Key result
DOAC reversal protocol adherence drops below ~45% in urgent procedures, mainly driven by underdosing.
Why the study?
Adherence to protocols for the use of reversal agents in patients treated with DOACs in Dutch hospitals was not well evaluated.
What is the adherence to hospital protocols for the use of DOAC reversal agents in patients with bleeding or needing urgent procedures?
Cohort (n=290)
Yes
What is the adherence to hospital protocols for the use of DOAC reversal agents in patients with bleeding or needing urgent procedures?
Adherence to DOAC reversal protocols in Dutch hospitals is suboptimal, particularly for urgent procedures, highlighting the need for improved implementation strategies addressing underdosing and lack of specific lab testing.
Adherence gaps for urgent DOAC reversal signal implementation shortfalls; leaves open whether targeted interventions improve compliance or outcomes.
OBJECTIVES: This study aimed to evaluate the adherence to protocols for the use of reversal agents in direct oral anticoagulant (DOAC) users in Dutch hospitals. METHODS: A retrospective cohort study was conducted in seven hospitals in the Netherlands. Treatment protocols for bleeding and (urgent) procedures in patients on DOAC were collected from each hospital. All patient data on the use of reversal agents were retrospectively collected from September 2021 to April 2022 and compared to the protocols. The degree of per-protocol adherence (compliance score) was categorized into four levels as follows: poor (<45%), moderate (45-79%), high (80-89%), and full (> 90%) adherence rates. RESULTS: A total of 290 patients were included in our study. In patients with bleeding under DOAC, the protocol adherence for prothrombin complex concentrate (PCC) was "moderate" (61%). In the remaining cases (39%), non-adherence was mainly caused by underdosing (68%), overdosing (12%), and a lack of indication (14%). Furthermore, idarucizumab was administered for bleeding with "full" adherence (96%). For andexanet alfa, adherence to the hospital bleeding protocol was "moderate" (67%), with a lack of indication being the only reason for non-adherence. In case of reversal for an urgent procedure, the protocol adherence for PCC was "low" (45%), with underdosing, a lack of indication, and missing lab data being the main reasons for non-adherence. Missing lab data on dabigatran plasma concentration before reversal was the main reason for "low" adherence (26%) in idarucizumab. The adherence for andexanet alfa was also "low" (0%). CONCLUSION: In case of reversal for bleeding under DOAC, overall adherence to the protocol was "moderate"; however, in patients needing an urgent procedure, it was "low." The major reasons for non-adherence were underdosing, off-label use, and a lack of specific lab testing. The results of this study can assist in improving the implementation of hospital protocols.
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Mitrović et al. (2023) conducted a cohort in DOAC users requiring reversal agents (n=290). Reversal agents for direct oral anticoagulants was evaluated on Degree of per-protocol adherence (compliance score). Overall adherence to hospital protocols for DOAC reversal agents was moderate (61-96%) for bleeding but low (0-45%) for urgent procedures, mainly due to underdosing and missing lab data.
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