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FACTOR XA INHIBITOR–ASSOCIATED GASTROINTESTINAL BLEEDING INCIDENCE AND OUTCOMES IN THE MULTICOUNTRY OBSERVATIONAL AXIOM STUDY

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Introduction

Gastrointestinal bleeds (GIBs) are associated with use of anticoagulants, such as Factor Xa inhibitors (FXai), and may result in significant morbidity and mortality. The goal of this multicountry study was to explore the incidence and burden of GIBs following initial FXai use.

Aims & Methods

This retrospective observational cohort study involved analysis of electronic health records from new users of direct-acting oral anticoagulants (DOACs), specifically FXai, in Germany, the Netherlands, and the UK. Patients with a FXai prescription for a therapeutic indication (eg, venous thromboembolism, atrial fibrillation, non-mechanical cardiac-valve replacement) were included. Incidence rates of GIBs associated with FXai use and mortality after GIB were assessed and reported per 100 person years (PYR) with 95% confidence intervals.

Results

Among new FXai users (Germany, n=78,086; Netherlands, n=17,356; UK, n=212,378), 1583 GIBs were reported in Germany, 205 in the Netherlands, and 4683 in the UK (Table 1). Mean age across countries for patients experiencing a GIB ranged from 75 to 77 years and the proportion of female patients ranged from 42% to 62%. The most common FXai indication among patients with a GIB was atrial fibrillation (85% to 90%). The incidence of GIB at 1 year following FXai initiation was generally consistent across Germany (1.92 per 100 PYR), the Netherlands (1.27 per 100 PYR), and the UK (1.84 per 100 PYR; Table 1). Rates of upper GIBs were higher compared with rates of lower GIBs or unspecified location GIBs in Germany; in the UK and Netherlands, unspecified GIBs occurred at a higher rate than upper or lower GIBs. Rates of all-cause mortality declined from 3 months to 1 year following a GIB for Germany, the Netherlands, and the UK.

Table 1. Incidence of FXai-associated (DOAC only) GIB and All-Cause Mortality after GIB^a

New FXai users	Germany (N=78,086)	Netherlands (N=17,356)	UK (N=212,378)
1-Year incidence of GIB per 100 PYR (95% CI) Overall Lower GIB Upper GIB Unspecified GIB	1.92 (1.80, 2.04) 0.30 (0.26, 0.35) 1.14 (1.05, 1.24) 0.65 (0.58, 0.72)	1.27 (1.07, 1.50) 0.38 (0.27, 0.51) 0.32 (0.23, 0.45) 0.75 (0.60, 0.93)	1.84 (1.77, 1.91) 0.67 (0.63, 0.72) 0.10 (0.08-0.12) 1.06 (1.01, 1.12)
3-Year incidence of GIB per 100 PYR (95% CI) Overall Lower GIB Upper GIB Unspecified GIB	1.51 (1.43, 1.59) 0.22 (0.20, 0.26) 0.92 (0.86, 0.98) 0.49 (0.45, 0.54)	0.98 (0.85, 1.12) 0.30 (0.23, 0.39) 0.29 (0.22, 0.37) 0.51 (0.42, 0.62)	1.55 (1.51, 1.60) 0.56 (0.53, 0.59) 0.09 (0.08, 0.10) 0.90 (0.86, 0.94)
GIB events after FXai use	N=1583	N=162^b	N=4683
All-cause mortality at 3 months after GIB
n (%)	409 (25.8)	6 (3.7)	510 (10.9)
Per 100 PYR (95% CI)	131.2 (118.8, 144.6)	16 (6, 35)	47.5 (43.5, 51.8)
All-cause mortality at 1 year after GIB
n (%)	590 (37.3)	12 (7.4)	914 (19.5)
Per 100 PYR (95% CI)	60.3 (55.5, 65.4)	9.3 (4.8, 16.2)	24.1 (22.6, 25.7)

CI, confidence intervals; CPRD, Clinical Practice Research Datalink; DOAC, direct oral anticoagulant; HES APC, Hospital Episode Statistics Admitted Patient Care; ONS, Office for National Statistics; PYR, person-years.
^aData sources: Germany, WIG2 Claims Database (2016 – 2021); Netherlands, PHARMO Data Network (2008 – 2021); UK, HES APC and ONS data linked to CPRD primary care (2012 – 2020).
^bOf the 205 observed GIBs in the 3 years after FXai initiation, 162 could be followed after the GIB to assess further outcomes such as all-cause mortality.

