Endoscopy and Antiplatelet Agents: European Society Of
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Guidelines 445 Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) Guideline Authors C. Boustière1, A. Veitch2, G. Vanbiervliet3, P. Bulois4, P. Deprez5, A. Laquiere1, R. Laugier6, G. Lesur7, P. Mosler8, B. Nalet9, B. Napoleon10, B. Rembacken11, N. Ajzenberg12, J. P. Collet13, T. Baron14, J.-M. Dumonceau15 Institutions Institutions are listed at the end of article. submitted With the increasing use of antiplatelet agents stopped. New data allow better assessment of 15 December 2010 (APA), their management during the periendo- these risks, of the necessary duration of APA dis- accepted after revision scopic period has become a more common and continuation before endoscopy, of the use of alter- 21 December 2010 more difficult problem. The increase in use is native procedures (mostly for endoscopic retro- Bibliography due to the availability of new drugs and the wide- grade cholangiopancreatography [ERCP]), and of DOI http://dx.doi.org/ spread use of drug-eluting coronary stents. Acute endoscopic methods that can be used to prevent 10.1055/s-0030-1256317 coronary syndromes can occur when APA therapy bleeding (following colonic polypectomy). This Endoscopy 2011; 43: is withheld for noncardiovascular interventions. guideline makes graded, evidence-based, recom- 445–458 © Georg Thieme Guidelines about APA management during the mendations for the management of APA for all Verlag KG Stuttgart · New York ISSN 0013-726X periendoscopic period are traditionally based on currently performed endoscopic procedures. A assessments of the procedure-related risk of short summary and two Tables are included for Corresponding author bleeding and the risk of thrombosis if APA are quick reference. J.-M. Dumonceau, MD, PhD Service of Gastroenterology and 1. Introduction In this Guideline, the current evidence is re- Hepatology Geneva University Hospitals ! viewed and recommendations made for the man- Rue Gabrielle-Perret Gentil 4 Antiplatelet agents (APA) reduce the aggregation agement of APA therapy in patients undergoing 1211 Genève 14 of platelets and are commonly used in patients endoscopic procedures. Switzerland with coronary heart disease, peripheral arterio- Fax: +41-22-3729366 pathy, and cardiac arrhythmias. Coronary heart [email protected] disease represents the most frequent indication 2. Methods because there is a risk of coronary stent occlusion ! which requires continuous treatment with APA. The European Society of Gastrointestinal Endos- The risk of stent occlusion is most important in copy (ESGE) commissioned and funded this the immediate post-stent placement period. Guideline, which was based on preparatory work There are varying levels of thrombotic risk de- performed by the French Society of Digestive pending on the type of stent placed (bare or Endoscopy. The process was similar to that used drug-eluting stent) as well as other risk factors in creating other ESGE guidelines [4]. It included [1]. Conditions that require APA therapy as well face-to-face meetings, teleconferences, and elec- as the modalities of APA administration have re- tronic-based discussions among subgroups and cently been updated in guidelines issued by the members of the entire committee during 2010. European Society of Cardiology and the European Subgroups were formed, each of which was Association for Cardio-Thoracic Surgery [2]. charged with a series of clearly defined key ques- The discontinuation of APA therapy in patients tions (see Appendix e1, available online). The undergoing a noncardiovascular intervention ac- committee chair worked with subgroup leaders counts for approximately 5% of hospitalizations to identify pertinent search terms (see Appendix for acute coronary syndrome. Therefore, perien- e2, available online). Searches of Medline (via doscopic management of patients with a high Pubmed), the Cochrane Library, Embase, and the thrombotic risk if APA is stopped requires knowl- internet were performed. Articles were first selec- edge of both the bleeding risk associated with ted by title; their relevance was then confirmed endoscopic procedures and the potential risks by review of the corresponding abstract. Publica- associated with discontinuation of APA therapy tions with content that was considered irrelevant [3]. were excluded. Additional articles were identified Boustière C et al. ESGE Guideline: Endoscopy and antiplatelet agents … Endoscopy 2011; 43: 445 –458 446 Guidelines quent Guideline version and again discussed using electronic Table 1 Definitions of categories for evidence levels and recommendation mail. Literature searches were repeated in October 2010. Studies grades used in this Guideline [5]. that were published after this date were not considered for inclu- Evidence level sion. This time-point should be the starting point for literature 1+ High quality meta-analyses, systematic reviews of RCTs, or RCTs + with a very low risk of bias searches when this Guideline is updated. 