Cardiology Month in Review: November 2024

The calendar year is winding to a close as the months change from November to December, but the field of cardiology is continuing to press on towards the future. In November 2024, the field welcomed mountains of new data and clinically relevant updates, including the field’s final flagship meeting and a historic approval from the US Food and Drug Administration.

In our Cardiology Month in Review for November 2024, we spotlight 13 pieces of content from the past month, including our most popular articles and video interviews from the American Heart Association’s Annual Scientific Sessions as well as a special episode of our expert-led diabetes podcast breaking down diabetes-specific news from the meeting.

FDA News and Pipeline Updates

FDA Approves Acoramidis (Attruby) for ATTR-CM

On November 22, 2024, BridgeBio Pharma announced FDA approval of acoramidis (Attruby) for transthyretin amyloid cardiomyopathy (ATTR-CM) in adults, marking it as the first therapy approved with a label specifying near-complete (≥90%) TTR stabilization.

The approval is based on results from the phase 3 ATTRibute-CM trial, which included 632 patients and demonstrated significant reductions in cardiovascular death and hospitalization. At 30 months, acoramidis showed a win ratio of 1.8 (95% CI, 1.4–2.2; P <.001) versus placebo, with a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalization events.

Check out this interview clip with ATTRibute-CM investigator Ahmad Masri, MD, MS, director of the Hypertrophic Cardiomyopathy Center at Oregon Health and Science University, for his perspective on what an approval would mean for patients, providers, and health systems.

FDA Accepts Alnylam’s sNDA for Vutrisiran for ATTR-CM

On November 25, 2024, Alnylam Pharmaceuticals announced the FDA's acceptance of a supplemental New Drug Application for vutrisiran for the treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM). The FDA has set a PDUFA target date of March 23, 2025, and will not convene an advisory committee meeting.

The submission is supported by data from the phase 3 HELIOS-B trial, which demonstrated a 28% relative risk reduction (HR, 0.72; P = .01) in all-cause mortality and recurrent cardiovascular events for vutrisiran versus placebo. Additional benefits included improved functional capacity (6-MWT: +26.5 meters; P <.001) and quality of life (KCCQ-OS: +5.8 points; P <.001), with safety outcomes consistent with the drug’s profile.

If approved, vutrisiran could become the first treatment indicated for both polyneuropathy and cardiomyopathy manifestations of transthyretin amyloidosis.

FDA Approves VARIPULSE Platform for Treatment of Atrial Fibrillation

On November 7, 2024, Johnson & Johnson MedTech announced FDA approval of the VARIPULSE pulsed field ablation (PFA) platform for drug-refractory paroxysmal atrial fibrillation. The VARIPULSE platform integrates PFA therapy with advanced 3D mapping capabilities of the CARTO 3 System, allowing for precise energy delivery and real-time catheter visualization.

The approval was based on 12-month data from the pivotal phase of the admIRE trial, which demonstrated 100% acute procedural success in 291 patients, with 85% achieving peak primary effectiveness. The platform also supports minimal- to zero-fluoro workflows through intracardiac echocardiography integration, enhancing safety and efficiency.

American Heart Association Annual Scientific Sessions 2024

Most Popular Articles

• SUMMIT Trial Proves Tirzepatide's Benefit in HFpEF with Obesity
• VANISH2: Catheter Ablation Viable First-Line Option for Ventricular Tachycardia
• Intensive Blood Pressure Regimen Lowers CVD Risk in People with T2D
• More than 50% of US Adults Considered Eligible for Semaglutide with Current Labeling
• Obesity-Related Heart Disease Deaths Rose Roughly 180% Since 1999

Most Popular Expert Interviews

• Finding a Role for GLP-1 RAs, Incretin Therapies in Heart Failure, with Muthiah Vaduganathan, MD, MPH
• Recent Advances Have Improved Prognosis in ATTR-CM Patients, with Ahmad Masri, MD, MS
• Oussama Wazni, MD, MBA: OPTION Trial and the Role of LAAC in Atrial Fibrillation
• Phase 2 Data Support Muvalaplin for Lowering Lp(a), with Stephen Nicholls, MBBS, PhD
• Navigating News and Updates in Cardiology at AHA 24, with Viet Le, PA-C, DMSc

Additional Content: Diabetes Dialogue: News and Updates in Diabetes at AHA 2024

Relevant disclosures for Masri include Cytokinetics, Bristol Myers Squibb, BridgeBio, Pfizer, Ionis, Lexicon, Attralus, Alnylam, Haya, Alexion, BioMarin, and AstraZeneca. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.