Cardiology Month in Review: February 2024

Living up to its billing as American Heart Month, February 2024 was an action-packed month for the field of cardiology. After a historic 2023, cardiology looked forward to more approvals, breakthroughs, and major data read-outs in 2024 and the field has delivered thus far through the first 2 months of the year. In our February 2024 cardiology month in review, we recap 3 pieces of FDA news, top new data from International Stroke Conference and major journals, and spotlighting perspectives form a bevy of key opinion leaders in the field on hot topics and news from across the spectrum of cardiovascular medicine.

FDA News in Cardiology

FDA Approves EVOQUE Tricuspid Valve Replacement System for Tricuspid Regurgitation

on February 2, 2024, Edwards Lifesciences Corporation announced has approved the ERVOQUE tricuspid valve replacement system for the treatment of tricuspid regurgitation (TR). The FDA’s approval of the device indicates it for improvement of health status in patients with symptomatic severe TR despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate, and represents the first transcatheter therapy to receive such an indication from the agency.

According to Edwards Lifesciences, the approval is based on data from the TRISCEND II trial and came nearly 5 years after the FDA granted the EVOQUE system a Breakthrough Designation in 2019 and less than 6 months after the system received a CE mark from the European Medicines Agency.

FDA Accepts NDA Submission for Acoramidis in ATTR-CM

On February 05, 2024, BridgeBio Pharma Incorporated announced the FDA’s acceptance of their New Drug Application for acoramidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). The company’s application is based on data from the phase 3 ATTRibute-CM trial and there are no plans for the FDA to hold an advisory committee meeting to discuss the application at this time. According to BridgeBio, the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024.

FDA Panel Votes in Favor of Abbott TriClip for Tricuspid Regurgitation

The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee met on February 13, 2024 for a discussion and vote on the benefit-risk profile of Abbott's TriClip for TR. The vote, which precedes an expected decision on the device’s approval sometime in 2024, centered around data from the TRILUMINATE trial and concluded in a 13 to 1 with no abstentions that the benefits of the system outweighed the risks for the treatment of TR based on data from the trial and expert testimony.

Top New Data in Cardiology

MOST: Blood Thinners Lack Improvement in Ischemic Stroke Outcomes

Presented at the American Stroke Association’s International Stroke Conference 2024, data from the Multi-Arm Optimization of Stroke Thrombolysis (MOST) trial suggest the addition of blood thinners to clot-busting medications did not improve 90-day outcomes among people with ischemic stroke.

A 3-arm study conducted at more than 50 hospitals in the US, the study was halted by a data safety monitoring board following an interim analysis of the first 500 enrolled patients indicating it was unlikely a benefit would be observed if the research was completed.

ARCADIA: Apixaban Not Superior to Aspirin in Reducing Recurrent Stroke Risk

Results from the ARCADIA randomized clinical trial demonstrated apixaban did not significantly reduce recurrent stroke risk compared with aspirin among patients with cryptogenic stroke and evidence of atrial cardiopathy without atrial fibrillation.

Results of the study indicated the primary outcome of recurrent stroke was identified in 40 patients in the apixaban group (annualized rate, 4.4%) and 40 patients in the aspirin group (annualized rate, 4.4%) (HR,1.00 [95% CI, 0.64 - 1.55]). A post-hoc analysis performed in 149 patients with AF documented after randomization also found no significant difference in the rate of recurrent stroke between apixaban (annualized rate, 1.8%) and aspirin (annualized rate, 2.2%) (HR, 0.84 [95% CI, 0.19 - 3.74]).

New Risk Score Outperforms Current Model, Could Improve Heart Transplant Allocation

A newly proposed risk score form investigators at the University of Chicago could reshape the allocation of hearts for transplant more equitably. Through an assessment 46 variables, including demographic, clinical, laboratory, and hemodynamic parameters, investigators developed the US candidate risk score (US-CRS), which, when assessed in a validation study, bested the conventional 6-status model and the French-CRS. In a related article, we spoke with Michelle Kittleson, MD, PhD, director of Education in Heart Failure and Transplantation at the Smidt Heart Institute at Cedars-Sinai, on the limitations of the current scoring system and benefits of this proposed system.

Related: Michelle Kittleson, MD, PhD: Need for Justice in Heart Transplant Allocation

Key Opinion Leader Perspective

During the month of February, cardiology took centerstage on HCPLive, with more than a dozen leading experts in the field appearing in videos, Q&As, or other multimedia content during American Heart Month. Many of these related to new studies, upcoming meetings, or discussions around pipeline development, but also came in the form of 2 features spotlighting the impact of subpar clinical trial diversity on public health. In this section, we acknowledge the bevy of KOL perspectives form cardiology hosted on the site during February 2024.

Deepak Bhatt, MD, MPH: 5 Late-Breaking Trials to Watch at ACC 2024

With less than 6 weeks until the American College of Cardiology 2024 Scientific Sessions, we spoke with Deepak Bhatt, MD, MPH, MBA, director of Mount Sinai Heart, to learn what late-breaking trials he was most excited to learn more about from the meeting. In the video, Bhatt offers perspective on EMPACT-MI, AEGIS-II, REDUCE-AMI, a MINT trial analysis, and ULTIMATE DAPT.

Ahmad Masri, MD, MS: 2024 Update on Development and Future of Cardiac Myosin Inhibitor Class

The development of the cardiac myosin inhibitor class has pushed the management of obstructive hypertrophic cardiomyopathy into the future, driven by advancements and revelations surrounding the effects of mavacamten and aficamten. Following a January 2024 review in the Canadian Journal of Cardiology discussing the history and latest updates within the class, our editorial team sat down with senior author Ahmad Masri, MD, MS, director of the Hypertrophic Cardiomyopathy Center at Oregon Health and Science University, for more perspective on the class and its future.

Experts' Perspectives: How Lacking Clinical Trial Diversity Impacts Public Health

In recognition of Black History Month, the editorial team of HCPLive reached out to experts in diversity and equity in healthcare from across 7 different specialties in medicine to capture how a lack of clinical trial diversity has had a deleterious downstream effect on care for people of color in real-world settings. The article linked above is the homepage of the 3-part series, which includes perspective from clinicians in cardiology, gastroenterology, nephrology, pulmonology, psychiatry, rheumatology, and sleep medicine.

Experts' Perspectives: Top Issue Facing Cardiology in 2024

Our final highlight for the month of February spotlights our American Heart Month feature. For 2024, in lieu of a more traditional approach, HCPLive posed a group of 9 cardiologists with a simple question: What is the top issue facing your specialty today?

Included in our group of expert perspectives are those of Michelle Kittleson, MD, PhD, of Cedars-Sinai, James Januzzi, MD, of Massachusetts General Hospital, Laxmi Mehta, MD, of Ohio State University Wexner Medical Center, Deepak Bhatt, MD, MPH, MBA, of Mount Sinai Heart, Ahmad Masri, MD, MS, of Oregon Health and Science University, Tom Nguyen, MD, of Miami Cardiac and Vascular Institute, Steve Greene, MD, of Duke University Medical Center, Viet Le, DMSc, PA-C, of Intermountain Heart Institute, and Lauren Sykes Eyadiel, MMS, PA-C, of Wake Forest University.