD, MSc

In this episode of Moving the Needle in Medicine, host Alex Hajduczok, MD, sits down with Philip Adamson, MD, MSc, chief medical officer of CVRx, to explore the mentors, experiences, and decisions that shaped his cardiovascular career. Adamson discusses his perspective on the transformation of HF care over the past 40 years, turning the spotlight on advancements in treatment and prediction of the disease.

Enlicitide’s FDA Approval for LDL-C Reduction and the CORALreef Outcomes Trial

In an interview with HCPLive, Ann Marie Navar, MD, PhD, associate professor of medicine in the Division of Cardiology at UT Southwestern Medical Center, discussed the FDA’s groundbreaking approval of enlicitide for LDL-C lowering in hypercholesterolemia. She discussed the results of CORALreef Lipids and CORALreef HeFH, how clinicians can circumvent similar barriers to those that injectable PCSK9 inhibitors encountered on their first rollout, and the ongoing CORALreef Outcomes trial investigating the cardiovascular impact of enlicitide.