Direct Oral Anticoagulants: An Evaluation of the Safety and Efficacy in Cardiothoracic Transplant Recipients

Pasley, T.; Logan, A.T.; Brueckner, A.; Bowman-Anger, L.; Silverman, Andrew; Rumore, A.

doi:10.1016/j.healun.2019.01.765

Cited by 8 publications

(15 citation statements)

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“…This finding matches with published data showing reduced incidence of clinically relevant major bleeding and non‐major bleeding with apixaban versus rivaroxaban in non‐SOT patients with AF and VTE 13,14 . Additionally, this finding has been suggested in several preliminary analyses in SOT recipients 19,20 …”

Section: Discussionsupporting

confidence: 91%

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Less bleeding associated with apixaban versus other direct acting oral anticoagulation in solid organ transplant recipients

Salerno

Thornberg

Lange

et al. 2021

Clinical Transplantation

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Background The purpose of this study was to evaluate outcomes of bleeding and thrombosis resulting from the use of direct oral anticoagulants (DOACs) in a large cohort of solid organ transplant (SOT) recipients. Methods This was a single center, retrospective cohort study of adult kidney, heart, lung, and liver transplant recipients transplanted between August 2009 and May 2018. Patients were stratified into two groups: those who received apixaban (apixaban group) or those patients receiving either rivaroxaban or dabigatran (non‐apixaban group). The primary endpoint was the cumulative incidence of bleeding while receiving DOAC therapy. The secondary endpoints were incidence of major bleeding and thrombosis at any time while receiving DOAC therapy. Results A total of 106 patients were included; 70 patients received apixaban and 36 patients received non‐apixaban anticoagulation. Cumulative incidence of any bleeding was lower in the apixaban group compared to the non‐apixaban group at both 90 days (4.9% vs. 16.1%) and 180 days (11.4% vs. 24.9%, P = .034). Cumulative incidence of major bleeding (P = .686) and thrombosis (P = .515) were similar between groups. DOAC dosing congruent with the package insert(s) was associated with a lower risk of thrombosis. Conclusion Apixaban‐based anticoagulation was associated with a lower cumulative incidence of any bleeding compared to non‐apixaban DOACs.

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Section: Discussionsupporting

confidence: 91%

“…13,14 Additionally, this finding has been suggested in several preliminary analyses in SOT recipients. 19,20 The only factor independently associated with any bleeding in multivariate analysis was receipt of non-apixaban DOAC treatment. The exact reason for this association is not readily apparent.…”

Section: Discussionmentioning

confidence: 99%

Less bleeding associated with apixaban versus other direct acting oral anticoagulation in solid organ transplant recipients

Salerno

Thornberg

Lange

et al. 2021

Clinical Transplantation

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“…Within our analysis we found thrombotic and bleeding rates of 7.2% and 8%, respectively, at 12 months. While these event rates appear higher than what is seen in landmark trials outside of the transplant population, these rates appear comparable to other transplant studies of similar size 21,23,32 . Within our analysis, concomitant hemodialysis was associated with a reduced risk of thrombosis, but a higher risk for major bleeding.…”

Section: Discussionsupporting

confidence: 70%

“…While these event rates appear higher than what is seen in landmark trials outside of the transplant population, these rates appear comparable to other transplant studies of similar size. 21,23,32 Within our analysis, concomitant hemodialysis was associated with a reduced risk of thrombosis, but a higher risk for major bleeding. This observation is likely mediated by potential accumulation of drug, resulting in a possible decreased likelihood of treatment failure and increased risk of bleeding.…”

Section: Discussionmentioning

confidence: 71%

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

Rubido

Cooper

Donahue

et al. 2023

Clinical Transplantation

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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.

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“…Prior to 2020, reports on the DOAC use among SOT recipients were limited to single‐center, retrospective case series without control arms (Table 1). 17–42 Among the abstracts from ATC and ISHLT, the incidences of major bleeding (0%–23%) and composite bleeding (0%–37%) ranged widely, and the incidence of thrombotic events was also variable (0%–21%).…”

Section: Safety and Efficacy Of Doac In Solid Organ Transplantmentioning

confidence: 99%

Use of direct‐acting oral anticoagulants in solid organ transplantation: A systematic review

et al. 2020

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The use of direct‐acting oral anticoagulants (DOACs) has increased secondary to the mounting evidence for comparable efficacy and potentially superior safety to vitamin K antagonists (VKAs) in the general population. However, insufficient data regarding DOAC use in solid organ transplant (SOT) recipients and numerous pharmacokinetic and pharmacodynamic considerations limit their use in this highly selected patient population. A systematic review of recent clinical evidence on the safety and efficacy of DOACs compared to VKAs in SOT recipients was conducted. Additional considerations including transplant‐specific strategies for DOAC reversal and common pharmacokinetic/pharmacodynamic concerns were also reviewed. Although current evidence is limited to single‐center retrospective analyses, DOACs, especially apixaban, appear to be a safe and effective alternative to VKAs for SOT recipients with stable graft function and without drug‐drug interactions. Reliable data on DOAC reversal at the time of transplant surgery are lacking, and clinicians should consider idarucizumab, andexanet alfa, and other non‐specific reversal agents on an individual patient basis. There is no evidence supporting deviations from the Food and Drug Administration labeling recommendations for DOAC dosing in the setting of drug‐drug interactions, obesity, and renal function, especially in patients on hemodialysis.

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Direct Oral Anticoagulants: An Evaluation of the Safety and Efficacy in Cardiothoracic Transplant Recipients

Cited by 8 publications

References 0 publications

Less bleeding associated with apixaban versus other direct acting oral anticoagulation in solid organ transplant recipients

Less bleeding associated with apixaban versus other direct acting oral anticoagulation in solid organ transplant recipients

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

Use of direct‐acting oral anticoagulants in solid organ transplantation: A systematic review

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