Major bleeding with antithrombotic agents: a 2012–2015 study using the French nationwide Health Insurance database linked to emergency department records within five areas – rationale and design of SACHA study

Abstract

Bleeding represents the most recognized and feared complications of antithrombotic drugs including oral anticoagulants. Previous studies showed inconsistent results on the safety profile. Among explanations, bleeding definition could vary and classification bias exists related to the lack of medical evaluation. To quantify the risk of major haemorrhagic event and event‐free survival associated with antithrombotic drugs (vitamin K antagonist [VKA], non‐VKA anticoagulant [NOAC], antiplatelet agent, parenteral anticoagulant) in 2012–2015, we linked the French nationwide Health Insurance database (SNIIRAM) with a local ‘emergency database’ (clinical and biological data collected in clinical records). In the VKA‐NOAC comparison, a Cox regression analysis will be used to estimate the hazard ratio of major haemorrhagic event adjusted on gender, modified HAS‐BLED score and comorbidities. A distinction on the type of major haemorrhagic event (intracranial, gastrointestinal and other haemorrhagic events) was made. We present here the study protocol and the database linkage results. Using six linkage keys, among 3 837 557 hospital visits identified in SNIIRAM, 5264 have been matched with a major haemorrhagic event identified in the ‘emergency database’, thus clinically confirmed. The 1090 unmatched haemorrhagic events could be explained by the fact that patients were not extracted in the SNIIRAM database (patients living in accommodation establishment with internal use of pharmacy, military people with specific insurance…). We showed the value of SNIIRAM enrichment with a clinical database, a necessary step to categorize haemorrhagic events by a clinically relevant definition and medical validation; it will allow to estimate more accuracy each type of haemorrhagic event.

Major bleeding risk and mortality associated with antiplatelet drugs in real-world clinical practice. A prospective cohort study

“…The study design has previously been reported [ 18 ]. Briefly, a prospective population-based cohort study was set up linking the French Health Insurance Database (SNIIRAM) to data from all emergency departments located within five well-defined areas around five large French cities (Angers, Brest, Grenoble, Nantes and Rennes).…”

Major gastrointestinal bleeding and antithrombotics: Characteristics and management

“…The SACHA study is a French prospective population-based cohort on the incidence and outcome of major bleeding among patients treated with antithrombotics (parenteral or oral anticoagulant, or antiplatelet agent). The detailed methods have already been published[ 11 ].…”

Hospital databases for the identification of adverse drug reactions: A 2‐year multicentre study in 9 French general hospitals

“…In this study, we chose to focus on certain specific ADRs that concerned ICD10 codes related to dermatological effects (L27.0, L51.1, L51.2), anaphylactic shock (T88.2, T88.6), nephropathy (N14.1, N14.2, N17), hepatic impairment (K71), neuropathy (G62.0) and interstitial lung disease (J70.2, J70.3, J70.4), and either the association of ICD10 code K71 with codes Y40 to Y59/T88.7 or the association of code N17 with the same codes (Appendix Table A1). This choice was based on the results of a previous study performed in 2009 in Rennes evaluating queries on various ICD10 codes to the PMSI database to identify serious ADRs 16 and on the existence of another study 17,18 (see Appendix 1).…”

“…What this study adds Table A1). This choice was based on the results of a previous study performed in 2009 in Rennes evaluating queries on various ICD10 codes to the PMSI database to identify serious ADRs 16 and on the existence of another study 17,18 (see Cases were analysed by the RPVC. Drug causality was assessed using the official French method.…”