Novel study finds aspirin-free regimen benefits patients with LVAD
- Date:
- November 29, 2023
- Source:
- University of North Carolina Health Care
- Summary:
- The ARIES-HM3 Randomized Clinical Trial assessed the safety and efficacy of excluding aspirin from the antithrombotic regimen in patients with advanced heart failure who have undergone implantation of a fully magnetically levitated left ventricular assist device (LVAD). The clinical trial found that excluding aspirin from the antithrombotic regimen in patients with a levitated left ventricular assist device was safe.
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The ARIES-HM3 Randomized Clinical Trial assessed the safety and efficacy of excluding aspirin from the antithrombotic regimen in patients with advanced heart failure who have undergone implantation of a fully magnetically levitated left ventricular assist device (LVAD).
"We can now safely say that not giving aspirin is not only safe from a thromboembolic risk profile but results in improved adverse event rate by a significant reduction in non-surgical bleeding which is a well-known complication related to LVAD therapy," said Mirnela Byku, M.D., Ph.D., MBA, co-author of the study and director of the UNC Durable Mechanical Circulatory Device Program at the UNC School of Medicine. "Improving not only longevity but also reducing morbidity and improving quality of life is a big focus in the field of MCS."
Until this study, there had been no consensus in the field about use of or dose of aspirin in the LVAD population. The paper was published in JAMA.
The international clinical trial followed a randomized, double-blind, placebo-controlled design and involved 628 patients across 51 centers in 9 countries. The patients were divided into two groups: one receiving aspirin (100mg/d) and the other receiving a placebo in addition to vitamin K antagonist (VKA) therapy.
A focus was to determine if the likelihood a patient experiences major nonsurgical hemocompatibility-related adverse events (such as stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) within 12 months differed between the two groups.
The results showed not giving aspirin to patients with advanced heart failure, treated with a fully magnetically levitated LVAD who are receiving VKAs, did not make their survival worse. Furthermore, aspirin avoidance was associated with a significant reduction (34%) in major nonsurgical bleeding events.
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Materials provided by University of North Carolina Health Care. Note: Content may be edited for style and length.
Journal Reference:
- Mandeep R. Mehra, Ivan Netuka, Nir Uriel, Jason N. Katz, Francis D. Pagani, Ulrich P. Jorde, Finn Gustafsson, Jean M. Connors, Peter Ivak, Jennifer Cowger, John Ransom, Aditya Bansal, Koji Takeda, Richa Agarwal, Mirnela Byku, Michael M. Givertz, Abbas Bitar, Shelley Hall, Daniel Zimpfer, J. David Vega, Manreet K. Kanwar, Omar Saeed, Daniel J. Goldstein, Rebecca Cogswell, Farooq H. Sheikh, Matthew Danter, Yuriy Pya, Anita Phancao, John Henderson, Daniel L. Crandall, Kartik Sundareswaran, Edward Soltesz, Jerry D. Estep, Scott Silvestry, Antone Tatooles, Nasir Siulemanjee, Brett Sheridan, Sanjeev Gulati, Eugene Chung, Clement Delmas, Carmelo Milano, Pierre Dos Santos, Pavan Atluri, Douglas Horstmanshof, David D'Alessandro, Sriram Nathan, Peter Eckman, Anelechi Anyanwu, Anna Mara Scandroglio, Alessandro Ortalda, Ezequiel Molina, Jacob Abraham, Sern Lim, Robert Adamson, Ashwin Ravichandran, Christopher Hayward, William Hiesinger, John Entwistle, Jennifer Conway, Eric Adler, Jonathan Grinstein, Andreas Brieke, Mary Keebler, Jeffrey Alexis, Igor Gosev, Craig Selzman, David M Kaye. Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure. JAMA, 2023; DOI: 10.1001/jama.2023.23204
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