Real-world incidence of efficacy and safety outcomes in patients on direct oral anticoagulants with left ventricular systolic dysfunction at a tertiary referral center.

BACKGROUND: Patients with heart failure (HF) have increased risk for thromboembolic events. Real-world incidences of efficacy and safety outcomes of direct oral anticoagulants (DOACs) in patients with left ventricular systolic dysfunction (LVSD) are of growing clinical interest. HYPOTHESIS: Real-world efficacy and safety outcomes of DOACs in patients with LVSD will be similar to those of LVSD or HF subgroups in the RE-LY, ROCKET-AF, and ARISTOTLE trials.
METHODS: We performed a retrospective review of adult patients with LVSD (left ventricular ejection fraction ≤40%) on DOAC therapy between 2010 and 2016. Incidences of safety and efficacy outcomes of anticoagulation with DOACs were extracted from primary and secondary hospital discharge diagnoses.
RESULTS: DOACs were prescribed to 287 patients with LVSD over a mean follow-up of 313.3 ± 52.3 days. Many patients had moderate and severe chronic kidney disease (28.9% and 10.1%, respectively) and indications for anticoagulation therapy other than atrial fibrillation (19.9%). For efficacy outcomes, the calculated incidence rates of ischemic stroke and systemic embolism were 1.2 (95% confidence interval [CI]: 0.25-3.56) and 0.81 (95% CI: 0.10-2.94) events per 100 person-years, respectively. For the safety outcomes, incidence rates of GI bleeding and intracranial hemorrhage were 2.4 (95% CI: 0.8-5.3) and 0.41 (95% CI: 0.1-2.2) events per 100 patient-years, respectively.
CONCLUSIONS: Our findings are largely compatible with the results of LVSD or HF subgroups in RE-LY, ROCKET-AF, and ARISTOTLE trials and add to increasing confidence that DOACs can be safely used for stroke and systemic embolism prevention in patients with LVSD.

RCT Entities:   Population Interventions Outcomes