Padmastuti Akella, MD
Critical Care Physician
USF/TGH/Moffitt Cancer Center, United States
Disclosure information not submitted.
Jing Tao, MD
Dr.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Disclosure information not submitted.
Stephen Pastores, MD, MACP, FCCP
Program Director, Critical Care Medicine
Memorial Sloan Kettering Cancer Center
New York, NY, United States
Disclosure information not submitted.
Title: Thromboembolic Risk of Four-Factor Prothrombin Complex Concentrate in Cancer Patients
Introduction: Four-factor prothrombin complex concentrate (4F-PCC) is used for urgent reversal of life-threatening bleeding from vitamin K antagonists and direct oral anticoagulants (DOAC). Its advantages relative to fresh frozen plasma (FFP) include high levels of vitamin K dependent coagulation factors, lower infusion volumes, and minimal risks of transfusion related complications. However, 4F-PCC may carry a higher thromboembolism (TE) risk particularly in patients with significant risk factors for thrombosis. TE rates after 4F-PCC use is reported up to 8% in warfarin and DOAC reversal and 5% in trauma patients. To date, no TE data exists for 4F-PCC use in cancer patients, who are predisposed to both bleeding and thrombosis.
Methods: This is a single center retrospective study of venous and arterial TE in patients who received 4F-PCC for massive hemorrhage and/or anticoagulation reversal prior to emergent surgery between 2014 and 2017. Thromboembolic events were included it they occurred within 14 days of 4F-PCC administration. Data was analyzed using point estimates to approximate the rate of thrombosis.
Results: A total of 64 patients received 4F-PCC. 20 (31%) patients had hematological malignancies, and 44 (69%) had solid malignancies. 31 (48%) patients had a history of TE. Indications for 4F-PCC were anticoagulation reversal in 42%, bleeding unrelated to anticoagulation in 41% and surgery in 11%. Median dose of 4F-PCC administered was 30 (6.1-68.5) U/kg. 11 (17%) patients had TE within 14 days of receiving 4F-PCC, 10 (91%) venous and 1 (9%) arterial event. 7 of these 11 patients (64%) had a history of TE. TE occurred 1-9 days after 4F-PCC. Compared to patients who did not have TE, more patients in the TE group had solid malignancies, received 4F-PCC for anticoagulation reversal (73% vs 36%), and received a lower dose of 4F-PCC (30 vs 34 U/kg). Both groups had similar use of FFP and DVT prophylaxis.
Conclusions: Our preliminary data suggest that patients with cancer, especially those with a history of TE may have a significantly increased risk of TE after 4F-PCC. Dose of 4F-PCC does not appear to impact rate of TE occurrence.