Conclusion

In this observational study, FXai-associated GIB incidence rates were similar across Germany, the Netherlands, and the UK. Rates of all-cause mortality after a GIB varied between countries and decreased over the first year for all countries.

Disclosure

ATC: consultant for AbbVie, ACI Clinical, Alexion, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Cardinal Health, Centrix, Daiichi-Sankyo, EmstoPA Ltd, Janssen, Johnson & Johnson, Medscape, Sanofi Aventis, and Pfizer.
JL: consulting fees from AstraZeneca, BMS-Pfizer, and Viatris.
RW: reports grants and fees from AstraZeneca, Bayer, and Novartis.
JA: advisor or consultant for BMS-Pfizer, Medtronic, and Amgen; research funding from Carlos III Research Institute, Ministry of Science, Madrid, Spain, Department of Health, Castilla y León regional government, Spain (GRS-SACYL), Aptatargets, and European Commission; researcher for AstraZeneca: speaker for BMS-Pfizer, Medtronic, Boehringer-Ingelheim, and Bayer; and other fees from Daichii-Sankyo.
CIC: grants and consulting fees from AstraZeneca, Bayer, and Janssen.
DCD: no conflicts of interest to report.
EH: employee of the PHARMO Institute for Drug Outcomes Research, an independent research institute that performs financially supported studies for government and related healthcare authorities and several pharmaceutical companies.
EL: no conflicts of interest to report.
AC: advisor for ADIVO Associates LLC, Alexion Pharma Germany, Allergosan GmbH, Biotest AG, Böhringer-Ingelheim International GmbH, CSL-Behring GmbH, CytoSorbents Europe GmbH, Dr. Falk Pharma GmbH, Eisai GmbH, and Elsevie; speaker for Abbvie Deutschland GmbH & Co KG, Academy 2 GmbH & Co. KG, Ardeypharm GmbH, Ärztekammer Nordrhein, Ärztekammer Westfalen-Lippe, BDC e.V., BDI Bundesverband Deutscher Internisten, bng Service GmbH, and CSL.
RZ, JBM, and GG are employees of AstraZeneca.

FACTOR XA INHIBITOR–ASSOCIATED GASTROINTESTINAL BLEEDING INCIDENCE AND OUTCOMES IN THE MULTICOUNTRY OBSERVATIONAL AXIOM STUDY

Alexander Cohen 1, Jenneke Leentjens 2, Robert C. Welsh 3, Juan Arenillas 4, Craig I. Coleman 5, Douglas C. Dover 6, Eline Houben 7, Ruiqi Zhang 8, Jil Billy Mamza 8, George Godfrey 9, Eddy Lang 10, Ali Canbay 11

1 Department of Haematological Medicine, Guys and St. Thomas’ Hospitals NHS Foundation Trust, King’s College, London, United Kingdom

2 Radboud UMC, Nijmegen, Netherlands

3 University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Canada

4 Hospital Clinico Universitario, Valladolid, Spain

5 Department of Pharmacy Practice, University of Connecticut, Storrs, United States

6 Canadian VIGOUR Centre, University of Alberta, Alberta, Canada

7 PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands

8 AstraZeneca, Medical and Scientific Affairs, Biopharmaceuticals Medical, London, United Kingdom

9 AstraZeneca, Biopharmaceuticals Medical, Europe and Canada, Gothenburg, Sweden

10 Cumming School of Medicine, University of Calgary, Calgary, Canada

11 Universitãtsklinikum Knappschaftskrankenhaus Bochum, Bochum, Germany

Event

UEG Week Vienna 2024

Topics

Endoscopy Small Intestine & Nutrition Stomach & H. Pylori Oesophagus

Submission format

Abstract

Session

Upper GI bleeding: Treatment and outcome

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Summary: HCC - all you need to know

Manuel Romero-Gomez 1, Anna Saborowski 2

1 Valme University Hospital University of Seville, Sevilla, Spain

2 Hannover Medical School, Hannover, Germany

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Digestive Oncology Hepatobiliary

Session

Hepatocellular carcinoma: All you need to know

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Standards and Guidelines

Clinical Practice Guideline

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Main recommendations

ESGE recommends that the evaluation of superficial gastrointestinal (GI) lesions should be made by an experienced endoscopist, using high definition white-light and chromoendoscopy (virtual or dye-based).

