Efficacy and safety of direct oral anticoagulants in intermediate-high risk pulmonary embolism: Results from a multidisciplinary multicenter prospective registry

Abstract

Data on the initiation of direct oral anticoagulants (DOAC) in patients with intermediate-high risk pulmonary embolism (PE) are lacking. We conducted a prospective multicentre multidisciplinary registry study aimed at: – describing the antithrombotic strategy in real-life practice at the acute phase of intermediate-high risk PE; – assessing efficacy and safety of DOACs vs. standard guidelines-recommended anticoagulation therapy. We enrolled all pts with acute PE hospitalized in 11 participating centers. Intermediate-high risk PE was defined according to the ESC guidelines (hemodynamic stability, echocardiographic signs of RV dysfunction, elevated cardiac biomarkers). Early prescription of DOAC was defined as DOAC-prescription within 24 h after PE diagnosis. Primary outcome was a clinical composite of in-hospital death from any cause and hemodynamic decompensation. All pts were followed for at least 6 months. From 09/2012 to 12/2016, 1056 pts were enrolled. Among 249 (23.6%) intermediate-high risk PE pts, 40 (16.1%) received DOAC and 209 (83.9%) received parenteral anticoagulation in the first 24 h. Active cancer and impaired kidney function were independently related to non-prescription of DOAC. NYHA functional class I or II was the only factor independently associated with use of DOAC. There was no difference between groups in terms of death or hemodynamic decompensation in-hospital (OR 0.18; 95% CI 0.02 to 1.39; P = 0.01). The rate of in-hospital death, hemodynamic decompensation, bleeding, and recurrent PE were also similar. At 6 months, groups did not differ significantly in terms of death, recurrent PE, bleeding, MI or stroke. Our registry suggests that DOACs are quite frequently given as initial treatment in the first 24 h after diagnosis in intermediate-high risk PE pts in clinical practice with promising safety and efficacy profiles compared to standard guidelines-recommended parenteral anticoagulation.