# Clinical and Economic Impact of a First Major Bleeding Event in Non-Anticoagulated Patients in Spain: A 3-Year Retrospective Observational Cohort Study

## TL;DR

This study examines the health and economic effects of first major bleeding events in non-anticoagulated patients in Spain over three years.

## Contribution

The study provides new insights into the clinical outcomes and healthcare costs associated with first major bleeding events in non-anticoagulated patients.

## Key findings

- About 57% of the major bleeding costs were attributed to in-hospital treatment.
- The risk of adverse clinical events decreased over time following a major bleeding event.
- Intracranial hemorrhage had the highest mortality rate at 5.51% after the event.

## Abstract

Objective: To analyze clinical characteristics of non-anticoagulated subjects with major bleeding, and to determine the incidence of adverse events, healthcare resource utilization (HCRU) and associated costs following a major bleeding event. Methods: Retrospective observational cohort study that analyzed secondary data from electronic health records in Spain. Non-anticoagulated patients with a first major bleeding during the study period (between January 2013 and December 2022) were analyzed for 3 years. Results: A total of 4089 patients (mean age 57.26 (12.87) years, 58.47% female) were included. A proportion of 27.63% presented with genitourinary bleeding, 22.43% with gastrointestinal bleeding, 5.16% with respiratory bleeding and 3.11% with intracranial hemorrhage. At the end of the first major bleeding event, 0.56% of patients died (5.51% after intracranial hemorrhage, 3.23% in case of trauma-related bleeding). The incidence rates of clinical outcomes per 100 person-years within the first 3 months of the major bleeding were death from any cause 7.51 (95% CI 6.70–8.32), cardiovascular death 1.80 (95% CI 1.39–2.21), acute myocardial infarction 4.53 (95% CI 3.89–5.17), and ischemic stroke 3.52 (95% CI 2.96–4.08), and decreased over time. At year 3, mean overall major bleeding cost per patient was EUR 13,310.00 (5153.05), of which EUR 7648.20 (2674.46) (57.46%) accounted for in-hospital costs to treat the major bleeding event. Conclusions: Among non-anticoagulated patients presenting with a first major bleeding, <1% of patients died during index hospitalization. However, these patients had a substantial risk of adverse clinical events during the follow-up, as well as high associated HCRU and costs.