Key result
First bleeding event on VKAs for NVAF is linked to ~2-fold higher subsequent bleeding risk.
Why the study?
Little evidence existed on how a bleeding event in patients on vitamin K antagonists affects subsequent risks of bleeds, thromboembolic, and ischemic events to inform treatment decisions.
Does the occurrence of a first bleeding event increase the risk of subsequent bleeds and thromboembolic events in patients with NVAF on VKAs?
Cohort
Does the occurrence of a first bleeding event increase the risk of subsequent bleeds and thromboembolic events in patients with NVAF on VKAs?
In patients with NVAF on VKAs, a first bleeding event doubles the risk of subsequent bleeds without altering the risk of thromboembolic events, suggesting a need to reassess the risk-benefit balance of continued VKA therapy.
First bleed doubles subsequent bleeding risk without raising thromboembolic events in VKA-treated NVAF; leaves open whether to continue, switch, or deprescribe.
Background There is little evidence on how the occurrence of a bleed in individuals on vitamin K antagonists (VKAs) impacts the risk of subsequent bleeds, and thromboembolic and ischemic events. Such information would help to inform treatment decisions following bleeds. Objective To estimate the impact of bleeding events on the risk of subsequent bleeds, venous thromboembolism (VTE), stroke, and myocardial infarction (MI) among patients initiating VKA treatment for new-onset nonvalvular atrial fibrillation (NVAF). Methods We conducted an observational cohort study using a linked Clinical Practice Research Datalink—Hospital Episode Statistics dataset. Among a cohort of individuals with NVAF, the risk of clinically relevant bleeding, VTE, stroke, and MI was compared between the period prior to the first bleed and the periods following each subsequent bleed. The rate and cost of general practitioner (GP) consultations, prescriptions, and hospitalizations were also compared across these periods. Results The risk of clinically relevant bleeding events was observed to be elevated at least twofold in all periods following the first bleeding event. The risk of VTE, stroke, and MI was not found to differ according to the number of clinically relevant bleeding events. The rate and cost of GP consultations, GP prescriptions, and hospitalizations were increased in all periods relative to the period prior to the first bleed. Conclusions The doubling in the risk of bleeding following the first bleed, taken alongside the stable risk of MI, VTE, and stroke, suggests that the risk–benefit balance for VKA treatment should be reconsidered following the first clinically relevant bleed.
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Alikhan et al. (2019) conducted a cohort in New-onset nonvalvular atrial fibrillation (NVAF). Vitamin K antagonists (VKAs) vs. Period prior to the first bleed was evaluated on Clinically relevant bleeding, VTE, stroke, and MI (≥2-fold increase). Among patients on VKAs for NVAF, the risk of clinically relevant bleeding was elevated at least twofold following a first bleeding event, while the risk of VTE, stroke, and MI remained stable.
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