Abstract Number: PB2054
Meeting: ISTH 2020 Congress
Theme: Venous Thromboembolism and Cardioembolism » Atrial Fibrillation
Background: In the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, patients taking a direct oral anticoagulant (DOAC) for atrial fibrillation (AF) followed a simple, standardized perioperative management strategy prior to an elective surgery/procedure.
Aims: To analyze how patient and surgery characteristics affect clinical outcomes.
Methods: We categorized patients based on 3 pre-surgical variables: (i) surgical bleed risk (high vs. low); (ii) DOAC dose, and (iii) patient renal function (creatinine clearance [CrCl] < 50 or ≥50 mL/min). Clinical outcomes analyzed included major bleeding (MB), arterial thromboembolism, any bleeding (composite of MB and clinically-relevant non-major bleeding (CRNMB)), and any thromboembolism (TE) (composite of arterial and venous 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 AF requiring perioperative DOAC management. The most important pre-surgical variable was surgical bleed risk where the rate of MB was higher after high bleeding risk procedures (Table 1). The excess bleeding occurred despite a doubling in the duration of DOAC interruption before and an additional 24-48-hour delay in DOAC resumption after high risk procedures. Surgical bleeding risk did not influence the risk of TE outcomes (Table 2). There were no significant differences in bleeding or TE outcomes when comparing DOAC dose and patient renal function (p=NS for apixaban, dabigatran, rivaroxaban, data not shown).
Conclusions: Our results suggest that surgical bleed risk is an important determinant of bleeding but not thromboembolic outcomes. DOAC dose and renal function appeared to have no effect on these outcomes. Further study is needed to investigate independent determinants of bleeding and thromboembolism in patients who need to interrupt DOAC therapy for an elective surgery/procedure.
| DOAC Cohort and Surgical Bleed Risk | ||||||
| Apixaban | Dabigatran Etexilate | Rivaroxaban | ||||
| Outcome | High bleed-risk (n=406) | Low bleed risk (n=851) | High bleed-risk (n=228) | Low bleed-risk (n=440) | High bleed-risk (n=373) | Low bleed-risk (n=709) |
| Major Bleeding | ||||||
| n, % (95% CI) | 12, 2.96 (1.7-5.09) | 5, 0.59 (0.25-1.37) | 2, 0.88 (0.24-3.14) | 4, 0.91 (0.35-2.31) | 11, 2.95 (1.65-5.2) | 9, 1.27 (0.67-2.39) |
| P-value | P=0.001 | P=1.000 | P=0.059 | |||
| Any bleed (MB+CRNB) | ||||||
| n, % (95% CI) | 23, 5.67 (3.8-8.36) | 15, 1.76 (1.07-2.89) | 7, 3.07 (1.4-6.2) | 12, 2.73 (1.57-4.71) | 25, 6.70 (4.58-9.71) | 20, 2.82 (1.83-4.32) |
| P-value | P<0.001 | P=0.809 | P=0.004 | |||
[Table 1. Effect of Surgical Bleed Risk on Major Bleeding and Any Bleeding]
| DOAC Cohort and Surgical Bleed Risk | ||||||
| Apixaban | Dabigatran Etexilate | Rivaroxaban | ||||
| Outcome | High bleed-risk (n=406) | Low bleed risk (n=851) | High bleed-risk (n=228) | Low bleed-risk (n=440) | High bleed-risk (n=373) | Low bleed-risk (n=709) |
| Arterial Thromboembolism | ||||||
| n, % (95%CI) | 1, 0.25 (0.04-1.38) | 1, 0.12 (0.02-0.66) | 1, 0.44 (0.08-2.44) | 3, 0.68 (0.23-1.99) | 2, 0.54 (0.15-1.93) | 2, 0.28 (0.08-1.02) |
| P-value | P=0.542 | P=1.000 | P=0.612 | |||
| Any TE | ||||||
| n, % (95% CI) | 7, 1.72 (0.84-3.52) | 2, 0.24 (0.06-0.85) | 3, 1.32 (0.45-3.8) | 4, 0.91 (0.35- 2.31) | 3, 0.80 (0.27-2.34) | 2, 0.28 (0.08-1.02) |
| P-value | P=0.007 | P=0.695 | P=0.347 | |||
[Table 2. Effect of Surgical Bleed Risk on Arterial Thromboembolism and Any Thromboembolism]
To cite this abstract in AMA style:
MacDougall K, Douketis J, Li N, Clark N, Tafur A, D'Astous J, Duncan J, Schulman S, Spyropoulos A. Effect of Patient and Surgery Characteristics on Clinical Outcomes in the Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) Study [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/effect-of-patient-and-surgery-characteristics-on-clinical-outcomes-in-the-perioperative-anticoagulation-use-for-surgery-evaluation-pause-study/. Accessed September 21, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/effect-of-patient-and-surgery-characteristics-on-clinical-outcomes-in-the-perioperative-anticoagulation-use-for-surgery-evaluation-pause-study/