Management and Outcomes of Anticoagulated Patients in Urgent Surgery: The PAUSE-ER Study
Recommended Citation
Siegal D, Arnaoutoglou E, Blostein M, Castellucci L, Eikelboom J, Gandhi R, Gross P, Kaatz S, Le Gal G, Schulman S, Shah V, Stamoulis K, Tafur A, Vogt K, Nixon J, St. John M, Karunakaran M, Levoy-Jones B, Douketis J. Management and Outcomes of Anticoagulated Patients in Urgent Surgery: The PAUSE-ER Study. Res Pract Thromb Haemost 2023; 7.
Document Type
Conference Proceeding
Publication Date
10-1-2023
Publication Title
Res Pract Thromb Haemost
Keywords
andexanet alfa, anticoagulant agent, apixaban, dabigatran, edoxaban, idarucizumab, prothrombin complex, rivaroxaban, tranexamic acid, vitamin K group, warfarin, adult, adverse drug reaction, adverse outcome, atrial fibrillation, best practice, bleeding, Canada, cohort analysis, complication, conference abstract, controlled study, drug combination, drug therapy, female, follow up, general anesthesia, general surgery, Greece, human, incidence, lung embolism, major clinical study, male, morbidity, observational study, side effect, special situation for pharmacovigilance, surgery, therapy, thromboembolism, urologic surgery
Abstract
Background: Few data describe the perioperative management and outcomes of patients receiving oral anticoagulant (OAC) therapy who require urgent (unplanned) surgery. While limited available evidence suggests high rates of thromboembolism, bleeding and death in this setting, substantial knowledge gaps remain. Aims: We aimed to (i) determine the incidence of adverse events (thrombosis, bleeding, death) among OAC-treated patients requiring urgent surgery, (ii) examine management and resource utilization, and (iii) explore factors associated with adverse outcomes. Methods: PAUSE-ER was a prospective observational study conducted at 10 sites (Canada, US, Greece, Argentina). OAC-treated adults requiring OAC interruption for urgent (unplanned) surgery/invasive procedure (within 72 hours)were eligible. Patients undergoing elective (planned), or minimal bleed risk surgeries/procedures not requiring OAC interruption were excluded. Data were collected from medical records and telephone follow-up at 30 days. Results: 242 participants were enrolled (2019–2022). The mean age was 75 years and 50% were female. OAC use comprised apixaban (40%), warfarin (38%), rivaroxaban (16%), edoxaban (1%) and dabigatran (0.4%). The commonest indication for OAC was atrial fibrillation (74%). The most common surgeries were orthopedic (n = 84), general surgery (n = 42), vascular surgery (n = 16), neurosurgery (n = 16), interventional radiology procedures (n = 10), urologic surgery (n = 9), and cardiothoracic surgery (n = 8). Most patients (76%) received general anesthesia and 5% had neuraxial anesthesia. Perioperatively, patients received idarucizumab (n = 1), andexanet-alfa (n = 1), prothrombin complex concentrate (n = 45), plasma (n = 8), vitamin K (n = 61) and tranexamic acid (n = 31). At 30-days follow-up, 12 patients (5%) died, 18 (7%) had bleeding complications and 4 (2%) experienced thromboembolic events (ischemic stroke [n = 3] and pulmonary embolism [n = 1]). Conclusion(s): In the first prospective evaluation of unselected OAC-treated patients requiring urgent surgery, we showed that management was variable and adverse outcome rates appeared higher than those observed after elective (planned) surgery. Further research aims to inform best practices for OAC management to reduce morbidity and mortality. [Figure presented]
Volume
7
