Abstract
Aims. Two thirds of patients with heart failure and preserved ejection fraction (HFpEF) have an indication for oral anticoagulation (OAC) to prevent thromboembolic events. However, evidence regarding the safety of OAC in HFpEF is limited. Therefore, our aim was to describe bleeding events and to find predictors of bleeding in a large HFpEF cohort. Methods and Results. We recorded bleeding events in a prospective HFpEF cohort. Out of 328 patients (median age 71 years (interquartile range (IQR) 67–77)), 64.6% (n = 212) were treated with OAC. Of those, 65.1% (n = 138) received vitamin-K-antagonists (VKA) and 34.9% (n = 72) non-vitamin K oral anticoagulants (NOACs). During a median follow-up time of 42 (IQR 17–63) months, a total of 54 bleeding events occurred. Patients on OAC experienced more bleeding events (n = 49 (23.1%) versus n = 5 (4.3%), p < 0.001). Major drivers of events were gastrointestinal (GI) bleeding (n = 18 (36.7%)]. HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score (hazard ratios (HR) of 2.15 (95% confidence interval (CI) 1.65–2.79, p < 0.001)) was the strongest independent predictor for overall bleeding. In the subgroup of GI bleeding, mean right atrial pressure (mRAP: HR of 1.13 (95% CI 1.03–1.25, p = 0.013)) and HAS-BLED score (HR of 1.74 (95% CI 1.15–2.64, p = 0.009)] remained significantly associatiated with bleeding events after adjustment. mRAP provided additional prognostic value beyond the HAS-BLED score with an improvement from 0.63 to 0.71 (95% CI 0.58–0.84, p for comparison 0.032), by C-statistic. This additional prognostic value was confirmed by significant improvements in net reclassification index (61.3%, p = 0.019) and integrated discrimination improvement (3.4%, p = 0.015). Conclusion. OAC-treated HFpEF patients are at high risk of GI bleeding. High mRAP as an indicator of advanced stage of disease was predictive for GI bleeding events and provided additional risk stratification information beyond that obtained by HAS-BLED score.
Highlights
Heart failure with preserved ejection fraction (HFpEF) accounts for half of all heart failure (HF) cases and is associated with considerable morbidity and mortality rates [1,2,3,4]
Since bleeding risk seems to be higher in HF patients as compared to non-HF controls [16], and a history of HF is rather a predictor of major bleeding than of thromboembolic risk [17], we aimed to describe bleeding events and find predictors of future hemorrhage in a large HFpEF cohort
Consecutive patients presenting with HFpEF between December 2010 and June 2018 were prospectively included in an observational registry established at the Department of Cardiology of the Medical University of Vienna
Summary
Heart failure with preserved ejection fraction (HFpEF) accounts for half of all heart failure (HF) cases and is associated with considerable morbidity and mortality rates [1,2,3,4]. Atrial fibrillation (AF) is present in approximately two thirds of HFpEF patients [5]. Precise risk stratification for both thromboembolic and bleeding risk is of high priority in order to identify patients in whom anti-thrombotic therapy would achieve maximum treatment benefit with the lowest risk of complications. Finding such a balance is challenging, since factors known to increase the risk of stroke have been identified to increase the risk of bleeding [12]
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