Abstract

Bleeding is associated with higher risk of adverse outcomes in pulmonary embolism (PE). The “Bleeding Academic Research Consortium” (BARC) developed a classification of events combining laboratory & clinical parameters, but based on acute coronary syndrome patients. We investigated whether this classification is applicable in the context of PE, where no standard bleeding definition exists. Prospective, single-center registry of patients with confirmed PE. We excluded BARC types 1 or 4 bleeding, considered not to be applicable to the context of PE. BARC type 2 bleeds were defined as any overt bleeding requiring non-surgical or medical care, or leading to hospitalisation. Type 3 bleeds were defined as drop of >3 g/dL in haemoglobin, any transfusion, tamponnade, intra-cranial hemorrhage, or bleeding requiring surgical intervention. Type 5 bleeds were defined as any fatal bleed. From 2007 to 2011, 666 patients with confirmed PE were included; average age 66±18 years; 52% women; 25% low-risk, 61% intermediate-risk and 14% high-risk PE. Treatment was: unfractionated heparin in 93 (14%), enoxaparin in 200 (30%), fondaparinux in 373 (56%). Thrombolysis was given in 167 (25%). Sixty patients (9%) experienced bleeding (n=13, 43, 4 for BARC types 2, 3, 5 respectively). Main in-hospital events are shown in table 1. By multivariate analysis, independent predictors of in-hospital death were: cardiogenic shock (OR 12.6 [4.8-20.8]); chronic obstructive pulmonary disease (OR 5.27 [2.25-8.43]); acute right ventricular dysfunction (OR 2.98 [1.25-6.96]) and any bleeding (BARC 2,3,5) (OR 3.15 [1.34-7.37]). Our data suggest that the BARC classification can be applied to acute PE and that bleeding is associated with unfavourable in-hospital outcome. We suggest use of the BARC as the standard for classification of bleeding events in PE. Table Results BARC type 2 (A) BARC type 3/5 (B) No bleed (n=606) C) p (A) vs (C) p (B) vs (C) Death 2 (15.4%) 7 (15%) 19 (3.1%) 0.034 0.0014 Recurrent PE 0 4 (8.5%) 5 (0.9%) 0.67 <0.0001 Treatment escalation 1 (7.7%) 2 (4.2%) 4 (0.7%) 0.017 0.028

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