CC BY-NC-ND 4.0 · Endosc Int Open 2023; 11(01): E52-E59
DOI: 10.1055/a-1981-2946
Original article

Comparison of bleeding following gastrointestinal endoscopic biopsy in patients treated with and without direct oral anticoagulants

Takaaki Konishi
1   Department of Breast and Endocrine Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
2   Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan
,
Sachiko Ono
3   Department of Eat-loss Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Akira Okada
4   Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Hiroki Matsui
2   Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan
,
Masahiko Tanabe
1   Department of Breast and Endocrine Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Yasuyuki Seto
1   Department of Breast and Endocrine Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
5   Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Hideo Yasunaga
2   Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan
› Author Affiliations
Supported by: Ministry of Health, Labour and Welfare (http://dx.doi.org/10.13039/501100003478) 21AA2007
Supported by: Ministry of Education, Culture, Sports, Science and Technology (http://dx.doi.org/10.13039/501100001700) 20H03907,21H03159

Abstract

Background and study aims Despite the widespread use of direct oral anticoagulants (DOACs), the association between DOAC use and complications (e. g., bleeding) following gastrointestinal endoscopic biopsy remains unclear. This study aimed to evaluate complications after biopsy in patients treated with DOACs in Japan, where biopsies would be generally performed without DOAC withdrawal based on guideline recommendations.

Patients and methods Using a Japanese nationwide database, we identified patients taking DOACs who underwent gastrointestinal endoscopic biopsy (n  = 2,769, DOAC group) and those not taking DOACs (n = 129,357, control group) from April 2015 to November 2020. We conducted 1:4 propensity score (PS) matching and overlap PS-weighting analyses with adjustment for background characteristics to compare occurrence of post-procedure hemorrhage and stroke within 1 week after biopsy, and thrombin use on the day of biopsy without a diagnosis of hemorrhage.

Results In total, 578 patients (0.44 %) developed post-procedure hemorrhage, and 13 patients (0.01 %) developed stroke. The DOAC group had more comorbidities than the control group. The PS matching analysis revealed no significant differences in post-procedure hemorrhage (odds ratio, 1.52 [95 % confidential interval, 0.96–2.41]) or stroke (1.00 [0.21–4.71]), whereas the DOAC group received thrombin more often than the control group (1.60 [1.30–1.95]). The results were equivalent in the overlap PS-weighting analysis.

Conclusions The PS analyses showed no significant differences in complications following gastrointestinal endoscopic biopsy between DOAC users and non-users. These results suggest the safety of endoscopic biopsy without DOAC withdrawal although the need for careful hemostasis remains.