1+ Well conducted meta-analyses, systematic reviews of RCTs, or The manuscript was edited for style by the corresponding author, RCTs with a low risk of bias with approval by subgroup leaders and then by all members of 1– Meta-analyses, systematic reviews, or RCTs with a high risk of bias the Guideline development group. In November 2010 the final 2+ High quality systematic reviews of case–control or cohort draft was sent to all individual ESGE members. After incorpora- + studies; high quality case–control studies tion of comments made by the individual ESGE members, the or cohort studies with a very low risk of confounding, bias, or ESGE Governing Board endorsed the manuscript. It was sent to chance, and a high probability that the relationship is causal the Editorial Board of the journal Endoscopy. It underwent inter- 2+ Well conducted case–control or cohort studies with a low risk of national peer review and all members of the Guideline develop- confounding, bias, or chance, and a moderate probability that the relationship is causal ment group approved the final version. 2– Case–control or cohort studies with a high risk of confounding, Evidence statements and recommendations are stated in italics; bias, or chance and a significant risk that the relationship is not key evidence statements and recommendations are in bold. This causal Guideline was issued in 2011 and will be considered for review in 3 Nonanalytic studies, e.g. case reports, case series 2014, or sooner if substantially different evidence becomes avail- 4 Expert opinion able. Any updates to the Guideline in the interim period will be Recommendation grades noted on the ESGE website: http://www.esge.com/esge-guide- A At least one meta-analysis, systematic review, or RCTrated as 1++ lines.html. and directly applicable to the target population or a systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+ directly applicable to the target population and demonstrating 3. Summary of statements and recommendations overall consistency of results ! B A body of evidence including studies rated as 2++ directly applic- Antiplatelet agents able to the target population and demonstrating overall consis- Low doses of aspirin and thienopyridines (clopidogrel and pra- tency of results sugrel) irreversibly inhibit platelet aggregation. The minimal or extrapolated evidence from studies rated as 1++ or 1+ durations of APA discontinuation that allow for restoration of C A body of evidence including studies rated as 2+ directly applic- normal platelet aggregability are 5 days for aspirin/clopidogrel able to the target population and demonstrating overall consis- and 7 days for prasugrel. tency of results or extrapolated evidence from studies rated as 2++ APA management during the periendoscopic period balances the D Evidence level 3 or 4 or extrapolated evidence from studies rated estimated risk of bleeding associated with the intended procedure as 2+ and the risk of a thrombotic event when APA are withheld. The risks RCT, randomized controlled trial. of bleeding associated with the most commonly performed endo- scopic procedures are discussed in the following paragraphs. A by manually searching the reference lists of retrieved papers. A summary of general and specific recommendations for the man- central repository of selected literature was made available to all agement of APA therapy during the periendoscopic period is pre- members of the guideline development group. Evidence tables sented in●" Table 2 and 3. were generated for each key question based on meta-analyses or randomized controlled trials (RCTs) if these were available; Standard diagnostic endoscopy with or without otherwise, case–control studies, retrospective analyses, and case performance of mucosal biopsy series were included. The number of articles retrieved and select- Esophagogastroduodenoscopy (EGD), colonoscopy, push enterosco- ed for each task force is indicated in the Evidence table (see Ap- py and endoscopic ultrasonography (EUS) without fine-needle as- pendix e3, available online). piration (FNA) present a minimal bleeding risk (Evidence level 2++). For important outcomes, articles were individually assessed by Mucosal biopsy sampling at any digestive site is associated with a using the Method for Evaluating Research and Guideline Evi- very low bleeding risk that is not increased in patients taking APA dence (MERGE) checklists as amended by the Scottish Intercol- (aspirin or clopidogrel) (Evidence level 2+). Prasugrel is likely to legiate Guidelines Network