Endoscopy 2015; 47(11): 997-1004
DOI: 10.1055/s-0034-1392408
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Bleeding after endoscopic sphincterotomy or papillary balloon dilation among users of antithrombotic agents

Tsuyoshi Hamada
1   Department of Gastroenterology, 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
,
Yousuke Nakai
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
,
Hiroyuki Isayama
1   Department of Gastroenterology, 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
,
Hiromasa Horiguchi
3   Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters, Tokyo, Japan
,
Kiyohide Fushimi
4   Department of Health Care Informatics, Tokyo Medical and Dental University, Tokyo, Japan
,
Kazuhiko Koike
1   Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
› Author Affiliations
Further Information

Publication History

submitted 17 December 2014

accepted after revision 29 April 2015

Publication Date:
30 June 2015 (online)

Background and study aims: Severe bleeding is a potentially lethal complication after endoscopic sphincterotomy (EST) and endoscopic papillary balloon dilation (EPBD) for choledocholithiasis. This study aimed to evaluate the impact of antiplatelet agents and anticoagulants on this complication.

Patients and methods: Patients who underwent EST and EPBD were identified in a Japanese nationwide administrative database covering 1090 hospitals. Adjusting for other potential risk factors, we evaluated the association between oral administration of antiplatelet agents and/or anticoagulants (continuation, discontinuation, and non-use) and clinically significant bleeding within 3 days of the procedure.

Results: In total, 61 002 patients were analyzed (EST, 54 493 patients; EPBD, 6509). The rate of severe bleeding was 0.8 % in both groups, but EPBD was performed more frequently than EST in patients with chronic renal failure, liver cirrhosis, and in those receiving antiplatelet agents or anticoagulants. The impact of continuation/discontinuation of antiplatelet agents on severe bleeding was not statistically significant in the EST or EPBD groups. The use of anticoagulants was associated with a statistically significant increase in severe bleeding compared with non-use for EST (1.6 % 27 of 1688 patients vs. 0.8 % 429 of 52 805 patients; adjusted odds ratio [OR] 1.70; 95 % confidence interval [CI] 1.10 – 2.63) and for EPBD (3.0 % [8 of 263 patients] vs. 0.7 % 46 of 6246 patients; adjusted OR 2.91; 95 %CI 1.36 – 6.24).

Conclusions: EST and EPBD can be safely performed in patients receiving antiplatelet agents. Users of anticoagulants are at high risk of bleeding, and the periprocedural management of these should be further investigated.

