Antithrombotic Management and Long-Term Outcomes of Patients with Atrial Fibrillation. Insights from CRAFT Trial.

Paweł Balsam,Bartosz Krzowski,Krzysztof Ozierański,Grzegorz Opolski,Andrzej Śliwczyński,Monika Gawałko,Leszek Kraj,Janusz Bednarski,Marcin Grabowski,Piotr Lodziński,Cezary Maciejewski,Agata Tymińska

doi:10.3390/jcm10081780

Abstract

Background: We aimed to compare long-term outcomes in Polish patients with atrial fibrillation (AF) according to oral anticoagulation (OAC) type and to evaluate the predictive value of common thromboembolic and bleeding risk scores. Methods: Data from the CRAFT trial (NCT02987062) were included. The primary study endpoint was major adverse event (MAE; all-cause death, thromboembolic and hemorrhagic event) during the mean four-year follow-up period. Results: Out of 2983 patients with available follow-up data, 1686 (56%) were prescribed with vitamin K antagonist (VKA), 891 (30%) with rivaroxaban and 406 (14%) with dabigatran. Predominance of elderly and female patients with previous history of thromboembolic and hemorrhagic events was observed within rivaroxaban (vs. other OAC) group. Higher rate of MAEs and its components was observed in patients on VKA followed by rivaroxaban as compared to patients on dabigatran (43% vs. 42% vs. 31%, p < 0.01). After group matching based on clinical characteristics, higher risk of hemorrhagic events in VKA (vs. dabigatran) and rivaroxaban (vs. dabigatran) group were observed. The available thromboembolic (CHA2DS2-VASs, ATRIA, R2CHADS2) and bleeding (HAS-BLED, ATRIA, ORBIT) risk scores showed poor prediction value. Conclusions: Despite no difference in the thromboembolic event rate, treatment with VKA and rivaroxaban was associated with a significant increase in the risk of hemorrhagic events.

Highlights

Oral anticoagulation (OAC) therapy can prevent the majority of ischemic strokes in patients with atrial fibrillation (AF) and can prolong life [1]
Long-term OAC with a vitamin K antagonists (VKAs) or non-VKA OACs (NOACs) [2] conveys benefits in AF patients who survived a stroke with slightly better outcomes, mainly driven by fewer intracranial hemorrhages and hemorrhagic strokes [2]
The ATRIA thromboembolic risk score was calculated by adding 1 point for each of the following factors: female sex, diabetes mellitus, congestive heart failure, hypertension and renal dysfunction and by adding 0–9 points depending on the specific score weighting of patients age according to the presence or absence of prior ischemic stroke

Summary

Introduction

Oral anticoagulation (OAC) therapy can prevent the majority of ischemic strokes in patients with atrial fibrillation (AF) and can prolong life [1]. Higher risk of major bleeding is reported for rivaroxaban than with dabigatran therapy, as was all-cause mortality and gastrointestinal bleeding with similar rate of stroke or systemic embolic events in those subgroups [4]. We aimed to compare long-term outcomes in Polish patients with atrial fibrillation (AF) according to oral anticoagulation (OAC) type and to evaluate the predictive value of common thromboembolic and bleeding risk scores. Higher rate of MAEs and its components was observed in patients on VKA followed by rivaroxaban as compared to patients on dabigatran

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