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. 2021 Mar 21:14:1756284821997352.
doi: 10.1177/1756284821997352. eCollection 2021.

Burden of major gastrointestinal bleeding among oral anticoagulant-treated non-valvular atrial fibrillation patients

Steven Deitelzweig  1 , Allison Keshishian  2 , Amiee Kang  3 , Amol D Dhamane  3 , Xuemei Luo  4 , Neeraja Balachander  3 , Lisa Rosenblatt  3 , Jack Mardekian  5 , Jenny Jiang  3 , Huseyin Yuce  6 , Gregory Y H Lip  7
Affiliations

Burden of major gastrointestinal bleeding among oral anticoagulant-treated non-valvular atrial fibrillation patients

Steven Deitelzweig et al. Therap Adv Gastroenterol. .

Abstract

Background: Gastrointestinal (GI) bleeding is the most common type of major bleeding associated with oral anticoagulant (OAC) treatment. Patients with major bleeding are at an increased risk of a stroke if an OAC is not reinitiated.

Methods: Non-valvular atrial fibrillation (NVAF) patients initiating OACs were identified from the Centers for Medicare and Medicaid Services (CMS) Medicare data and four US commercial claims databases. Patients who had a major GI bleeding event (hospitalization with primary diagnosis of GI bleeding) while on an OAC were selected. A control cohort of patients without a major GI bleed during OAC treatment was matched to major GI bleeding patients using propensity scores. Stroke/systemic embolism (SE), major bleeding, and mortality (in the CMS population) were examined using Cox proportional hazards models with robust sandwich estimates.

Results: A total of 15,888 patients with major GI bleeding and 833,052 patients without major GI bleeding were included in the study. Within 90 days of the major GI bleed, 58% of patients discontinued the initial OAC treatment. Patients with a major GI bleed had a higher risk of stroke/SE [hazard ratio (HR): 1.57, 95% confidence interval (CI): 1.42-1.74], major bleeding (HR: 2.79, 95% CI: 2.64-2.95), and all-cause mortality (HR: 1.29, 95% CI: 1.23-1.36) than patients without a major GI bleed.

Conclusion: Patients with a major GI bleed on OAC had a high rate of OAC discontinuation and significantly higher risk of stroke/SE, major bleeding, and mortality after hospital discharge than those without. Effective management strategies are needed for patients with risk factors for major GI bleeding.

Keywords: atrial fibrillation; gastrointestinal bleeding; major bleeding; oral anticoagulants; stroke.

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Conflict of interest statement

Conflict of interest statement: S Deitelzweig is a consultant for Bristol Myers Squibb Company/Pfizer Inc., Daiichi-Sankyo, Portola, and Boehringer Ingelheim, and has been on the speakers’ bureau for Bristol Myers Squibb Company/Pfizer Inc., and Boehringer Ingelheim. A Keshishian is a paid employee of STATinMED Research which is a paid consultant to Pfizer Inc. and Bristol-Myers Squibb Company. A Kang, A Dhamane, N Balachander, L Rosenblatt, and J Jiang are paid employees and shareholders of Bristol-Myers Squibb Company. X Luo and J Mardekian are paid employees and shareholders of Pfizer, Inc. GYH Lip is a consultant for Bayer/Janssen, BMS/Pfizer, Medtronic, Boehringer Ingelheim, Novartis, Verseon and Daiichi-Sankyo. Speaker for Bayer, BMS/Pfizer, Medtronic, Boehringer Ingelheim, and Daiichi-Sankyo. No fees are directly received personally.

Figures

Figure 1.
Figure 1.
Patient selection criteria. AF, atrial fibrillation; GI, gastrointestinal; ICD-9/10-CM, International Classification of Diseases – 9th/10th Revision – Clinical Modification; OAC, oral anticoagulant; VTE, venous thromboembolism.
Figure 2.
Figure 2.
Kaplan–Meier curves for stroke/systemic embolism and major bleeding for patients with and without major GI bleeding in the propensity score matched population. GI, gastrointestinal.
Figure 3.
Figure 3.
Propensity score matched incidence rates and hazard ratios of stroke/SE and major bleeding for patients with and without major GI bleeding. Note. Major GI bleeding and peptic ulcers were included as covariates in the Cox proportional hazards models as they were unbalanced after propensity score matching. CI, confidence interval; GI, gastrointestinal; ICH, intracranial hemorrhage; SE, systemic embolism.
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