Abstract
AIMS: Major bleeding events in heart failure (HF) patients are poorly described. We sought to investigate the importance of major bleeding and its impact on outcomes in HF patients. METHODS AND RESULTS: We analysed incident bleeding and ischaemic events during a 3 year follow-up in 2910 HF outpatients included in a prospective multicentre registry. Major bleeding was defined as a Type ≥3 bleed using the Bleeding Academic Research Consortium definition. Ischaemic event was a composite of ischaemic stroke and myocardial infarction. Events were adjudicated by a blinded committee. At inclusion, most patients (89%) received at least one antithrombotic: anticoagulation (53.9%) and/or antiplatelet therapy (46.2%). Bleeding occurred in 111 patients {3 year cumulative incidence: 3.6% [95% confidence interval (CI) 3.0-4.3]} and ischaemic events in 102 patients [3 year cumulative incidence: 3.3% (95% CI 2.7-4.0)]. Most bleedings were Bleeding Academic Research Consortium 3a (32.5%) or 3b (31.5%). Most frequent sites of bleeding were gastrointestinal (40.6%) and intracranial (27.9%). Variables associated with bleeding were atrial fibrillation [hazard ratio (HR) = 2.63 (95% CI 1.66-4.19), P < 0.0001], diabetes [HR = 1.62 (95% CI 1.11-2.38), P = 0.012], and older age [HR = 1.19 per 10 year increase (95% CI 1.00-1.41), P = 0.049]. Anticoagulation use was associated with a two-fold increase in the bleeding risk. Bleeding events as well as ischaemic events were strongly associated with subsequent mortality [adjusted HRs: 5.67 (4.41-7.29), P < 0.0001 and 4.29 (3.18-5.78), P < 0.0001, respectively]. CONCLUSIONS: In HF outpatients, antithrombotics are widely used. Bleeding occurs at a stable rate of 1.2% annually (as frequent as ischaemic events) and is associated with a dramatic increase in mortality (at least as severe as ischaemic events). Most events occurred in patients receiving anticoagulation. Knowledge of these findings may help physicians to manage antithrombotics in HF patients.