ESGE does not recommend routine performance of endoscopic ultrasonography (EUS), computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT prior to endoscopic resection.

ESGE recommends endoscopic submucosal dissection (ESD) as the treatment of choice for most superficial esophageal squamous cell and superficial gastric lesions.

For Barrett’s esophagus (BE)-associated lesions, ESGE suggests the use of ESD for lesions suspicious of submucosal invasion (Paris type 0-Is, 0-IIc), for malignant lesions > 20 mm, and for lesions in scarred/fibrotic areas.

ESGE does not recommend routine use of ESD for duodenal or small-bowel lesions.

ESGE suggests that ESD should be considered for en bloc resection of colorectal (but particularly rectal) lesions with suspicion of limited submucosal invasion (demarcated depressed area with irregular surface pattern or a large protruding or bulky component, particularly if the lesions are larger than 20 mm) or for lesions that otherwise cannot be completely removed by snare-based techniques.

ESGE recommends that an en bloc R0 resection of a superficial GI lesion with histology no more advanced than intramucosal cancer (no more than m2 in esophageal squamous cell carcinoma), well to moderately differentiated, with no lymphovascular invasion or ulceration, should be considered a very low risk (curative) resection, and no further staging procedure or treatment is generally recommended.

ESGE recommends that the following should be considered to be a low risk (curative) resection and no further treatment is generally recommended: an en bloc R0 resection of a superficial GI lesion with superficial submucosal invasion (sm1), that is well to moderately differentiated, with no lymphovascular invasion, of size ≤ 20 mm for an esophageal squamous cell carcinoma or ≤ 30 mm for a stomach lesion or of any size for a BE-related or colorectal lesion, and with no lymphovascular invasion, and no budding grade 2 or 3 for colorectal lesions.

ESGE recommends that, after an endoscopically complete resection, if there is a positive horizontal margin or if resection is piecemeal, but there is no submucosal invasion and no other high risk criteria are met, this should be considered a local-risk resection and endoscopic surveillance or re-treatment is recommended rather than surgery or other additional treatment.

ESGE recommends that when there is a diagnosis of lymphovascular invasion, or deeper infiltration than sm1, or positive vertical margins, or undifferentiated tumor, or, for colorectal lesions, budding grade 2 or 3, this should be considered a high risk (noncurative) resection, and complete staging and strong consideration for additional treatments should be considered on an individual basis in a multidisciplinary discussion.

ESGE recommends scheduled endoscopic surveillance with high definition white-light and chromoendoscopy (virtual or dye-based) with biopsies of only the suspicious areas after a curative ESD

Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2022

Pedro Pimentel-Nunes

Publisher

European Society of Gastrointestinal Endoscopy

Guideline

Clinical Practice Guideline

Topics

Endoscopy

Citation

Endoscopy 2022; 54(06): 591-622

Published

2022

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Long-term surveillance and outcome after severe acute pancreatitis

Balint Eross 1

1 Semmelweis University, Budapest, Hungary

Event

UEG Week Berlin 2025

Topics

Pancreas

Session

Acute pancreatitis

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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ACCURACY OF COMPUTER-AIDED DIAGNOSIS IN COLONOSCOPY VARIES ACCORDING TO POLYP LOCATION. A SYSTEMATIC REVIEW AND META-ANALYSIS

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Introduction

Computer-Aided Diagnosis (CADx) is emerging as a tool to assist endoscopists in differentiating neoplastic from non-neoplastic small polyps during colonoscopy. In clinical practice, the application of optical diagnosis strategies, such as ‘’the resect and discard’’ and the ‘’leave-in-situ’’, vary according to the polyp location. This study aimed to evaluate the impact of polyp location (proximal colon vs. distal colon) on the diagnostic performance of CADx systems for small polyps (<5mm) identified during colonoscopy.

