Journal Article

DKFZ-2026-02211

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Perioperative Management of Direct Oral Anticoagulants in Urological Surgery: The Prospective PAUSE-URO Study.

Carl, N. ; Halber, E. ; Dempfle, C.-E. ; Loeschner, D. ; Wies, C. ; Duerschmied, D. ; Schoettler, J. J. ; Beck, G. ; Mangold, M. H.DKFZ* ; Studier-Fischer, A.DKFZ* ; Waldbillig, F. ; Rassweiler-Seyfried, M.-C. ; Wessels, F. ; Westhoff, N. ; Worst, T. S. ; Honeck, P. ; Michel, M. S. ; Kowalewski, K.-F. (Last author)DKFZ*

2026
Elsevier Amsterdam

Abstract: The perioperative management of patients receiving direct oral anticoagulants (DOACs) who require interruption of anticoagulation for elective urological surgery is a common clinical scenario but is poorly standardized. The primary aim of this study is to evaluate the safety of the novel perioperative PAUSE-URO protocol.The prospective, single-arm observational study, PAUSE-URO, enrolled 480 consecutive patients undergoing elective urological surgery at the Department of Urology, University Medical Center Mannheim, from 2023 to 2025. DOACs were paused for 2 or 4 d preoperatively and resumed on postoperative day 1 at a reduced dose for another 10 d. The primary end point was defined as clinically relevant urological bleeding events, with a safety threshold rate of 8%. Secondary end points included major bleeding, thromboembolic events, and mortality.In the modified intention-to-treat and per-protocol cohorts, clinically relevant urological bleeding occurred in 4.3% (20/468; 95% confidence interval [CI] = 2.6-6.5%; p = 0.002) and 4.5% (18/399; 95% CI = 2.7-7.0%; p = 0.007) of the patients, respectively, with both rates below the predefined safety threshold. Major bleeding events occurred in <1% of the cases, suggesting the feasibility of the PAUSE-URO protocol. There were no deaths, strokes, or systemic embolic events. Peripheral venous thromboembolism occurred in one of the 468 (0.2%) patients and acute coronary syndrome in one of the 468 (0.2%) patients.The PAUSE-URO protocol met the predefined safety threshold in the overall study population, supporting feasibility and informing future randomized investigation. Procedure-specific variation, particularly after endourological procedures, should be considered when applying the protocol in routine urological care.

Keyword(s): Anticoagulants ; Perioperative management ; Urological surgery

Note: #LA:E140# / epub

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Contributing Institute(s):

1. NWG-KKE Intelligente Systeme und Robotik in der Urologie (E140 ; E140)

Research Program(s):

1. 315 - Bildgebung und Radioonkologie (POF4-315) (POF4-315)

Appears in the scientific report 2026

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Database coverage:
; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Essential Science Indicators ; IF >= 5 ; JCR ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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