Effect of Direct Oral Anticoagulant, Patient, and Surgery Characteristics on Clinical Outcomes in the Perioperative Anticoagulation Use for Surgery Evaluation Study

Abstract

Introduction The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) Study assessed a standardized perioperative management strategy in patients with atrial fibrillation who were taking a direct oral anticoagulant (DOAC) and required an elective surgery or procedure. The aim of this substudy is to analyze the safety of this management strategy across different patient subgroups, according to four presurgical variables: (1) DOAC type and dose, (2) surgery/procedure bleed risk, (3) patient renal function, and (4) age. Methods Clinical outcomes analyzed included major bleeding (MB), arterial thromboembolism, any bleeding, and any thromboembolism. We used descriptive statistics to summarize clinical outcomes, where the frequency, proportion, and 95% confidence interval were reported. Fisher's exact tests were used for testing the null hypothesis of independence between the clinical outcome and patient characteristic, where the test p-values were reported. Results There were 3,007 patients with atrial fibrillation requiring perioperative DOAC management. There was no significant difference in bleeding or thromboembolic outcomes according to DOAC type/dose regimen, renal function, or patient age. The rate of MB was significantly higher with high bleed risk procedures than low bleed risk procedures in apixaban-treated patients (2.9 vs. 0.59%; p < 0.01), but not in dabigatran-treated patients (0.88 vs. 0.91%; p = 1.0) or rivaroxaban-treated patients (2.9 vs. 1.3%; p = 0.06). The risk for thromboembolism did not differ according to surgery/procedure-related bleed risk. Conclusion Our results suggest that in DOAC-treated patients who received standardized perioperative management, surgical bleed risk is an important determinant of bleeding but not thromboembolic outcomes, although this finding was not consistent across all DOACs. There were no differences in bleeding and thromboembolism according to DOAC type and dose, renal function, or age.

Coagulation Tests and Reversal Agents in Patients Treated with Oral Anticoagulants: The Challenging Scenarios of Life-Threatening Bleeding and Unplanned Invasive Procedures

“…In patients requiring high-bleed-risk procedures (i.e., cardiac, intracranial, aortic aneurysm surgery), the rate of the bleeding events was significantly higher than in patients undergoing low-bleed-risk procedures (pacemaker implantation, tooth extraction) in patients on apixaban (2.9 vs. 0.59%; p< 0.01); no difference was found in patients treated with dabigatran or rivaroxaban. The bleeding risk related to the procedure did not influence the risk of thromboembolism [76].…”

Anticoagulation Stewardship to Bridge the Implementation Gap in Perioperative Anticoagulation Management

“…Moreover, risk factors for perioperative bleeding or thrombotic complications are also prevalent including: cancer, anemia, thrombocytopenia, bleeding history, or extensive surgery 1,7,8 . Thus, even in carefully planned clinical trials focused on minimizing adverse events, major bleeding occurs in ~2-3% of patients, most often in the first 10 perioperative days 4,9,10 .…”

“… 1 7 8 Thus, even in carefully planned clinical trials focused on minimizing adverse events, major bleeding occurs in approximately 2 to 3% of patients, most often in the first 10 perioperative days. 4 9 10 …”

“…1,7,8 Thus, even in carefully planned clinical trials focused on minimizing adverse events, major bleeding occurs in approximately 2 to 3% of patients, most often in the first 10 perioperative days. 4,9,10 To guide safe perioperative management of patients taking antithrombotic agents, the American College of Chest Physicians (ACCP) updated their Perioperative Antithrombotic Management guidelines in 2022 and considered 43 patient-intervention-comparator-outcome questions relating to perioperative anticoagulation care. 11 Unfortunately, there still remain gaps in guideline implementation in health care, 12 including in the application of guidelines for patients who need perioperative anticoagulation care.…”