Aims & Methods

A comprehensive literature search was conducted in MEDLINE, Scopus, and Embase databases, with the last search performed on March 12, 2024. Studies evaluating the stand-alone performance of real-time CADx for predicting the histology of colorectal polyps ≤5mm in size were included. Studies without pathological confirmation or with fewer than 50 patients were excluded. The primary endpoints were the sensitivity and specificity of the CADx in the proximal and distal colon. Secondary outcomes were the negative predictive value (NPV), positive predictive value (PPV) and accuracy of the CADx alone in the proximal and distal colon. The distal colon comprised the rectum and sigmoid, while the proximal colon comprised the portion extending from the descending colon to the cecum.

Results

We included 11 studies for analysis with a total of 7,782 polyps (<5mm). CADx accuracy was significantly lower in the proximal colon compared to the rectosigmoid in terms of specificity (62% versus 84%; risk ratio (RR): 0.78 [95% confidence interval (CI): 0.72-0.84], I²=47.08%), NPV (64% versus 93%; RR: 0.71 [95% CI: 0.64-0.79], I²=74.69%), and accuracy (81% vs 86%; RR: 0.95 [95% CI: 0.91-0.99], I²=72.50%). On the other hand, sensitivity (87% vs 87%; RR: 1.00 [95% CI: 0.98-1.02], I²=0%) and PPV (87% vs 76%; RR: 1.11 [95% CI: 1.06-1.17], I²=53.85%) were comparable.

Conclusion

The diagnostic performance of CADx appears to depend on the location of the polyp, being substantially lower for proximal than distal lesions, mainly due to a lower specificity in the proximal colon.

Disclosure

Cesare Hassan: Fujifilm Co. (consultancy); Medtronic Co. (consultancy), Yuichi Mori: Olympus Corp (consultancy, speaking honorarium, equipment loan); Cybernet System (ownership interest), Alessandro Repici: Fujifilm Co. (consultancy); Olympus Corp (consultancy); Medtronic Co. (consultancy).

ACCURACY OF COMPUTER-AIDED DIAGNOSIS IN COLONOSCOPY VARIES ACCORDING TO POLYP LOCATION. A SYSTEMATIC REVIEW AND META-ANALYSIS

Tommy Rizkala 1, Cesare Hassan 2, Marco Spadaccini 1, Yuichi Mori 3, Prateek Sharma 4, Douglas Kevin Rex 5, Alessandro Repici 1

1 Humanitas Clinical and Research Center –IRCCS-, Endoscopy Unit, Rozzano, Italy., Milano, Italy

2 Humanitas Clinical and Research Center –IRCCS-, Endoscopy Unit, Rozzano, Italy., Rome, Italy

3 University of Oslo / Showa University, Oslo, Norway

4 University of Kansas School of Medicine Dept. of Gastroenterology, Leawood, United States

5 Indiana University School of Medicine, Division of Gastroenterology, Indianapolis, Indiana, USA, Indiana, United States

Event

UEG Week Vienna 2024

Topics

Colorectal Endoscopy

Submission format

Abstract

Session

Optimising safety and efficacy of polyp treatment

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Endoscopy

Pichamol Jirapinyo 1

1 Brigham and Women's Hospital, Boston, United States of America

Event

UEG Week Berlin 2025

Topics

Digestive Oncology Endoscopy Hepatobiliary Small Intestine & Nutrition

Session

Best of DDW

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

Standard Poster

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Introduction

The global prevalence of Helicobacter pylori (HP) infection is almost 43% and affects almost 18% of Italians [1, 2]. The literature describes several endoscopic signs detectable during upper-GI endoscopy that may predict HP status [3]; however, in clinical practice, random biopsies according to the Sydney system are still widely used for its determination.

