Clinical and Economic Consequences of a First Major Bleeding Event in Patients Treated with Direct Factor Xa Inhibitors in Spain: A Long-Term Observational Study

被引:0
|
作者
Escobar, Carlos [1 ]
Palacios, Beatriz [2 ]
Villarreal, Miriam [2 ]
Gutierrez, Martin [2 ]
Capel, Margarita [3 ]
Aranda, Unai [4 ]
Hernandez, Ignacio [5 ]
Garcia, Maria [5 ]
Lledo, Laura [5 ]
Arenillas, Juan F. [6 ,7 ]
机构
[1] Univ Hosp La Paz, Dept Cardiol, Madrid 28046, Spain
[2] AstraZeneca, BioPharmaceut Med, Madrid 28050, Spain
[3] AstraZeneca, BioPharmaceut Corp Affairs & Market Access, Madrid 28050, Spain
[4] AstraZeneca, BioPharmaceut Med, Global Med Affairs, Gaithersburg, MD 20878 USA
[5] Atrys Hlth, Madrid 28002, Spain
[6] Hosp Clin Univ, Comprehens Stroke Ctr, Neurol Dept, Valladolid 47003, Spain
[7] Univ Valladolid, Dept Med, Clin Neurosci Res Grp, Valladolid 47003, Spain
关键词
atrial fibrillation; cost; direct oral anticoagulants; healthcare resource utilization; major bleeding; reversal agents; venous thromboembolism; ORAL ANTICOAGULANTS; ATRIAL-FIBRILLATION; WARFARIN; RIVAROXABAN; GUIDELINE; APIXABAN; EDOXABAN; SAFETY;
D O I
10.3390/jcm13144253
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims: Our aims were to describe the clinical characteristics, adverse clinical events, healthcare resource utilization (HCRU) and costs of patients with major bleeding during direct Factor Xa inhibitor (FXai) use. Methods: This is a retrospective cohort study that included secondary data from computerized health records of seven Spanish Autonomous Communities. Patients with a first major bleeding during treatment with a direct FXai were analyzed during a 3-year period. Results: Of 8972 patients taking a direct FXai, 470 (5.24%) had major bleeding (mean age (SD) 77.93 (9.71) years, 61.06% women). The most frequent indications for using FXais were atrial fibrillation (78.09%) and venous thromboembolism (17.66%). Among those with major bleeding, 88.94% presented with gastrointestinal bleeding, 6.81% intracranial bleeding, 2.13% trauma-related bleeding and 4.26% other major bleeding. Prothrombin complex concentrates were used in 63.19%, followed by transfusion of blood products (20.21%) and Factor VIIa (7.66%). In total, 4.26% of patients died in the hospital due to the first major bleeding. At the study end (after 3-year follow-up), 28.94% of the patients had died, 12.34% had a myocardial infarction and 9.15% an ischemic stroke. At year 3, overall bleeding cost was EUR 5,816,930.5, of which 79.74% accounted for in-hospital costs to treat the bleeding episode. Conclusions: Despite the use of replacement agents being high, major events were common, with a 29% mortality at the end of the follow up, and HCRU and costs were high, evidencing the need for new reversal treatment strategies.
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页数:16
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