Outcomes of Upper Gastrointestinal Bleeding Are Similar Between Direct Oral Anticoagulants and Vitamin K Antagonists

Claire Gouriou; Guillaume Bouguen; Pierre Lahmek; Agnes Pelaquier; Ramuntxo Arotcarena; Armand Garioud; Stephanie De Montigny-Lenhardt; Arnaud Pauwels; David Zanditenas; Claire Charpignon; Remi Combes; Stephane Nahon; Vincent Quentin

Disclosures

Aliment Pharmacol Ther. 2021;53(6):688-695. 

In This Article

Patients and Methods

From November 2017 to October 2018, 46 French general hospitals participated in a prospective study on the epidemiological characteristics, management and outcome of UGIB. The physician in charge of the patient completed an electronical case report form (e-CRF). Data were then centralised to the national coordinator and fed into a database for statistical analysis. The study was approved by the Committee for the Protection of Persons 'Sud Méditerranée II' with the identification number 2017-A01920-53.

Inclusion Criteria

This study is a subgroup analysis of an observational prospective study. Patients were included if they fulfilled one of the following criteria: haematemesis and/or melaena and/or acute anaemia with blood in the stomach (identified by performing a nasogastric tube or endoscopic examination) occurring before admission or during hospitalisation for another reason. All patients treated with an oral anticoagulant at the time of the UGIB were retrieved from this initial cohort and assessed.

Data Collected

Clinical data included the age, sex, weight, past history of cirrhosis, peptic ulcer or UGIB and medications in the 7 past days. Comorbidities were assessed with the Charlson score. Excessive alcohol consumption was defined as more than three drinks per day (30 g). Biological data included complete blood count, coagulation tests and factor V, urea and creatinin, bilirubin and albumin. Pre-endoscopy data also contained heart rate, arterial pressure, occurrence of shock (defined by systolic blood pressure <100 mm Hg with a heart rate >100 beats/min), need for resuscitation, red blood transfusion or coagulopathy treatment, erythromycin infusion before endoscopy, use of PPIs or somatostatin. Prognosis scores (Rockall and Blatchford) were calculated for each patient, CHILD and MELD when appropriate. Based on previous studies, low-risk patients were defined as those having a pre-endoscopy Rockall score of ≤2.[23] The following endoscopic data were collected: delay after bleeding, anaesthesia, endoscopic findings, haemostatic treatment and Helicobacter pylori status. Post-endoscopic included total number of red blood transfusion, bleeding recurrence, second look endoscopy, prolongation of hospitalisation and its origin and follow-up at 6 weeks. Resumption of the initial treatment (anticoagulants and antiplatelet agents) was indicated on the basis of a 5-day cut-off.

Outcomes

The main outcomes were mortality at 6 weeks, rebleeding during the first 6 weeks (defined by another episode of haematemesis and/or melaena and/or acute anaemia with blood in the stomach or haemodynamic instability occurring after resolution of the initial bleeding) and the need for non-endoscopic treatment (surgery or interventional radiology).

Statistical Analysis

Quantitative variables were expressed as mean [±SD] and in case of categorical data as number and percentage (%). Student's t test for quantitative variables and the chi-squared test or Fisher's exact test for qualitative variables were used in the univariate analyses. For multivariate analysis, a first model was built by including all variables resulting from univariate regressions with a P ≤ 0.20 to maximise the integration of confounding factor. A second model was performed for each outcome by selecting variable according to a backward stepwise selection method and adjusted on baseline difference (cirrhosis and kidney failure) (Table S1). The odds ratio (OR) and 95% confidence interval (CI) were calculated for each independent factor. A two-tailed P < 0.05 was taken to be statistically significant. Statistical analysis was performed using JMP Pro 13.2 software (SAS Institute Inc).

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