Aims & Methods

The aim of our study is to investigate the role of Regular arrangement of collecting venules (RAC) assessment, during upper-GI endoscopies, for predicting HP status. We conducted a monocentric prospective study including patients who underwent upper-GI endoscopy for any indications from August 2024 to February 2025. Upper-GI endoscopies were performed according to standard of care [4], with high-definition scopes and after adequate cleaning [5]. Exclusion criteria were autoimmune gastritis, antibiotics within the previous 4 weeks, gastric surgery, previous endoscopic submucosal resection, upper-GI neoplasms, age <18 years, severe liver/kidney disease and previous known HP infection. Every procedure was performed by 6 endoscopists trained in recognition of all typical endoscopic signs of healthy stomach or HP infection: RAC, fundic gland polyps, linear streaks, hematin spots and diffuse redness prior to data collection. HP infection was investigated by histological evaluation by bioptic sampling, obtained according to the Sydney criteria.

Results

From 429 enrolled patients, 244 patients were included, according to inclusion criteria (M 124, 50.8%, median age 54.9, IQR 41.9-65.0). The prevalence of H. pylori infection was 15.5% (38/244). The presence of RAC in both greater and lesser curvature was observed in 63.1% (154/244) of cases, gland polyps in 19.6% (48/244), linear streaks in 15.5% (38/244), hematin spots in 15.9% (39/244) and diffuse redness in 9% (22/244). The presence of RAC, gland polyps and diffuse redness were significantly associated with higher prevalence of HP infection (p<0.001). The best performance was obtained from the presence of RAC in both greater and lesser curvature (AUROC 0.808, p<0.001) with a sensitivity (SEN), specificity (SPE), NPV and PPV respectively of 82.7% (64.2-94.1), 78.8% (72.3-84.4), 96,2% (92-98.3) and 40.8% (33.3-48.7). At multivariate analysis it confirmed to be related to HP-negative status (p=0.01, OR 0.04 95%CI: 0.005-0.481). Lastly, the presence of RAC showed a higher performance in males (AUROC 0.836, SEN 86.6% 59.5-98.3, SPE 80.6% 71.4-87.9, NPV 97.1% 90.3-99.2, PPV 44.1% 33.4-55.3) and in young patients (AUROC 0.846, SEN 80% 51.9-95.6, SPE 89.2% 81.1-94.7, NPV 96.2% 90.1-98.6, PPV 56.7% 40.9-71.3). As expected, the presence of RAC required a very short observation time (29.3 ± 11.0 versus 34.7 ± 11.7 seconds; p=0,001).

Conclusion

The presence of RAC in both the greater and lesser curvatures is the most important and reliable indicator of HP-negative status, and the time required for the evaluation is minimal. Our findings may represent a first step toward avoiding unnecessary random biopsies, promoting a more accurate endoscopic examination focused on the careful assessment of the gastric mucosa

References

Chen YC, et al. Global Prevalence of Helicobacter pylori Infection and Incidence of Gastric Cancer Between 1980 and 2022. Gastroenterology, 2024
Zullo A, et al. Upper Endoscopy in Patients with Extra-Oesophageal Reflux Symptoms: A Multicentre Study. GE Port J Gastroenterol, 2020
Seo JY, et al. Predicting Helicobacter pylori infection from endoscopic features. Korean J Intern Med, 2024
Bisschops R, et al. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy, 2016
Manfredi G, et al. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open, 2021

THE ASSOCIATION BETWEEN REGULAR ARRANGEMENT OF COLLECTING VENULES AND HELICOBACTER PYLORI STATUS: A SINGLE-CENTER ITALIAN EXPERIENCE

Mario Capasso 1, Giorgia Corrà 2, Samanta Romeo 1, Roberto Bertè 1, Antonio Cerrone 1, Flavio Metelli 1, Claudio Londoni 1, Saverio Alicante 1, Stefania Bertolazzi 1, Guido Manfredi 1

1 Gastroenterology and Digestive Endoscopy Department, ASST Crema Maggiore Hospital, Crema (CR), Italy, Crema (CR), Italy

2 Gastroenterology and Digestive Endoscopy Unit, Azienda ULSS7 Pedemontana, Bassano del Grappa, Italy|||Gastroenterology and Digestive Endoscopy Department, ASST Crema Maggiore Hospital, Crema (CR), Italy, Crema (CR), Italy

Conference

UEG Week Berlin 2025

Topics

Stomach & H. Pylori

Submission format

Abstract

Session

H. pylori: From epidemiology to therapy (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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