2020 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants

Tomaselli, Gordon F.; Mahaffey, Kenneth W.; Cuker, Adam; Dobesh, Paul P.; Doherty, John U.; Eikelboom, John W.; Florido, Roberta; Gluckman, Tyler J; Hucker, William J.; Mehran, Roxana; Messé, Steven R.; Perino, Alexander C.; Rodríguez, Fátima; Sarode, Ravindra; Siegal, Deborah; Wiggins, Barbara S.

doi:10.1016/j.jacc.2020.04.053

Cited by 244 publications

(303 citation statements)

References 107 publications

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“…Anti–factor Xa levels can be utilized to assess on‐therapy or supratherapeutic levels if this calibration is performed (Table 4). 43,45 …”

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

“…The American College of Cardiology recommendations stratify duration of DOAC interruption based on the bleeding risk of the procedure and also CrCl as many DOACs have some degree of renal elimination (Table 5). 14,45 …”

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

“…Currently, guidance from the Anticoagulation Forum and 2020 American College of Cardiology (ACC) Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants recommends using idarucizumab 5 g intravenous (IV) for first‐line dabigatran reversal with aPCC 50 units/kg IV as an alternative therapy 45,64 . Based on currently available literature, in the setting of the need for DOAC reversal in transplant recipients, idarucizumab should be first‐line with aPCC as a secondary substitute for reversal.…”

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

“…Guidance from the Anticoagulation Forum and 2020 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants recommends using andexanet alfa for first‐line oral factor Xa reversal with 4F‐PCC utilization (2000 units fixed dose) as an alternative therapy 45,64 . Utilization of andexanet alfa in the setting of transplant reversal should be carefully considered and perhaps avoided based on the current paucity of literature and potential thrombosis risk.…”

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

“…Summary of the reversal of direct oral anticoagulants (adapted guidance from the anticoagulation forum and 2020 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants) 45 …”

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

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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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“…Anti–factor Xa levels can be utilized to assess on‐therapy or supratherapeutic levels if this calibration is performed (Table 4). 43,45 …”

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

Section: Periprocedural Management and Reversal Of Doac Therapymentioning

confidence: 99%

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

et al. 2020

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Efficacy and Safety Considerations With Dose-Reduced Direct Oral Anticoagulants

et al. 2022

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IMPORTANCE Dose-reduced regimens of direct oral anticoagulants (DOACs) may be used for 2 main purposes: dose-adjusted treatment intended as full-intensity anticoagulation (eg, for stroke prevention in atrial fibrillation [AF] in patients requiring dose reduction) or low-intensity treatment (eg, extended-duration treatment of venous thromboembolism [VTE]). We reviewed randomized clinical trials (RCTs) to understand the scenarios in which dose-adjusted or low-intensity DOACs were tested and reviewed the labeled indications by regulatory authorities, using data from large registries to assess whether the use of dose-reduced DOACs in routine practice aligned with the findings of RCTs. OBSERVATIONS Among 4191 screened publications, 35 RCTs that used dose-adjusted DOACs were identified for dabigatran, apixaban, rivaroxaban, and edoxaban. Of these 35 RCTs, 29 were related to stroke prevention in AF. Efficacy and safety results for dose-adjusted DOACs in large RCTs of AF were similar to those found for full-dose DOACs. To our knowledge, dabigatran, apixaban, and rivaroxaban have not been studied as dose-adjusted therapy for acute VTE treatment. Low-intensity DOACs were identified in 37 RCTs. Low-intensity DOACs may be used for extended-duration treatment of VTE (apixaban and rivaroxaban), primary prevention in orthopedic surgeries (dabigatran, apixaban, and rivaroxaban), primary prevention in ambulatory high-risk cancer patients (apixaban and rivaroxaban) or (postdischarge) high-risk medical patients (rivaroxaban), in stable atherosclerotic vascular disease, or after a recent revascularization for peripheral artery disease in conjunction with aspirin (rivaroxaban). Minor variations exist between regulatory authorities in different regions regarding criteria for dose adjustment of DOACs. Data from large registries indicated that dose-reduced DOACs were used occasionally with doses or for clinical scenarios different from those studied in RCTs or recommended by regulatory authorities.CONCLUSIONS AND RELEVANCE Dose adjustment and low-intensity treatment are 2 different forms of dose-reduced DOACs. Dose adjustment is mostly relevant for AF and should be done based on the approved criteria. Dose adjustment of DOACs should not be used for acute VTE treatment in most cases. In contrast, low-intensity DOACs may be used for primary or secondary VTE prevention for studied and approved indications. Attention should be given to routine practice patterns to align the daily clinical practice with existing evidence of safety and efficacy.

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Availability of Specific Direct Oral Anticoagulant Reversal Agents in US Hospitals

2021

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Direct oral anticoagulants (DOACs) are widely prescribed but associated with risk of major hemorrhage. Specific reversal agents have been developed for dabigatran (idarucizumab) and factor Xa inhibitors (andexanet alfa). Consensus statements from several 1-3 but not all 4 major organizations recommend these specific reversal agents, if available, over alternatives, such as prothrombin complex concentrates (PCC), in DOAC-associated life-threatening bleeding. Given the importance of timely reversal in life-threatening hemorrhage, we assessed the availability of specific DOAC reversal agents in US hospitals. MethodsThis cross-sectional study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline and was deemed non-human participant research and exempt from review by the Beth Israel Deaconess Medical Center Committee on Clinical Investigation. We used the Medicare Hospital Compare database to find eligible hospitals in the United States that provide emergency care, excluding those in territories, those operated by the Department of Defense, and those primarily designated as pediatric or psychiatric facilities. We searched each included hospital on pharmaceutical company drug locator websites for idarucizumab and andexanet alfa to assess whether they did or did not have access to each drug. Searches were conducted on manufacturer websites between

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2020 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants

Cited by 244 publications

References 107 publications

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

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

Efficacy and Safety Considerations With Dose-Reduced Direct Oral Anticoagulants

Availability of Specific Direct Oral Anticoagulant Reversal Agents in US Hospitals

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