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Characteristics and outcomes in patients with atrial fibrillation receiving direct oral anticoagulants in off-label doses.


ABSTRACT: BACKGROUND:We evaluated adherence to dosing criteria for patients with atrial fibrillation (AF) taking dabigatran or rivaroxaban and the impact of off-label dosing on thromboembolic and bleeding risk. METHODS:We used data for a retrospective cohort from a large U.S. health plan for Medicare beneficiaries age?>?=65?years with AF who initiated dabigatran or rivaroxaban during 2010-2016. Stroke and major bleeding were quantified in patients who were eligible for low dose but received standard dose, and in patients who were eligible for standard dose but received low dose. RESULTS:We identified 8035 and 19,712 patients who initiated dabigatran or rivaroxaban, respectively. Overall, 1401 (17.4%) and 7820 (39.7%) patients who received dabigatran and rivaroxaban met criteria for low dose, respectively. Of those, 959 (68.5%) and 3904 (49.9%) received standard dose. In contrast, 1013 (15.3%) and 2551 (21.5%) of patients eligible for standard dose dabigatran and rivaroxaban received low dose. Mean follow-up for patients eligible for low and standard dose dabigatran and rivaroxaban were 13.9, 15.1, 10.1, and 12.3?months, respectively. In unadjusted analyses, patients eligible for low or standard dose dabigatran and rivaroxaban but receiving off-label dose, had no differences in the rates of ischemic stroke. Among patients who met criteria for standard dose direct oral anticoagulants (DOAC), use of low dose was associated with significantly higher risk of any major bleeding (Dabigatran: HR?=?1.44; 95% CI 1.14-1.8, P?=?0.002, Rivaroxaban HR 1.34, 95% CI 1.11-1.6, P?=?0.002) and gastrointestinal bleeding (Dabigatran: HR?=?1.48; 95% CI 1.08-2, P?=?0.016). In patients who met criteria for low dose DOACs, there was lower risk of major bleeding (Dabigatran: HR?=?0.59; 95% CI 0.43-0.8, P?

SUBMITTER: Briasoulis A 

PROVIDER: S-EPMC6998084 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Characteristics and outcomes in patients with atrial fibrillation receiving direct oral anticoagulants in off-label doses.

Briasoulis Alexandros A   Gao Yubo Y   Inampudi Chakradhari C   Alvarez Paulino P   Asleh Rabea R   Chrischilles Elizabeth E   Leira Enrique C EC   Vaughan-Sarrazin Mary M  

BMC cardiovascular disorders 20200203 1


<h4>Background</h4>We evaluated adherence to dosing criteria for patients with atrial fibrillation (AF) taking dabigatran or rivaroxaban and the impact of off-label dosing on thromboembolic and bleeding risk.<h4>Methods</h4>We used data for a retrospective cohort from a large U.S. health plan for Medicare beneficiaries age > =65 years with AF who initiated dabigatran or rivaroxaban during 2010-2016. Stroke and major bleeding were quantified in patients who were eligible for low dose but received  ...[more]

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