After a Q1 filled with historic regulatory decisions, seismic levels of movement in the therapeutic pipeline, and noteworthy anniversaries, it would be hard to imagine a single specialty could be capable of maintaining such a breakneck pace of advancement throughout an entire year. However, the field of cardiology made it clear that was exactly what they intended to do as the onslaught of clinically relevant data and approvals continued through the month of April.

In our cardiology month in review, we spotlight the key news and updates that defined April 2024 for cardiology. The recap includes a look at FDA decisions and the most popular content from our on-site coverage of the American College of Cardiology’s 2024 Annual Scientific Sessions, which were held from April 6-8 in Atlanta, GA.

FDA News in Cardiology from April 2024

FDA Approves Abbott's Novel Dissolvable Stent Therapy for Peripheral Artery Disease

On April 29, 2024, the US Food and Drug Administration Abbott’s Esprit BTK Everolimus Eluting Resorbable Scaffold System for treating blocked arteries below the knee in patients with peripheral artery disease (PAD). This device, made of dissolvable material similar to sutures, offers a novel approach to addressing chronic limb-threatening ischemia below the knee, filling a crucial gap in available treatments.

The approval, announced by Abbott, follows data from the pivotal LIFE-BTK trial, presented at the Transcatheter Cardiovascular Therapeutics Conference in October 2023. This approval marks a significant advancement in addressing PAD, a condition affecting over 20 million Americans and associated with severe complications, including an elevated risk of amputation.

FDA Approves TriClip TEER System for Tricuspid Regurgitation

The approval of Abbott’s novel dissolvable stent marked the second cardiovascular approval for Abbott during April. Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system received approval from the US Food and Drug Administration for treating tricuspid regurgitation, announced on April 2, 2024. This decision follows positive outcomes of the TRILUMINATE trial and an endorsement from the FDA's Circulatory System Devices Panel. TRILUMINATE, a prospective randomized trial published in the New England Journal of Medicine in May 2023, demonstrated the effectiveness of TriClip in improving patient outcomes compared to medical therapy alone.

Recapping Q1 2024 FDA Decisions in Cardiology, with Deepak Bhatt, MD, MPH, MBA

With an interest in learning more about the community’s reaction to these approvals and how they influence care, we sat down with opinion leader Deepak Bhatt, MD, MPH, MBA, director of Mount Sinai Heart and the Dr. Valentin Foster Professor of Cardiovascular Medicine, for his perspective.

American College of Cardiology 2024 Annual Scientific Session

After the calendars turn over and the new year begins, the cardiology community’s first flagship meeting of the year is always the American College of Cardiology (ACC) Annual Scientific Session. This year’s meeting, ACC.24, drew more than 17,000 attendees between the conference’s virtual and in-person formatting. As part of our cardiology month in review for April 2024, we are highlighting the most popular stories from our coverage of the ACC’s annual meeting.

Experts' Perspectives: Advancements in Cardiomyopathy at ACC.24

In recent years, advancements in the treatment of cardiomyopathies have captivated the cardiology community. However, experts and opinion leaders in cardiomyopathy are quick to remind others this progress was not overnight and comes as the result of tireless efforts by colleagues and their predecessors dating back decades. In this video, we aggregate responses from a trio of leading experts in cardiomyopathy on their perspectives on the rapid pace of advancements in the last half-decade.

Safia Chatur, MD: Sacubitril/Valsartan Offers Benefit in HFrEF Across New KDIGO Risk Classes

In this video, we sit down with Safia Chatur, MD, to discuss the study that earned her the meeting’s coveted Young Investigator award. In the study, Chatur and team assessed the effects of sacubitril/valsartan from within the PARADIGM-HF across the spectrum of renal impairment based on the 2024 KDIGO guidelines, which were released in early March.

Results of the study indicated a positive treatment effect of sacubitril/valsartan was observed across risk classifications, with no significant variation observed for those considered low (HR, 0.66; 95% CI, 0.47 to 0.93), moderate (HR, 0.82; 95% CI, 0.58 to 1.16), or high or very high risk (HR, 0.96; 95% CI, 0.70 to 1.32; P for interaction = .31). For the renal outcome, relative treatment effects were consistent across the low (HR, 0.76; 95% CI, 0.51 to 1.11) and moderate (HR, 0.53; 95% CI, 0.33 to 0.84) KDIGO risk categories, but this effect was not observed in those considered as high or very high risk (HR, 0.66; 95% CI, 0.40 to 1.07; P for interaction = .50).

ACC.24 Clinical Trials Recap, with Deepak Bhatt, MD, MPH, MBA

Ahead of ACC.24 we spoke with Bhatt to preview the trials from late-breaking sessions he was looking forward to most as part of the meeting. As part of our post-conference coverage, we caught up with Bhatt to see what he considered to be the most impactful clinical trials to be presented at ACC.24. Bhatt’s list included EMPACT-MI, REDUCE-AMI, ULTIMATE DAPT, DanGer Shock, and AEGIS-II.

Empagliflozin Misses Primary Endpoint in Post-MI Patient Population, EMPACT-MI Trial

EMPACT-MI was designed as an event-driven, double-blind, randomized, placebo-controlled trial and randomized 6522 patients in a 1:1 ratio to empagliflozin or placebo in addition to standard of care within 14 days of admission for an acute myocardial infarction. The primary outcome of interest for the EMPACT-MI trial was a composite of first hospitalization for heart failure and all-cause mortality assessed in a time-to-first-event analysis.

Results of the primary outcome analysis suggested a first heart failure hospitalization or death occurred among 9.1% (n=267) of the placebo arm and 8.2% (n=298) of the empagliflozin arms, with incidence rates of 6.6 and 5.5 events, respectively, per 100 patient-years (HR, 0.90; 95% CI, 0.76 to 1.06; P= .21). Analysis of individual components of the primary outcome indicated a first hospitalization for heart failure occurred among 4.7% (n=153) of the placebo arm and 3.6% (n=118) of the empagliflozin arm (HR, 0.77; 95% CI, 0.60 to 0.98).

Related: Don't Miss a Beat: EMPACT-MI at ACC.24, with Javed Butler, MD

HCPLive 5 at ACC.24

A new content offering embedded into our conference coverage for 2024 is the HCPLive 5. A video recap of our top 5 interviews from coverage, the HCPLive 5 for ACC.24 captured perspective in the areas of lipidology, cardiomyopathy, heart failure, and cardiovascular prevention. Our HCPLive 5 features perspective from the following:

• Christie Ballantyne, MD on the SHASTA-2 trial and plozasiran in severe hypertriglyceridemia.
• Martin Maron, MD on the IMPROVE-HCM trial and ninerafaxstat for nonobstructive hypertrophic cardiomyopathy.
• Sara Saberi, MD on recent advancement in pharmacotherapy within the management of HCM.
• Don't Miss a Beat featuring Javed Butler, MD, for a breakdown of the EMPACT-MI trial.
• Deepak Bhatt, MD, MPH, MBA with a recap of top trials and new data at ACC 2024, including the DanGer Shock trial.

Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others. Relevant disclosures for Greene include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others. Relevant disclosures for Butler include AstraZeneca, Bayer Healthcare, Boehringer Ingelheim Pharmaceuticals, Eli Lilly and Company, and others. Relevant disclosures for Bhatt include Amarin, AstraZeneca, Sanofi, Pfizer, Roche, Amgen, Eli Lilly and Company, and others.