Abstract

BackgroundThe peri-procedural management of patients on a direct oral anticoagulant (DOAC) requiring an elective digestive (GI) endoscopic procedure remains uncertain.AimsTo investigate the safety of a standardized peri-procedural DOAC management strategy.MethodsThe Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) cohort study was conducted at 23 clinical centers in North America and Europe. Participants (n=3007) all had atrial fibrillation (AF), were >18 years old, long-term users of Apixaban, Rivaroxaban, or Dabigatran, and scheduled for an elective procedure or surgery; all could adhere to the DOAC interruption protocol. This analysis focuses on the 579 patients undergoing a digestive endoscopic procedure. The DOAC interruption (1–2 days pre-endoscopy) and resumption (1–3 days post-endoscopy) strategy is based on the DOAC molecule, patient renal function, with most GI procedures considered at low-risk for bleeding. Follow-up occurred at 30 days. Outcomes included GI bleeding and thromboembolic events (ischemic stroke, transient ischemic attack, myocardial infarction, systemic embolism, deep vein thrombosis, and pulmonary embolism) and mortality.ResultsOf the 556 patients (72.5 +8.6 yrs; 37.4 % female), 38.9%) were on Apixaban, 36.9% on Rivaroxaban, and 24.3% on Dabigatran; 10.1% were on anti-platelet therapy. The overall CHADS score was 1.7 +1.0. Overall, 525 patients were categorized as having a low risk for bleeding, and 31 were at high-risk. DOAC were stopped 2.0 +0.5 days pre-procedure and restarted 1.9 +1.5 days post-procedure. Overall rates were: all bleeding 4.4% (2.9–6.4), GI bleeding 2.5% (1.4–4.2%), while 0.7% (0.3–1.8%) experienced a thromboembolic event. Additional results are listed in Table 1.ConclusionsPatients with AF undergoing a standardized DOAC therapy interruption management protocol for elective digestive endoscopy experienced low rates of major bleeding and arterial thromboembolism.Variable;Patient cohort N=556High-risk group for bleeding N=31 Low risk group for bleeding N=525* Diagnostic procedure N=430 Therapeutic procedure N=21 Mortality0.5 (0.2; 1.6)0.0 (0.0; 11.0)0.6 (0.2; 1.7)0.5 (0.1; 1.7)0.0 (0.0; 15.5)Thromboembolic event0.7 (0.3; 1.8)0.0 (0.0; 11.0)0.8 (0.3; 2.0)0.9 (0.4; 2.4)0.0 (0.0; 15.5)All Bleeding event4.4 (2.9; 6.4)16.1 (7.1; 32.6)3.7 (2.4; 5.6)3.7 (2.3; 6.0)19.1 (7.7; 40.0)GI Bleed2.5 (1.4; 4.2)9.7 (3.3; 24.9)2.1 (1.2; 3.7)2.1 (1.1; 3.9)4.8 (0.8; 22.7)All results reported as % and 95% CI * outcomes were missing for 4 patients that had the procedureFunding AgenciesNone

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