Safety and Effectiveness of Direct Oral Anticoagulants in AF Patients with Non-Mechanical Valves (SAFE VALVE)

Isabelle Greiss; Liliya Sinyavskaya; Alexis Matteau; Paolo Costi; Benoit Coutu; Fadi Mansour; Jean-Marc Raymond; Wouter St-Phard; Madeleine Durand

doi:10.1016/j.hrthm.2025.06.047

Safety and Effectiveness of Direct Oral Anticoagulants in AF Patients with Non-Mechanical Valves (SAFE VALVE)

Heart Rhythm. 2025 Jun 30:S1547-5271(25)02626-8. doi: 10.1016/j.hrthm.2025.06.047. Online ahead of print.

Authors

Isabelle Greiss¹, Liliya Sinyavskaya², Alexis Matteau³, Paolo Costi³, Benoit Coutu³, Fadi Mansour³, Jean-Marc Raymond³, Wouter St-Phard³, Madeleine Durand²

Affiliations

¹ Department of Cardiology, University of Montreal Hospital Center (CHUM), Montreal, QC, Canada. Electronic address: isabelle.greiss.med@ssss.gouv.qc.ca.
² Department of Internal Medicine, University of Montreal Hospital Center (CHUM), Montreal, QC, Canada.
³ Department of Cardiology, University of Montreal Hospital Center (CHUM), Montreal, QC, Canada.

PMID: 40602671
DOI: 10.1016/j.hrthm.2025.06.047

Abstract

Background: Direct oral anticoagulants (DOACs) have been studied in nonvalvular (NV) atrial fibrillation (AF). Data are lacking in AF patients with non-mechanical valves (NMV).

Objectives: We hypothesized that DOACs were safe and effective in AF patients with NMV.

Methods: A retrospective cohort study was designed within administrative healthcare databases. Cohort entry date was the first DOAC dispensation or 3 months following the NMV procedures. Follow-up was until the end of data availability or exposure to DOACs. Primary outcome was ischemic stroke or embolism. Secondary outcome was major bleeding. Event rates were compared to those in NVAF patients in the same databases and included in a meta-analysis.

Results: A total of 692 patients were included. Of those, 100 (14.4%) patients received dabigatran, 229 (33.1%) rivaroxaban and 363 (52.5%) apixaban. Due to low event incidence, data were pooled. There were 7 ischemic strokes/embolisms in 699 person-years, incidence rate of 1.00 per 100 person-years (95% CI: 0.48-2.10) and 12 major bleedings in 689 person-years, incidence rate of 1.74 per 100 person-years (95% CI: 0.99-3.07). NVAF cohorts demonstrated 554 ischemic strokes/embolisms in 6707.58 person-years, incidence rate of 0.83 per 100 person-years (95% CI: 0.76-0.90; P = .613) and 1907 major bleedings in 64178.27 person-year, incidence rate of 2.97 per 100 person-years (95% CI: 2.84-3.11; P = .065). Event rates were overlapping with other studies.

Conclusion: This is the largest cohort of AF patients with NMV and DOACs to be described. Based on low event rates, our data support prescribing of DOACs in such population.

Keywords: Anticoagulants; atrial fibrillation; bleeding; non-mechanical valves; thromboembolic events.