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 (>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 (Pint = 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).

Abbott Chicago Illinois USA

Ascension St Vincent Indianapolis Indiana USA

Department of Cardiothoracic Surgery Ochsner Clinic Foundation New Orleans Louisiana USA

Department of Medicine Brigham and Women's Hospital Harvard Medical School Boston Massachusetts USA

Division of Cardiology Columbia University Irving Medical Center New York Presbyterian Hospital New York New York USA

Division of Cardiology Department of Medicine NYU Grossman School of Medicine and Bellevue Hospital New York New York USA

Division of Cardiology Department of Medicine University of California San Diego San Diego California USA

Division of Cardiology Montefiore Medical Center Albert Einstein College of Medicine New York New York USA

Emory University Hospital Atlanta Georgia USA

Institute for Clinical and Experimental Medicine Prague Czech Republic

Kansas University Medical Center Kansas City Kansas USA

Research Department of University Medical Center Astana Kazakhstan

Rigshospitalet University of Copenhagen Copenhagen Denmark

Stollery Children's Hospital University of Alberta Edmonton Alberta Canada

The Lindner Research Center at The Christ Hospital Cincinnati Ohio USA

Thoracic and Cardiovascular Surgery Cleveland Clinic Cleveland Ohio USA

University of Chicago Chicago Illinois USA

University of Michigan Ann Arbor Michigan USA

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ClinicalTrials.gov
NCT04069156