What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation undergoing percutaneous coronary intervention (n=623). Intervention: Direct oral anticoagulants vs. Appropriate dose. Primary outcome: Ischemic stroke (p=0.011).

What does this research mean for the field?

DOAC underdosing in atrial fibrillation patients undergoing percutaneous coronary intervention is associated with a higher frequency of ischemic stroke compared to appropriate dosing, with no significant difference in MACE or major bleeding events. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

December 19, 2024Circulation Journal9 citationsOpen Access

Impact of Underdosing of Direct Oral Anticoagulants on Clinical Outcomes in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

HKHideki KitaharaInterventional Cardiology TYTatsuro YamazakiTeikyo University Chiba Medical Center THTakashi HiragaKyoto University

Key Result

DOAC underdosing in AF patients undergoing PCI was associated with a higher frequency of ischemic stroke compared to appropriate dosing (log-rank P=0.011), with no difference in MACE or bleeding.

Study Design

Type

Cohort (n=623)

Multicenter

Yes

Structured PICO

Does underdosing of direct oral anticoagulants increase major adverse cardiovascular events or ischemic stroke in patients with atrial fibrillation undergoing percutaneous coronary intervention?

Population

623 patients with atrial fibrillation (AF) on direct oral anticoagulants (DOAC) undergoing percutaneous coronary intervention (PCI) using drug-eluting stents (DES), mean age 74-76, 78-85% male, across 15 institutions in Japan.

Intervention

Underdosing of direct oral anticoagulants (DOAC) (inappropriate low doses based on manufacturer labeling recommendations in Japan)

Comparator

Appropriate dosing of direct oral anticoagulants (DOAC) (appropriate low doses or appropriate standard doses based on manufacturer labeling recommendations in Japan)

Outcome

Cumulative incidence of major adverse cardiovascular events (MACE), a composite of all-cause mortality, non-fatal myocardial infarction, stent thrombosis, and ischemic stroke, within 1 year after PCIcomposite

Underdosing of direct oral anticoagulants in patients with atrial fibrillation undergoing PCI is associated with a significantly increased risk of ischemic stroke without providing any reduction in major bleeding events.

Main Result

p-value: p=0.011

Abstract

BACKGROUND: Underdoses of direct oral anticoagulants (DOAC) are sometimes prescribed due to bleeding risk concerns in patients with atrial fibrillation (AF). We investigated the prevalence of DOAC underdosing and its impact on clinical outcomes in AF patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: This multicenter observational cohort study enrolled patients with AF on DOAC undergoing PCI between January 2015 and March 2021 at 15 institutions across Japan. Clinical outcomes within 1 year, including major adverse cardiovascular events (MACE), all-cause mortality, ischemic stroke, and major bleeding events, were evaluated. Of 623 patients enrolled, 167 (26.8%) received underdoses, 224 (36.0%) received appropriate low doses, 210 (33.7%) received appropriate standard doses, and 22 (3.5%) received overdoses. Clinical outcomes were compared between patients with underdoses (n=167) and appropriate doses (n=434). Although the incidence of MACE, all-cause mortality, and major bleeding events did not differ significantly between the 2 groups (log-rank P=0.850, P=0.163, and P=0.711, respectively), ischemic stroke occurred more frequently in the underdose than appropriate-dose group (log-rank P=0.011). After propensity score matching, the same result was observed for the frequency of ischemic stroke (log-rank P=0.026). CONCLUSIONS: Compared with appropriate doses of DOAC, DOAC underdosing was associated with a higher incidence of ischemic stroke, despite no significant difference in MACE, all-cause mortality, and major bleeding events in AF patients undergoing PCI.

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