Evaluation of Patient Characteristics Linked to Major Bleeding Events in Patients Prescribed Direct Oral Anticoagulants.

INTRODUCTION: Direct oral anticoagulants (DOACs) demonstrated similar efficacy and lower risk of intracranial hemorrhage than warfarin in patients with atrial fibrillation and venous thromboembolism. Given the lack of data identifying risk factors in patients who bled while on a DOAC, we sought to investigate these characteristics. MATERIALS AND METHODS: This retrospective chart review was approved by the Mass General Brigham Institutional Review Board and assessed patients who experienced bleeding events while on DOAC therapy from 6/1/2015 to 7/1/2020. Patient characteristics were evaluated, including age, sex, body mass index (BMI), renal function, concomitant therapies, and baseline comorbidities. RESULTS: Eighty-seven patients were included for analysis, with a median age of 75.8 years. Most patients were female (51.7%) and 24 (27.6%) had a BMI >30. At time-of-event, 21 patients (24.1%) had acute kidney injury. Thirty-three patients (37.9%) were on concomitant antiplatelet therapy (APT), with 31 (35.6%) on single APT and 2 on dual APT. Pertinent comorbidities included hypertension (74.7%), ischemic cerebrovascular accident (28.7%), thyroid abnormality (23.0%), active cancer (14.9%), and anemia (13.8%). Eleven patients (12.6%) had a prior bleeding event. Most patients were on apixaban (69.0%) for the indication of stroke prevention in nonvalvular atrial fibrillation/flutter (72.4%). FDA-approved dosing was used in most patients (92.0%), and all deviations reflected underdosing. Most bleeding events were defined as major (95.4%), occurred at a critical organ site (72.4%), and developed spontaneously (58.6%). CONCLUSIONS: These data provide insight into characteristics of patients who experience bleeding events while on DOAC therapy. Understanding these potential risk factors may optimize the safe use of these agents.

Evaluation of Prescribing Practices and Outcomes Using Direct-acting Oral Anticoagulants After Cardiac Surgery.

PURPOSE: Cardiac surgery patients frequently require anticoagulation. Warfarin remains the preferred agent, and a few trials have reported negative outcomes with the use of direct-acting oral anticoagulants (DOACs) in these patients. Therefore, limited literature exists that supports the dosing, safety, and efficacy of DOACs within the cardiac surgery population. METHODS: This single-center, retrospective analysis was conducted at a tertiary academic medical center. All data were extrapolated from electronic medical records of qualifying patients from August 2017 to August 2019. Adult patients were included if they received at least 1 of 4 DOACs (apixaban, rivaroxaban, edoxaban, or dabigatran) after undergoing one of the following cardiac surgeries: coronary artery bypass graft, bioprosthetic valve replacement, aortic surgery, or valve repair. The composite safety end point included major bleeding and clinically relevant nonmajor bleeding, as defined by the International Society on Thrombosis and Hemostasis. The composite efficacy outcome of thromboembolic events included deep vein thrombosis, pulmonary embolism, ischemic stroke, and intracardiac thrombus. FINDINGS: A total of 305 patient charts were identified for analysis; 229 patients met the inclusion criteria. The composite safety outcome occurred in 12 patients (5.2%) within 90 days after cardiac surgery. One patient (0.4%) experienced a thromboembolic event within 90 days after cardiac surgery. The most commonly prescribed DOAC was apixaban (79.0%). US Food and Drug Administration-approved dosing was used in 91.3% of patients, and DOACs were primarily used for the indication of stroke prevention in atrial fibrillation or atrial flutter (88.2%). IMPLICATIONS: These data provide insight into the prescribing practices, efficacy, and safety of DOACs in cardiac surgery patients.