M Santibanez1, C A Lesch2, L Lin3, K Berger4. 1. NewYork-Presbyterian Hospital, Columbia University Irving Medical Center, Department of Pharmacy, 630 West 168 Street, New York, NY 10032, USA; NewYork-Presbyterian Hospital, Weill Cornell Medical Center, Department of Pharmacy, 525 E 68 Street (Room K-04), New York, NY 10065, USA. Electronic address: msantibanez@ularkin.org. 2. NewYork-Presbyterian Hospital, The Allen Hospital, Department of Pharmacy, 5141 Broadway, New York, NY 10032, USA. Electronic address: cal9005@nyp.org. 3. NewYork-Presbyterian Hospital, Columbia University Irving Medical Center, Department of Pharmacy, 630 West 168 Street, New York, NY 10032, USA; NewYork-Presbyterian Hospital, Weill Cornell Medical Center, Department of Pharmacy, 525 E 68 Street (Room K-04), New York, NY 10065, USA. 4. NewYork-Presbyterian Hospital, Weill Cornell Medical Center, Department of Pharmacy, 525 E 68 Street (Room K-04), New York, NY 10065, USA. Electronic address: kab9098@nyp.org.
Abstract
PURPOSE: Current guidelines favor 4F-PCC over plasma for warfarin reversal. Uncertainty remains on its thrombotic risk and hemostatic effectiveness when used for direct-acting oral anticoagulants (DOACs), transplants, massive transfusion protocols (MTP), and non-anticoagulated patients. This study sought to evaluate the tolerability and effectiveness of 4F-PCC in a real-world setting. MATERIALS AND METHODS: This was a retrospective study of adults who received 4F-PCC from March 2014 to December 2015. The primary outcome was thromboembolic events within 14 days. The secondary outcome was hemostatic effectiveness within 24 h. RESULTS: The final analysis included 212 patients. Primary reversal indication was major bleed in 165 patients (77.8%) and emergent surgery in 47 patients (22.2%). Thromboembolism occurred in 22 patients (10.4%), more in emergent surgery than major bleed reversals (17% and 8.5%, respectively). MTP and heart transplant patients had the highest thromboembolic event rates (44.4% and 28.6%, respectively). Hemostatic effectiveness was 65.8% (68% in major bleed and 58.1% in emergent surgery). DOAC patients achieved hemostasis most often (78.9%). Administration of any reversal agent, major surgery within 14 days, and MTP activation were significant predictors of thromboembolism. CONCLUSIONS: Use of 4F-PCC in this real-world setting was associated with variable thromboembolic and hemostatic effectiveness rates based on the indication for reversal.
PURPOSE: Current guidelines favor 4F-PCC over plasma for warfarin reversal. Uncertainty remains on its thrombotic risk and hemostatic effectiveness when used for direct-acting oral anticoagulants (DOACs), transplants, massive transfusion protocols (MTP), and non-anticoagulated patients. This study sought to evaluate the tolerability and effectiveness of 4F-PCC in a real-world setting. MATERIALS AND METHODS: This was a retrospective study of adults who received 4F-PCC from March 2014 to December 2015. The primary outcome was thromboembolic events within 14 days. The secondary outcome was hemostatic effectiveness within 24 h. RESULTS: The final analysis included 212 patients. Primary reversal indication was major bleed in 165 patients (77.8%) and emergent surgery in 47 patients (22.2%). Thromboembolism occurred in 22 patients (10.4%), more in emergent surgery than major bleed reversals (17% and 8.5%, respectively). MTP and heart transplant patients had the highest thromboembolic event rates (44.4% and 28.6%, respectively). Hemostatic effectiveness was 65.8% (68% in major bleed and 58.1% in emergent surgery). DOACpatients achieved hemostasis most often (78.9%). Administration of any reversal agent, major surgery within 14 days, and MTP activation were significant predictors of thromboembolism. CONCLUSIONS: Use of 4F-PCC in this real-world setting was associated with variable thromboembolic and hemostatic effectiveness rates based on the indication for reversal.
Authors: Charlie J Nederpelt; Leon Naar; Katelyn W Sylvester; Megan E Barra; Russel J Roberts; George C Velmahos; Haytham M A Kaafarani; Martin G Rosenthal; David R King Journal: J Thromb Haemost Date: 2020-08-27 Impact factor: 5.824