Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F25%3A00085763" target="_blank" >RIV/00023001:_____/25:00085763 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S2213177925001702?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S2213177925001702?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jchf.2025.01.017" target="_blank" >10.1016/j.jchf.2025.01.017</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy

Popis výsledku v původním jazyce

Background: ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) demonstrated that aspirin avoidance with a fully magnetically levitated HeartMate 3 (HM3) left ventricular assist device (LVAD) reduces bleeding complications and does not increase thromboembolism. Whether a concomitant surgical procedure modifies the observed safety and benefits remains uncertain. Objectives: This prespecified analysis of ARIES-HM3 studied clinical outcomes when concomitant surgical procedures are performed during LVAD implantation with excluding aspirin but maintaining a vitamin K antagonist. Methods: Among 628 patients randomized to receive either placebo or aspirin with a vitamin K antagonist, 589 (296 placebo and 293 aspirin) contributed to the primary endpoint analysis. Sub-categorization with receiving a concomitant surgical procedure (valvular procedure/coronary artery bypass grafting or nonvalvular procedure) was done and the composite primary endpoint of survival free from major nonsurgical (&gt;14 days postimplant) hemocompatibility-related adverse events at 12 months was assessed. Results: There were 155 (52%) and 145 (49%) concomitant procedures in placebo and aspirin arms, respectively. The percentage of subjects achieving primary endpoint success was higher with the placebo group in patients with a concomitant procedure, and no interaction was observed on primary outcomes between those with and without concomitant surgical procedures (P-int = 0.231, 0.298, and 0.735 for any procedure, valvular/coronary artery bypass grafting, and nonvalvular procedures, respectively). There was a similar reduction in nonsurgical major hemorrhagic events with placebo compared with aspirin, observed in patients with or without any concomitant procedure: 0.64 (95% CI: 0.44-0.94) and 0.66 (95% CI: 0.46-0.93). Conclusions: Our findings support the safety and efficacy of aspirin avoidance from the antithrombotic regimen in HM3 LVAD patients undergoing concomitant surgical procedures. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156). (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Název v anglickém jazyce

Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy

Popis výsledku anglicky

Background: ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) demonstrated that aspirin avoidance with a fully magnetically levitated HeartMate 3 (HM3) left ventricular assist device (LVAD) reduces bleeding complications and does not increase thromboembolism. Whether a concomitant surgical procedure modifies the observed safety and benefits remains uncertain. Objectives: This prespecified analysis of ARIES-HM3 studied clinical outcomes when concomitant surgical procedures are performed during LVAD implantation with excluding aspirin but maintaining a vitamin K antagonist. Methods: Among 628 patients randomized to receive either placebo or aspirin with a vitamin K antagonist, 589 (296 placebo and 293 aspirin) contributed to the primary endpoint analysis. Sub-categorization with receiving a concomitant surgical procedure (valvular procedure/coronary artery bypass grafting or nonvalvular procedure) was done and the composite primary endpoint of survival free from major nonsurgical (&gt;14 days postimplant) hemocompatibility-related adverse events at 12 months was assessed. Results: There were 155 (52%) and 145 (49%) concomitant procedures in placebo and aspirin arms, respectively. The percentage of subjects achieving primary endpoint success was higher with the placebo group in patients with a concomitant procedure, and no interaction was observed on primary outcomes between those with and without concomitant surgical procedures (P-int = 0.231, 0.298, and 0.735 for any procedure, valvular/coronary artery bypass grafting, and nonvalvular procedures, respectively). There was a similar reduction in nonsurgical major hemorrhagic events with placebo compared with aspirin, observed in patients with or without any concomitant procedure: 0.64 (95% CI: 0.44-0.94) and 0.66 (95% CI: 0.46-0.93). Conclusions: Our findings support the safety and efficacy of aspirin avoidance from the antithrombotic regimen in HM3 LVAD patients undergoing concomitant surgical procedures. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156). (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

JACC. Heart failure

ISSN

2213-1779

e-ISSN

2213-1787

Svazek periodika

13

Číslo periodika v rámci svazku

7

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

13

Strana od-do

"art. no. 102411"

Kód UT WoS článku

001533829800007

EID výsledku v databázi Scopus

2-s2.0-105002234818