Hemocompatibility Outcomes With Pharmacological Therapy Following LVAD Implantation: Insights From the ARIES-HM3 Trial.

BACKGROUND

The ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) trial demonstrated safety and decreased bleeding in eliminating aspirin from the antithrombotic regimen of patients implanted with a HM3 left ventricular assist device (LVAD). Whether pharmacologic therapies impact hemocompatibility-related adverse events (HRAEs) remains uncertain.

OBJECTIVES

In this trial analysis, the authors investigated associations between pharmacologic therapy and hemocompatibility outcomes.

METHODS

Among 547 of 589 randomized patients who were discharged, non-inotrope-dependent, and completed 1-month of follow-up, the study explored the influence of pharmacotherapy (renin-angiotensin-aldosterone system [RAAS] inhibitors, heart failure [HF]-related and other cardiovascular drugs) on blood pressure control and on survival free of major nonsurgical HRAEs (stroke, pump thrombosis, bleeding, and arterial thromboembolism) at 12 months.

RESULTS

In 547 eligible patients, 65% received RAAS inhibitors, 89% received other HF-related therapy, and 82% received another cardiovascular drug at 1 month. No statistically significant interaction between RAAS inhibitors (P = 0.08), other HF-related therapies (P = 0.65), or other cardiovascular drugs (P = 0.92) on aspirin use and primary endpoint success was observed. Patients receiving RAAS inhibitors at 1 month had greater primary endpoint success (78.9% vs 69.3%, HR: 0.61 [95% CI: 0.37-1.01]; P = 0.14). Other HF-related therapies and cardiovascular drugs were not associated with primary event success either on or off prescription (HF-related therapy: 75.4% vs 76.7%; other cardiovascular drugs: 74.3% vs 81.3%). Pharmacologic therapy did not have a significant interaction with blood pressure control (RAAS inhibitors: P = 0.69; other HF-related therapy: P = 0.40).

CONCLUSIONS

Background pharmacologic therapy did not modify the effect of aspirin on HRAE; however, the use of a RAAS inhibitor was independently associated with a reduction in HRAE. These exploratory observations may potentially point to opportunity for enhancing hemocompatibility in patients receiving LVAD therapy. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156).