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Surgical bleeding risk most important determinant of bleeding outcomes

Presented by
Dr Kira MacDougall, Staten Island University Hospital, USA
ISTH 2020
Results from the PAUSE study showed that neither type nor dose of direct oral anticoagulant (DOAC) influenced bleeding outcomes in AF patients undergoing elective surgery. The procedure itself carries the most evident bleeding risk for the patients [1].

The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study prospectively assessed a standardised perioperative management strategy in 3 cohorts of patients treated with a DOAC (i.e. apixaban, dabigatran, or rivaroxaban) who needed an elective surgery. The aim of the study, presented by Dr Kira MacDougall (Staten Island University Hospital, USA), was to compare rates of major bleeding, arterial thromboembolism, any bleeding (composite of major bleeding and clinically-relevant non-major bleeding), and any thromboembolism (composite of arterial and venous thromboembolism) according to DOAC type and dose, surgery-related bleeding risk, patient´s renal function, and age.

The study included 3,007 patients in 3 cohorts: 41.8% in the apixaban cohort, 22.2% in the dabigatran cohort, and 36% in the rivaroxaban cohort. One-third of all patients underwent a high-bleed-risk surgery. The results suggest that DOAC type does not affect either bleeding or thromboembolism outcomes. Of note, the DOAC dose regimen (apixaban 5 mg vs 2.5 mg, dabigatran 150 mg vs 110 mg, and rivaroxaban 20 mg vs 15 mg) did also not influence the endpoints.

In general, the incidence of major bleeding was low (<2%), but it was higher in patients that underwent a high-bleed-risk surgery. In patients treated with apixaban, the bleeding risk was significantly higher in the high-bleed-risk group compared with the low-bleed-risk group (2.96% vs 0.59%; P=0.001; see Table). This was not the case in dabigatran-treated patients. In the rivaroxaban-treated patients, there was only a numerical difference between the high- and the low-risk group. Further, the rate of arterial thromboembolic events was generally low in all patients, regardless of the risk-group, and neither renal function nor age showed significant differences in bleeding or thromboembolism outcomes.

Table: Bleeding and thromboembolism outcomes for surgical bleeding risk. Adapted from [1]

CI, confidence interval; CRNB, clinically-relevant non-major bleeding; MB, major bleeding.

1          MacDougall K, et al. PB2054, ISTH 2020 Virtual Congress, 12-14 July.


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