Physicians' Academy for Cardiovascular Education

High risk of ischemic and hemorrhagic events in AF patients with OAC contraindication

Patients With Atrial Fibrillation Who Are Not on Anticoagulant Treatment Due to Increased Bleeding Risk Are Common and Have a High Risk of Stroke

Literature - Redfors B, Gray WA, Lee RJ, et al. - JACC Clinical Electrophysiology 2017; published online ahead of print


OAC therapy effectively reduces the risk of ischemic stroke in AF patients, but comes with an increased risk of bleeding. Large trials of patients who did not have an increased baseline risk of bleeding have shown a favorable risk-to-benefit ratio with OACs [1-3]. However, important subsets of AF patients with a higher risk of bleeding were excluded from these trials.

In this study, in a real-world population the risk of ischemic stroke and major bleeding was assessed in AF patients who recently had a sufficiently severe bleeding event, such that OAC were considered contraindicated by their treating physician. Moreover, the aim was to identify subgroups in which these risks are increased.

For this purpose, patients (>18 years) with a diagnosis code for AF and a registered OAC contraindication were identified from the multi-payer Truven Health Market Scan Commercial and the Medicare Supplemental Research databases, from January 1, 2009, to December 31, 2013. Patients were required to have had ≥12 months of continuous enrollment after the index event, with the exception of patients who died in hospital. The primary study endpoint was the occurrence of ischemic stroke. Secondary endpoints were any stroke, hemorrhagic stroke, death from any cause, CV death, stroke-related death, and any major non-intracranial bleeding (requiring transfusion or surgical intervention). The stroke risk, as well as the bleeding risk, were compared with the adjusted risks for a general population of AF patients reported in literature [4-7].

Main results


A considerable number of patients with AF are not treated with OAC because of a bleeding-related contraindication, although they are considered to have high stroke risk according to their CHADS₂ or CHA₂DS₂-VASc score. These data show that these OAC-naive patients have a considerably high risk of ischemic and hemorrhagic stroke events, as well as death, and these risks are particularly high in patients with previous intracranial hemorrhage. These results suggest that new ways to prevent stroke are needed in this population.


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