Descriptive analysis evaluating the use of direct oral anticoagulation therapy in heart and lung transplant recipients

Abstract

Background Direct oral anticoagulants (DOACs) are widely utilized following cardiothoracic transplantation with limited guidance regarding drug–drug interactions (DDIs), periprocedural management, and DOAC‐specific monitoring. Methods We performed a single‐center, retrospective, descriptive analysis of adult cardiothoracic transplant recipients initiated on DOAC therapy between May 2016 and July 2021. The primary endpoint for this analysis was the percentage of patients dosed per package labeling. Secondary endpoints included DOAC prescribing in the context of DDIs, renal dysfunction, and periprocedural management, as well as thromboembolism and major bleeding at 12 months. Results A total of 125 patients were included in this analysis with a median age of 62 years. At initiation, 63.2% of patients were dosed according to package labeling. The most common reason for non‐labeled dosing was concomitant azole antifungal therapy. DOAC therapy was held for 82 procedures with no reported thrombotic events and one major bleed in the setting of AKI. Hemodialysis‐dependence was associated with a reduced risk of thrombosis (0 vs. 10 events per 100 PY, p = .002) and an increased risk of major bleeding (23 vs. 8 events per 100 PY, p = .006). Additionally, DOAC‐specific anti‐xa guided dosing was associated with a reduced risk of major bleeding (0 vs. 13 events per 100 PY, p < .001). Conclusion Our findings show that deviation from package labeling is common following cardiothoracic transplantation and its association with clinical outcomes warrants further study.

Oral Anticoagulants after Heart Transplantation—Comparison between Vitamin K Antagonists and Direct Oral Anticoagulants

“…Clinical management of HTX recipients frequently involves the treatment of atrial arrhythmias or thromboembolic events implying the need for OACs [ 10 , 11 , 12 , 13 , 14 , 15 , 16 ]. However, data about OACs in HTX recipients, especially about the efficacy and safety of DOACs, are scarce and mainly based on case series or small sample size studies [ 17 , 18 , 19 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 ]. We, therefore, performed the largest known study about the frequency, indications, and complications of DOACs after HTX.…”

“…The primary goal of OACs is the prevention of thromboembolic stroke in patients with AF and the prevention of the progression or recurrence of thromboembolic events in patients with VTE [ 13 , 14 , 15 , 16 ]. Several studies have shown a comparable efficacy of DOACs in comparison to VKAs in the general population [ 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ] but data about the efficacy of DOACs after HTX are limited [ 17 , 18 , 19 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 ].…”

“…Given the lack of routine assessment of DOAC-specific anti-Xa activity, we could not perform further investigations to explore the use of DOAC-specific anti-Xa monitoring. However, data about the benefits of DOAC-specific anti-Xa monitoring in HTX recipients are rare and its clinical use is still the subject of debate [ 19 , 30 , 31 ].…”

“…In addition, several studies showed similar or even better efficacy and safety of DOACs over VKAs for the treatment of AF and VTE in the general population [ 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ]. However, data on the efficacy and safety of DOACs in HTX recipients are very limited as they are often derived from small sample-size studies [ 17 , 18 , 19 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 ].…”