Supplementary material



Publication History

Received: 29 April 2022

Accepted after revision: 15 November 2022

Accepted Manuscript online:
17 November 2022

Article published online:
13 January 2023

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Ruff CT, Giugliano RP, Braunwald E. et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: A meta-analysis of randomised trials. Lancet 2014; 383: 955-962
  • 2 López-López JA, Sterne JAC, Thom HHZ. et al. Oral anticoagulants for prevention of stroke in atrial fibrillation: Systematic review, network meta-analysis, and cost effectiveness analysis. BMJ 2017; 359: j5058
  • 3 Heidbuchel H, Verhamme P, Alings M. et al. Updated European Heart Rhythm Association practical guide on the use of non-vitamin-K antagonist anticoagulants in patients with non-valvular atrial fibrillation: Executive summary. Eur Heart J 2017; 38: 2137-2149
  • 4 Stevens SM, Woller SC, Kreuziger LB. et al. Antithrombotic therapy for VTE disease. Chest 2021; 160: e545-e608
  • 5 Gómez-Outes A, Terleira-Fernández AI, Lecumberri R. et al. Direct oral anticoagulants in the treatment of acute venous thromboembolism: A systematic review and meta-analysis. Thromb Res 2014; 134: 774-782
  • 6 Enomoto A, Mano Y, Kawano Y. et al. Comparison of the safety and effectiveness of four direct oral anticoagulants in Japanese patients with nonvalvular atrial fibrillation using real-world data. Biol Pharm Bull 2021; 44: 1294-1302
  • 7 Kirley K, Qato DM, Kornfield R. et al. National trends in oral anticoagulant use in the United States, 2007 to 2011. Circ Cardiovasc Qual Outcomes 2012; 5: 615-621
  • 8 Lutsey PL, Walker RF, MacLehose RF. et al. Direct oral anticoagulants and warfarin for venous thromboembolism treatment: Trends from 2012 to 2017. Res Pract Thromb Haemost 2019; 3: 668-673
  • 9 Radaelli F, Fuccio L, Paggi S. et al. Periendoscopic management of direct oral anticoagulants: A prospective cohort study. Gut 2019; 68: 969-976
  • 10 Douxfils J, Ageno W, Samama CM. et al. Laboratory testing in patients treated with direct oral anticoagulants: A practical guide for clinicians. J Thromb Haemost 2018; 16: 209-219
  • 11 Beyer-Westendorf J, Gelbricht V, Förster K. et al. Peri-interventional management of novel oral anticoagulants in daily care: Results from the prospective Dresden NOAC registry. Eur Heart J 2014; 35: 1888-1896
  • 12 Healey JS, Eikelboom J, Douketis J. et al. Periprocedure bleeding and thromboembolic events with dabigatran compared with warfarin: Results from the randomized evaluation of long-term anticoagulation therapy (RE-LY) randomized trial. Circulation 2012; 126: 343-348
  • 13 Veitch AM, Radaelli F, Alikhan R. et al. Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update. Gut 2021; 70: 1611-1628
  • 14 Ono S, Fujishiro M, Kodashima S. et al. Evaluation of safety of endoscopic biopsy without cessation of antithrombotic agents in Japan. J Gastroenterol 2012; 47: 770-774
  • 15 Yuki T, Ishihara S, Yashima K. et al. Bleeding risk related to upper gastrointestinal endoscopic biopsy in patients receiving antithrombotic therapy: A multicenter prospective observational study. Curr Ther Res Clin Exp 2017; 84: 32-36
  • 16 Kato M, Uedo N, Hokimoto S. et al. Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment: 2017 appendix on anticoagulants including direct oral anticoagulants. Dig Endosc 2018; 30: 433-440
  • 17 Chan FKL, Goh KL, Reddy N. et al. Management of patients on antithrombotic agents undergoing emergency and elective endoscopy: Joint Asian Pacific Association of Gastroenterology (APAGE) and Asian Pacific Society for Digestive Endoscopy (APSDE) practice guidelines. Gut 2018; 67: 405-417
  • 18 Acosta RD, Abraham NS. ASGE Standards of Practice Committee. et al. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc 2016; 83: 3-16
  • 19 Veitch AM, Vanbiervliet G, Gershlick AH. et al. Endoscopy in patients on antiplatelet or anticoagulant therapy, including Direct Oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of gastrointestinal endoscopy (ESGE) guidelines. Gut 2016; 65: 374-389
  • 20 Fujimoto K, Fujishiro M, Kato M. et al. Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. Dig Endosc 2014; 26: 1-14
  • 21 Okada A, Yasunaga H. Prevalence of noncommunicable diseases in Japan using a newly developed administrative claims database covering young, middle-aged, and elderly people. JMA J 2022; 5: 190-198
  • 22 Sato K, Mano T, Niimi Y. et al. The impact of COVID-19 pandemic on the utilization of ambulatory care for patients with chronic neurological diseases in Japan: Evaluation of an administrative claims database. BioSci Trends 2021; 15: 219-230
  • 23 Quan H, Sundararajan V, Halfon P. et al. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care 2005; 43: 1130-1139
  • 24 Webster-Clark M, Huang TY, Hou L. et al. Translating claims-based CHA2DS2-VaSc and HAS-BLED to ICD-10-CM: Impacts of mapping strategies. Pharmacoepidemiol Drug Saf 2020; 29: 409-418
  • 25 Yasunaga H. Introduction to applied statistics—Chapter 1 propensity Score Analysis. Ann Clin Epidemiol 2020; 2: 33-37
  • 26 Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res 2011; 46: 399-424
  • 27 Desai RJ, Franklin JM. Alternative approaches for confounding adjustment in observational studies using weighting based on the propensity score: A primer for practitioners. BMJ 2019; 367: l5657
  • 28 Thomas LE, Li F, Pencina MJ. Overlap weighting: A propensity score method that mimics attributes of a randomized clinical trial. JAMA 2020; 323: 2417-2418
  • 29 Li F, Morgan KL, Zaslavsky AM. Balancing covariates via propensity score weighting. J Am Stat Assoc 2018; 113: 390-400
  • 30 Sakamoto T, Fujiogi M, Ishimaru M. et al. Comparison of postoperative infection after emergency inguinal hernia surgery with enterectomy between mesh repair and non-mesh repair: A national database analysis. Hernia 2022; 26: 217-223
  • 31 Sieg A, Hachmoeller-Eisenbach U, Eisenbach T. Prospective evaluation of complications in outpatient GI endoscopy: A survey among German gastroenterologists. Gastrointest Endosc 2001; 53: 620-627
  • 32 Parra-Blanco A, Kaminaga N, Kojima T. et al. Hemoclipping for postpolypectomy and postbiopsy colonic bleeding. Gastrointest Endosc 2000; 51: 37-41
  • 33 Kato M, Furuta T, Ito T. et al. Results of a national survey of gastrointestinal endoscopy-related incidents in patients on antithrombotic medications [in Japanese]. Gastroenterological Endosc 2017; 59: 1532-1536
  • 34 Lutsey PL, Norby FL, Ensrud KE. et al. Association of anticoagulant therapy with risk of fracture among patients with atrial fibrillation. JAMA Intern Med 2020; 180: 245-253
  • 35 Kurogi R, Nishimura K, Nakai M. et al. Comparing intracerebral hemorrhages associated with direct oral anticoagulants or warfarin. Neurology 2018; 90: e1143-e1149
  • 36 Gage BF, Waterman AD, Shannon W. et al. Validation of clinical classification schemes for predicting stroke: Results from the national registry of atrial fibrillation. JAMA 2001; 285: 2864-2870
  • 37 Lip GYH, Nieuwlaat R, Pisters R. et al. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: The euro Heart Survey on atrial fibrillation. Chest 2010; 137: 263-272
  • 38 Sato C, Hirasawa K, Koh R. et al. Postoperative bleeding in patients on antithrombotic therapy after gastric endoscopic submucosal dissection. World J Gastroenterol 2017; 23: 5557-5566
  • 39 Yano T, Tanabe S, Ishido K. et al. Different clinical characteristics associated with acute bleeding and delayed bleeding after endoscopic submucosal dissection in patients with early gastric cancer. Surg Endosc 2017; 31: 4542-4550
  • 40 Yamana H, Horiguchi H, Fushimi K. et al. Comparison of procedure-based and diagnosis-based identifications of severe sepsis and disseminated intravascular coagulation in administrative data. J Epidemiol 2016; 26: 530-537
  • 41 De Wijkerslooth TR, De Haan MC, Stoop EM. et al. Burden of colonoscopy compared to non-cathartic CT-colonography in a colorectal cancer screening programme: Randomised controlled trial. Gut 2012; 61: 1552-1559
  • 42 Schisterman EF, Cole SR, Platt RW. Overadjustment bias and unnecessary adjustment in epidemiologic studies. Epidemiology 2009; 20: 488-495