Perioperative Management of Direct Oral Anticoagulants in Urological Surgery: The Prospective PAUSE-URO Study.

BACKGROUND AND OBJECTIVE: 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. METHODS: 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. KEY FINDINGS AND LIMITATIONS: 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. CONCLUSION AND CLINICAL IMPLICATIONS: 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.