Hemorrhagic Complications in Patients with Atrial Fibrillation Treated with Novel Oral Anticoagulants - Results from the CRAFT Study

Sep 30, 2026

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Hemorrhagic complications are common adverse events of anticoagulant therapy in atrial fibrillation (AF), while non-vitamin K antagonist oral anticoagulants (DOACs) are used to better prevent thromboembolism than vitamin K antagonists (VKAs). This study aimed to identify clinical factors linked to bleeding in AF patients treated with DOACs and to build a practical bleeding risk score. Retrospective analysis used multicenter CRAFT trial data from 1435 patients treated with dabigatran or rivaroxaban. Nine predictors formed the CRAFT bleeding score.

LanguageEnglish

CategoryHealthcare

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Pages9

Reading Time23 min

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Abstract

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Methods

Results

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Introduction

Materials and Methods

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Article Hemorrhagic Complications in Patients with Atrial Fibrillation Treated with Novel Oral Anticoagulants: Results from the CRAFT Study Marek Styczkiewicz 1, Mateusz Wawrze ´nczyk 2, *, Adam Sukiennik 2, Bartosz Krzowski 2, Cezary Maciejewski 2, Piotr Lodzi ´nski 2, Leszek Kraj 3, Grzegorz Opolski 2, Marcin Grabowski 2, Paweł Balsam 2 and Michał Peller 2 Academic Editor: Attila Nemes Received: 25 October 2025 Revised: 10 December 2025 Accepted: 15 December 2025 Published: 27 December 2025 Copyright: © 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. 1 Department of Cardiology, The Pope John Paul II Province Hospital of Zamo´s´c, 22-400 Zamo´s´c, Poland; [styczkiewicz@interia.pl](styczkiewicz@interia.pl) 2 1st Department of Cardiology, Medical University of Warsaw, 02-091 Warsaw, Poland 3 Department of Oncology, Medical University of Warsaw, 02-091 Warsaw, Poland * [Correspondence: mateusz.wawrzenczyk@gmail.com](Correspondence: mateusz.wawrzenczyk@gmail.com) Abstract Background/Objectives: Hemorrhagic complications are among the most common adverse events of anticoagulant therapy in patients with atrial fibrillation (AF) . Non-vitamin K antagonist oral anticoagulants (DOACs) are known to be more effective than vitamin K antagonists (VKAs) in preventing thromboembolism. The aim was to identify clinical factors associated with hemorrhagic events in AF patients treated with DOACs and to develop a simple, clinically applicable bleeding risk score. Methods: Data were derived from the multicenter CRAFT trial (NCT02987062) . We conducted a retrospective analysis of hospital records of 1435 AF patients (median age: 67 years; 44.8% female) treated with dabigatran or rivaroxaban. The main study endpoints were the occurrence of a bleeding episode, thromboembolic episode, or all-cause death during a mean four-year followup (1531 [1062–2140] days) . Results: The rates of bleeding episodes, thromboembolic episodes, and all-cause death were 17.4%, 13.5%, and 23.9%, respectively. Nine factors were identified as predictors of bleeding complications: male sex, history of major bleeding, history of cancer, COPD, CRT, rivaroxaban therapy, statin therapy, age, and absence of heart failure. Based on these, the CRAFT bleeding score was developed to predict the risk of hemorrhagic events in individual patients. Conclusions: The CRAFT bleeding score may be implemented in AF patients as an additional tool for evaluating DOACs safety prior to initiating anticoagulant therapy, and for guiding closer monitoring of high-risk individuals to minimize bleeding complications. Keywords: atrial fibrillation; bleeding risk score; anticoagulant therapy; DOACs 1. Introduction Anticoagulant therapy is essential for patients with atrial fibrillation (AF), as it prevents thrombotic complications, most importantly ischemic stroke. Except for patients at very low thrombotic risk, it is widely used [1–3] . However, it carries well-recognized side effects such as hemorrhagic complications. In recent years, the management of atrial fibrillation has evolved substantially with the introduction of non-vitamin K antagonist oral anticoagulants (DOACs), including dabigatran, rivaroxaban, apixaban, and edoxaban. DOACs have been shown to provide several advantages over vitamin K antagonists (VKAs), both in preventing thromboembolic episodes and reducing the frequency of bleeding complications [4–6] . These agents provide predictable pharmacokinetics, fewer drug–food interactions, and do not require routine INR monitoring, which has significantly improved patient convenience. However, despite their favorable safety profile compared to warfarin, bleeding events remain a relevant clinical concern. Several bleeding risk scores have been proposed, such as HAS-BLED and, more recently, the DOAC score, but th

FAQs

What was the primary goal of the CRAFT study regarding hemorrhagic events?

To identify clinical factors associated with hemorrhagic events in AF patients treated with DOACs and to develop a simple, clinically usable bleeding risk score.

Which DOACs were evaluated in the retrospective cohort?

Patients were treated with dabigatran or rivaroxaban in the CRAFT registry.

What factors were identified as predictors of bleeding complications?

Nine predictors were reported: male sex, history of major bleeding, history of cancer, COPD, CRT, rivaroxaban therapy, statin therapy, age, and absence of heart failure.

Sep 30, 2026

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