American Heart Association

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Final ID: MDP1368

Long-term effectiveness and safety of mavacamten in a real-world, multi-center, global study: Preliminary results of COLLIGO-HCM from a diverse cohort in the United States

Abstract Body (Do not enter title and authors here): Introduction: The mavaCamten ObservationaL evIdence Global cOnsortium in hypertrophic cardiomyopathy (COLLIGO-HCM; ClinicalTrials.gov ID NCT06372457) is a multinational, multicenter observational research initiative aiming to describe the real-world outcomes of mavacamten for the treatment of obstructive HCM.

Aims: Describe the real-world effectiveness and safety of mavacamten, measured by echo measurements and NYHA class.

Methods: This retrospective study used data from medical records from two participating HCM centers in the US. Patient-level data was extracted to assess the effectiveness and safety of mavacamten post-treatment initiation through 60 weeks. Patient characteristics and outcomes were described, including echocardiogram measurements, New York Heart Association (NYHA) functional class, and safety.

Results: A total of 93 patients were treated with mavacamten (mean age 60.6 ± 13.9 years, 23.7% black, 57.0% female, and 77.4% NYHA class III at baseline) with a mean follow-up of 37.0 ± 28.1 weeks (Table). From baseline to week 60, 3 (3.2%) patients experienced temporary treatment discontinuation, and 3 (3.2%) discontinued mavacamten due to left ventricular ejection fraction (LVEF) <50%. By week 12, 77.1% of patients had improved by ≥1 NYHA class. The percentage increased to 89.5% by week 24 and remained stable through week 60. Mean changes from baseline in resting and Valsalva left ventricular outflow tract gradients were 31.8 ± 32.8 and 57.3 ± 47.3 mmHg, respectively, at week 24, and remained similar through week 60. Mean change in LVEF from baseline was 4.1 ± 7.1% at week 12 and remained largely unchanged through week 60 (Figure).

Conclusions: This study demonstrated the early and sustained effectiveness of mavacamten with one of the longest follow-ups to date, in a real-world population with a higher racial diversity and disease burden than those in the clinical trials. This data further substantiates the effectiveness and safety profile of mavacamten.
  • Macnamara, James  ( University of Texas Southwestern Medical Center , Dallas , Texas , United States )
  • Orlandi, Paula  ( Bristol Myers Squibb , Princeton , New Jersey , United States )
  • Li, Leanne  ( IQVIA , Durham , North Carolina , United States )
  • Pichardo, Angel  ( IQVIA , Durham , North Carolina , United States )
  • Bilen, Ozlem  ( Emory University , Atlanta , Georgia , United States )
  • Adler, Arnon  ( Toronto General Hospital , Toronto , Ontario , Canada )
  • Maor, Elad  ( Sheba Medical Center , Tel HaShomer , Ramat Gan , Israel )
  • Bastiaenen, Rachel  ( Guy’s and St Thomas’ NHS Foundation Trust , London , United Kingdom )
  • Gold, Matthew  ( Emory University , Atlanta , Georgia , United States )
  • Maksabedian Hernandez, Ervant  ( Bristol Myers Squibb , Princeton , New Jersey , United States )
  • Han, Xu  ( Bristol Myers Squibb , Princeton , New Jersey , United States )
  • Schuler, Patricia  ( Bristol Myers Squibb , Princeton , New Jersey , United States )
  • Salazar-mendiguchia, Joel  ( Bristol Myers Squibb , Princeton , New Jersey , United States )
  • Author Disclosures:
    James Macnamara: DO have relevant financial relationships ; Consultant:Lexicon:Past (completed) ; Consultant:Cytokinetics:Active (exists now) ; Consultant:Bristol Meyers Squibb:Active (exists now) | Paula Orlandi: No Answer | Leanne Li: No Answer | Angel Pichardo: DO NOT have relevant financial relationships | ozlem bilen: DO NOT have relevant financial relationships | Arnon Adler: DO NOT have relevant financial relationships | Elad Maor: No Answer | Rachel Bastiaenen: DO have relevant financial relationships ; Advisor:Bristol Myers Squibb:Active (exists now) ; Speaker:Medtronic:Past (completed) ; Advisor:Pfizer:Active (exists now) | Matthew Gold: No Answer | Ervant Maksabedian Hernandez: DO have relevant financial relationships ; Employee:Bristol Myers Squibb:Active (exists now) ; Individual Stocks/Stock Options:Amgen:Active (exists now) ; Individual Stocks/Stock Options:Bristol Myers Squibb:Active (exists now) ; Employee:Amgen:Past (completed) | Xu Han: DO NOT have relevant financial relationships | Patricia Schuler: DO have relevant financial relationships ; Employee:Bristol Myers Squibb:Active (exists now) | Joel Salazar-Mendiguchia: DO have relevant financial relationships ; Employee:Bristol Myers Squibb:Active (exists now) ; Individual Stocks/Stock Options:Bristol Myers Squibb:Active (exists now)
Meeting Info:

Scientific Sessions 2024

2024

Chicago, Illinois

Session Info:

Hypertrophy and Heart Failure

Monday, 11/18/2024 , 11:10AM - 12:35PM

Moderated Digital Poster Session

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