 
  • References

  • 1 Buxbaum J. Modern management of common bile duct stones. Gastrointest Endosc Clin N Am 2013; 23: 251-275
  • 2 Vaira D, D'Anna L, Ainley C et al. Endoscopic sphincterotomy in 1000 consecutive patients. Lancet 1989; 2: 431-434
  • 3 Freeman ML, Nelson DB, Sherman S et al. Complications of endoscopic biliary sphincterotomy. NEJM 1996; 335: 909-918
  • 4 Mathuna PM, White P, Clarke E et al. Endoscopic balloon sphincteroplasty (papillary dilation) for bile duct stones: efficacy, safety, and follow-up in 100 patients. Gastrointest Endosc 1995; 42: 468-474
  • 5 Tsujino T, Kawabe T, Komatsu Y et al. Endoscopic papillary balloon dilation for bile duct stone: immediate and long-term outcomes in 1000 patients. Clin Gastroenterol Hepatol 2007; 5: 130-137
  • 6 Cotton P, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
  • 7 Nelson DB, Freeman ML. Major hemorrhage from endoscopic sphincterotomy: risk factor analysis. J Clin Gastroenterol 1994; 19: 283-287
  • 8 Lambert ME, Betts CD, Hill J et al. Endoscopic sphincterotomy: the whole truth. Br J Surg 1991; 78: 473-476
  • 9 Bergman JJ, Rauws EA, Fockens P et al. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bile duct stones. Lancet 1997; 349: 1124-1129
  • 10 Fujita N, Maguchi H, Komatsu Y et al. Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial. Gastrointest Endosc 2003; 57: 151-155
  • 11 Disario JA, Freeman ML, Bjorkman DJ et al. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology 2004; 127: 1291-1299
  • 12 Baigent C, Blackwell L et al. Antithrombotic Trialists Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009; 373: 1849-1860
  • 13 Diener HC, Cunha L, Forbes C et al. European Stroke Prevention Study. 2. Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke. J Neurol Sci Turk 1996; 143: 1-13
  • 14 Hussain N, Alsulaiman R, Burtin P et al. The safety of endoscopic sphincterotomy in patients receiving antiplatelet agents: a case-control study. Aliment Pharmacol Ther 2007; 25: 579-584
  • 15 Onal IK, Parlak E, Akdogan M et al. Do aspirin and non-steroidal anti-inflammatory drugs increase the risk of post-sphincterotomy hemorrhage – a case-control study. Clin Res Hepatol Gastroenterol 2013; 37: 171-176
  • 16 Abdel SamieAA, Sun R, Vohringer U et al. Safety of endoscopic sphincterotomy in patients under dual antiplatelet therapy. Hepatogastroenterology 2013; 60: 659-661
  • 17 Hui CK, Lai KC, Yuen MF et al. Does withholding aspirin for one week reduce the risk of post-sphincterotomy bleeding?. Aliment Pharmacol Ther 2002; 16: 929-936
  • 18 Park DH, Kim MH, Lee SK et al. Endoscopic sphincterotomy vs. endoscopic papillary balloon dilation for choledocholithiasis in patients with liver cirrhosis and coagulopathy. Gastrointest Endosc 2004; 60: 180-185
  • 19 Ito Y, Tsujino T, Togawa O et al. Endoscopic papillary balloon dilation for the management of bile duct stones in patients 85 years of age and older. Gastrointest Endosc 2008; 68: 477-482
  • 20 Committee ASoP, Anderson MA, Ben-Menachem T et al. Management of antithrombotic agents for endoscopic procedures. Gastrointest Endosc 2009; 70: 1060-1070
  • 21 Boustiere C, Veitch A, Vanbiervliet G et al. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2011; 43: 445-461
  • 22 Yasunaga H, Hashimoto H, Horiguchi H et al. Variation in cancer surgical outcomes associated with physician and nurse staffing: a retrospective observational study using the Japanese Diagnosis Procedure Combination Database. BMC Health Serv Res 2012; 12: 129
  • 23 Ogoshi K, Kaneko E, Tada M et al. Japan Gastroenterological Endoscopy Society Risk Management Committee. Use of anticoagulants and antiplatelet agents during endoscopic procedures. Gastroenterol Endosc 2005; 47: 2691-2695 (in Japanese)
  • 24 Baron TH, Kamath PS, McBane RD. Management of antithrombotic therapy in patients undergoing invasive procedures. NEJM 2013; 368: 2113-2124
  • 25 Zhao HC, He L, Zhou DC et al. Meta-analysis comparison of endoscopic papillary balloon dilatation and endoscopic sphincteropapillotomy. World J Gastroenterol 2013; 19: 3883-3891
  • 26 Kawabe T, Komatsu Y, Tada M et al. Endoscopic papillary balloon dilation in cirrhotic patients: removal of common bile duct stones without sphincterotomy. Endoscopy 1996; 28: 694-698
  • 27 Sasahira N, Tada M, Yoshida H et al. Extrahepatic biliary obstruction after percutaneous tumour ablation for hepatocellular carcinoma: aetiology and successful treatment with endoscopic papillary balloon dilatation. Gut 2005; 54: 698-702
  • 28 Sung JJ, Lau JY, Ching JY et al. Continuation of low-dose aspirin therapy in peptic ulcer bleeding: a randomized trial. Ann Int Med 2010; 152: 1-9
  • 29 Derogar M, Sandblom G, Lundell L et al. Discontinuation of low-dose aspirin therapy after peptic ulcer bleeding increases risk of death and acute cardiovascular events. Clin Gastroenterol Hepatol 2013; 11: 38-42
  • 30 Desai J, Granger CB, Weitz JI et al. Novel oral anticoagulants in gastroenterology practice. Gastrointest Endosc 2013; 78: 227-239
  • 31 Baron TH, Kamath PS, McBane RD. New anticoagulant and antiplatelet agents: a primer for the gastroenterologist. Clin Gastroenterol Hepatol 2014; 12: 187-195
  • 32 Eknoyan G, Wacksman SJ, Glueck HI et al. Platelet function in renal failure. NEJM 1969; 280: 677-681
  • 33 Amitrano L, Guardascione MA, Brancaccio V et al. Coagulation disorders in liver disease. Semin Liv Dis 2002; 22: 83-96
  • 34 Takahara N, Isayama H, Sasaki T et al. Endoscopic papillary balloon dilation for bile duct stones in patients on hemodialysis. J Gastroenterol 2012; 47: 918-923