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Our March 2023 cardiology month in review features top headlines from ACC.23, an approval for children with HoFH, and a feature celebrating the 10-year anniversary of the first SGLT2 inhibitor approval.
The month of March 2023 was a memorable one for the cardiology community.
Playing host to the American College of Cardiology’s (ACC) 2023 Annual Scientific Session Together with the World Congress of Cardiology, the beginning of the month saw a significant influx of new data related to contemporary management strategies, investigational therapies, and more. Later in the month, the community received new guidelines from major organizations and saw the approval of an agent for a difficult-to-manage treatment in pediatric populations.
In this cardiology month in review, we provide an overview of the top headlines from ACC.23 and offer summaries of the other top news in the field from the past month.
On the final day of the meeting, Paul Ridker, MD, presented data from a collaborative analysis of 3 major trials aimed at examining the impact of residual inflammation, as measured via high-sensitivity C-reactive protein (hsCRP), on cardiovascular risk in patients with atherosclerotic cardiovascular disease on statin therapy. Results of the study, which pooled data from the PROMINENT, STRENGTH, and REDUCE-IT trials, suggested residual inflammation was associated with a 30% increase in relative risk of cardiovascular events and a more than doubling in risk of cardiovascular and all-cause mortality in fully adjusted analyses accounting for LDL-C and residual cholesterol risk.
To most in the community, the advent of PCSK9 inhibitors was hailed as among the most significant advances in lipidology since the turn of the century. At the time, few could have imagined this injectable LDL-lowering therapy could ever be administered as an oral medication. At ACC.23, a phase 2 trial challenged that idea.
In the trial, use of MK-0616, an oral PCSK9 inhibitor, was associated with percent change from baseline in LDL-C at Week 8 of -41.2%, -55.7%, -59.1%, and -60.9% for 6 mg, 12 mg, 18 mg, and 30 mg groups, respectively, when compared against placebo therapy (P for all <.001).
Perhaps the most anticipated trial data scheduled to be presented at ACC.23, CLEAR Outcomes is the cardiovascular outcomes trial of bempedoic acid, which became the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 when it received approval in February 2020. A double-blind, randomized, placebo-controlled trial, CLEAR Outcomes randomized 13,970 and had a primary endpoint of 4-point MACE, which was defined as a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.
During a median follow-up of 40.6 months, use of the first-in-class, ATP citrate lyase inhibitor was associated with a significantly lower risk of the primary endpoint relative to than with placebo therapy (HR, 0.87 [95% CI, 0.79-0.96]; P=.004). Further analysis indicated there were no statistically significant reductions were observed for cardiovascular mortality (HR, 1.04 [95% CI, 0.88-1.24]) or all-cause mortality (HR, 1.03 [95% CI, 0.90-1.18]) within the trial.
At ACC.23, data from the REDWOOD trial Cohort 4 shed light on the safety and efficacy of aficamten in patients with non-obstructive hypertrophic cardiomyopathy. Results from this cohort, which included 41 patients, demonstrate aficamten was associated with significant improvements in NT-proBNP, which decreased by a mean of 66% (P <.0001), and hs-cTnI levels, which decreased significantly at each study visit (P <.05).
Analysis of secondary endpoints revealed an improvement of at least 1 NYHA functional class was observed among 54% of patients in the cohort, with 2 patients improving from NYHA class III to NYHA class I. Included in this article is a video interview with lead investigator Ahmad Masri, MD, MD, director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University.
Not long after ACC.23, Erin Michos, MD,associate professor of medicine within the Division of Cardiology and director of Women’s Cardiovascular Health at Johns Hopkins School of Medicine, visited the MJH Life Sciences studio. During her visit, the HCPLive editorial staff sat down with Michos to discuss her top takeaways in the world of lipidology from the conference.
In the interview, Michos discusses her reaction to YELLOW III, the Personalized Clinical Decision Support Intervention to Improve Statin Prescribing in Patients with Atherosclerotic Cardiovascular Disease trial, MK-0616, and CLEAR Outcomes.
On March 22, Regeneron announced the FDA approval of evinacumab-dgnb (Evkeeza) for use as an adjunct to other lipid-lowering therapies for lowing LDL-C caused by homozygous familial hypercholesterolemia in children aged 5-11 years old.
The first angiopoietin-like 3 (ANGPTL3) inhibitor treatment to receive such an indication, the approval comes just over 2 years after the agent received a similar approval in people aged 12 years and older in February 2021 and the current approval is based on a 3-part, single-arm trial conducted in this age group.
On March 27, the Society for Cardiovascular Angiography and Interventions and the Heart Rhythm Society collaborated to release updated guidance for transcatheter left atrial appendage. The guidelines, which were endorsed by the American College of Cardiology and the Society of Cardiovascular Computed Tomography, represent the first updated guidance from these organizations since 2015 and 2016.
On March 21, the American Heart Association and American College of Cardiology released a joint scientific statement outlining an overview of contemporary evidence related to supervised exercise training for people with heart failure with preserved ejection fraction.
In the statement, the writing committee, which was led by Vandana Sachdev, MD, of the NHLBI, provides insight into available data on exercise therapy and concluded had comparable or better results on improving exercise capacity for people with preserved EF compared to those with HFrEF.
March 29, 2023 marked the 10-year anniversary of the FDA’s approval of canagliflozin as an adjunct to diet and exercise for improving glycemic control in type 2 diabetes. The first agent in the class to receive approval, the regulatory decision would set the stage for what many consider to be the most significant therapeutic advance of the century in Cardiometabolic Health.
In this feature, we capture the perspective of key opinion leaders in diabetes, heart failure, and chronic kidney disease as they reflect on the journey of SGLT2 inhibitors into the cardiometabolic spotlight and major guidelines for each condition.