Abstract
With the increase in prevalence of cardiovascular diseases, multimorbidity, and medical progress, oral antithrombotic (AT) combinations are increasingly prescribed. The aims of this study were to estimate the incidence of oral AT combinations, their appropriateness (defined as indications compliant with guidelines), and the related risk of major bleeding (i.e., leading to hospitalization) or death, among new users. We conducted a 5-year historical cohort study, using the French national healthcare database, including all individuals ≥ 45 years old with a first delivery of oral ATs between 1 January 2013 and 31 December 2017. The cumulative incidence of oral AT combinations was estimated with the Fine and Gray method, taking into account the competitive risk of death. We compared the cumulative incidence of major bleeding according to the type of oral AT treatment initiated at study entry (monotherapy or oral AT combinations). During the study period, 22,220 individuals were included (mean (SD) age 68 (12) years). The cumulative incidence of oral AT combinations at 5 years was 27.8% (95% confidence interval (CI) 26.8–28.9). Overall, 64% of any oral AT combinations did not comply with guidelines. The cumulative incidence of major bleeding and death in the whole cohort at 5 years was 4.1% (95% CI 3.7–4.6) and 10.8% (95% CI 10.1–11.6), respectively. Risk of major bleeding increased among individuals with oral AT combinations versus oral AT monotherapy at study entry (subdistribution hazard ratio sHR: 2.16 (1.01–4.63)); with no difference in terms of death. The use of oral AT combinations among oral AT users is frequent, often inappropriately prescribed, and associated with an increased risk of major bleeding.
Highlights
We conducted a 5-year historical cohort study using data from the Échantillon Généraliste des Bénéficiaires (EGB), a dynamic random permanent sample (1/97th) from the Système National des Données de Santé (SNDS, French national health care database) that includes all individuals affiliated with the French health insurance system since 2005 [11]
Event of interest: hospitalization for major bleeding, n = 86; Event in competition: death = n = 167; a Reference group is oral AT monotherapy; b Reference: 45–64 years old; Abbreviations: subdistribution HR (sHR): subdistribution hazard ratio; 95% CI: 95% confidence interval
$ Event of interest: death, n = 167; a Reference group is oral AT monotherapy; b Reference group: 45–64 years old; Abbreviations: AT: antithrombotics; HR: hazard ratio; 95% CI: 95% confidence interval
Summary
Antithrombotics (ATs) (i.e., antiplatelet and anticoagulant therapies) are the most frequent drug class implicated in serious and fatal adverse drug events (ADEs) [1,2]. Oral AT combinations greatly increase this risk (mainly bleeding), especially when oral anticoagulation is combined with oral antiplatelet agents [3,4]. ADEs may result from medication errors that could be prevented or from adverse drug reactions not related to medication errors [5]. Avoidable [5,6], and due to treatment misusage [7] which mainly occurs at the stage of prescribing [5]. With the increase in prevalence of cardiovascular diseases, multimorbidity and medical progress [8], oral AT combinations are increasingly prescribed. In a recent European prospective cohort study of patients with non-valvular atrial fibrillation (NV-AF) [9], 95.3%
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