Bleeding Risk and Antithrombotic Strategy in Patients With Sinus Rhythm and Heart Failure With Reduced Ejection Fraction Treated With Warfarin or Aspirin

• Published in: The American journal of cardiology 2015-09, Vol.116 (6), p.904-912
• Main Authors: Ye, Siqin, MS, MD, Cheng, Bin, PhD, Lip, Gregory Y.H., MD, Buchsbaum, Richard, Sacco, Ralph L., MD, Levin, Bruce, PhD, Di Tullio, Marco R., MD, Qian, Min, PhD, Mann, Douglas L., MD, Pullicino, Patrick M., MD, Freudenberger, Ronald S., MD, Teerlink, John R., MD, Mohr, J.P., MD, Graham, Susan, MD, Labovitz, Arthur J., MD, Estol, Conrado J., MD, PhD, Lok, Dirk J., MD, Ponikowski, Piotr, MD, PhD, Anker, Stefan D., MD, PhD, Thompson, John L.P., PhD, Homma, Shunichi, MD
• Format: Article
• Language: English
• Subjects: Aged; Anticoagulants - adverse effects; Aspirin; Aspirin - adverse effects; Blood clots; Cardiac arrhythmia; Cardiovascular; Embolisms; Female; Fractions; Heart attacks; Heart failure; Heart Failure - complications; Heart Failure - drug therapy; Heart Failure - physiopathology; Hemorrhage - chemically induced; Humans; Hypertension; Liver; Male; Middle Aged; Platelet Aggregation Inhibitors - adverse effects; Proportional Hazards Models; Risk Assessment; Stroke; Stroke - etiology; Stroke - prevention & control; Stroke Volume - physiology; Ventricular Dysfunction, Left - complications; Ventricular Dysfunction, Left - drug therapy; Ventricular Dysfunction, Left - physiopathology; Warfarin - adverse effects
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2015.06.016

We sought to assess the performance of existing bleeding risk scores, such as the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly (HAS-BLED) score or the Outpatient Bleeding Risk Index (OBRI), in patients with heart failure with reduced ejection fraction (HFrEF) in sinus rhythm (SR) treated with warfarin or aspirin. We calculated HAS-BLED and OBRI risk scores for 2,305 patients with HFrEF in SR enrolled in the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction trial. Proportional hazards models were used to test whether each score predicted major bleeding, and comparison of different risk scores was performed using Harell C -statistic and net reclassification improvement index. For the warfarin arm, both scores predicted bleeding risk, with OBRI having significantly greater C -statistic (0.72 vs 0.61; p = 0.03) compared to HAS-BLED, although the net reclassification improvement for comparing OBRI to HAS-BLED was not significant (0.32, 95% confidence interval [CI] −0.18 to 0.37). Performance of the OBRI and HAS-BLED risk scores was similar for the aspirin arm. For participants with OBRI scores of 0 to 1, warfarin compared with aspirin reduced ischemic stroke (hazard ratio [HR] 0.51, 95% CI 0.26 to 0.98, p = 0.042) without significantly increasing major bleeding (HR 1.24, 95% CI 0.66 to 2.30, p = 0.51). For those with OBRI score of ≥2, there was a trend for reduced ischemic stroke with warfarin compared to aspirin (HR 0.56, 95% CI 0.27 to 1.15, p = 0.12), but major bleeding was increased (HR 4.04, 95% CI 1.99 to 8.22, p