Treatment Patterns and Outcomes of Patients Receiving Direct Oral Anticoagulants or Low Molecular Weight Heparin who Experienced Life-threatening Intracranial Hemorrhage (P5.053)

Objective: There is a need to understand the real-world management, outcomes, and resource utilization of FXa inhibitor-associated major bleeding.

Background: Although Direct Oral Anticoagulants (DOACs), including factor Xa (FXa) inhibitors (rivaroxaban, apixaban, edoxaban, and enoxaparin), show lower rates of intracranial hemorrhage (ICH) than warfarin in clinical studies, ICH is still associated with high morbidity and mortality (up to 48% in clinical studies). There are no specific guidelines for managing these bleeds other than empirical institution-based hemorrhage protocols.

Design/Methods: Five US medical centers participated in a retrospective study of patients admitted to the hospital with life-threatening bleeding on or after January 2014 while on FXa inhibitor or low molecular weight heparin (LMWH). Baseline characteristics, treatment patterns, outcomes, and resource utilization were assessed. ICH patients were reviewed and are reported specifically.

Results: This chart review includes 56 major bleed patients, including 19 ICH. The majority of ICH were hypertensive [16(84.2%)], 6(35.3%) were on concomitant anti-platelet with FXa inhibitor, 6(31.6%) were diabetic and 5(26.3%) had a prior history of stroke. The known cause of the ICH was spontaneous [10(62.5%)] and trauma [6(37.5%)]. In the management of ICH bleeding, 73.7% of patients received coagulation/plasma products, whereas 26.3% received supportive interventions (e.g., radiological embolization). Mean (±SD) length of hospital stay was 8.1(11.2) days, and a median number of responsible physician specialties was 4. Mortality at 30 days post-discharge was 7(36.8%), with 5(26.3%) deaths during admission. No patients were readmitted within 30-day post-discharge, 4 patients were restarted on an anticoagulant at a mean (±SD) of 3.8(5.2) days post-discharge.

Conclusions: This study provides a real-world picture of patients receiving FXa inhibitors or LMWH, experiencing life-threatening intracranial bleeds. Despite efforts to restore hemostasis, mortality remained high and substantial healthcare resources were expended. This highlights the need to develop specific strategies for management of ICH in this patient population.

Study Supported by: Portola Pharmaceuticals, Inc.

Disclosure: Dr. Milling has received personal compensation for activities with CSI Behring, Janssen, BI, and Portola. Dr. Feronti has received research support from Portola. Dr. Clark has received research personal activities with Portola, Pfizer, Janssen, Cardiorentis, Ischemia Care Inc., and Radiometer. Dr. Fermann has received personal compensation for activities with Janssen and Pfizer as an advisory board member or speakers bureau member. Dr. Fermann has received research support from Novartis, Cardiorentis, Trevena, Siemens, Pfizer, Portola, Nanodetection, Radiometer, and Patient Centered Outcomes Research Institute. Dr. Song has received personal compensation for activities with Portola, Boehringer-Ingelheim, and Strykker as an advisor and/or consultant. Dr. Song has received personal compensation in an editorial capacity for AHA/ASA Stroke Journal and as an International Stroke Conference Abstract Reviewer. Dr. Song has received research support from Genentech and PRISMS. Dr. Torbati has nothing to disclose. Dr. Weiss has received personal compensation for activities with Portola as a consultant. Dr. Patel has received personal compensation for activities with Portola as a consultant. Dr. Neuman has received personal compensation for activities with Portola as an employee.