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Bleeding Risk of Add-On Anti-Platelet Agents to Direct Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation (From 2216 Patients in the DIRECT Registry)
- Source :
- The American Journal of Cardiology. 123:1293-1300
- Publication Year :
- 2019
- Publisher :
- Elsevier BV, 2019.
-
Abstract
- Clinical outcomes of the real-world Asian nonvalvular atrial fibrillation (NVAF) patients treated with DOAC and the incremental bleeding risk of add-on antiplatelet therapy to direct oral anticoagulants (DOACs) are still to be investigated. We conducted a single-center prospective observational registry of NVAF patients treated with DOACs: the DIRECT registry (UMIN000033283). All patients with NVAF (N = 2216) who were users of dabigatran (N = 648), rivaroxaban (N = 538), apixaban (N = 599), or edoxaban (N = 431) from June 2011 to November 2017 were enrolled (71.6 ± 10.8 years, 36.4% female, follow-up duration: 407.2 ± 388.3 days). No add-on antiplatelet agent was prescribed to 1,739 patients, while single and dual antiplatelet therapy (SAPT and DAPT) in combination with DOAC were prescribed to 411 and 66 patients, respectively. The primary safety endpoint was any bleeding which was defined as a composite of major bleeding according to the International Society on Thrombosis and Hemostasis criteria and clinically relevant non-major bleeding. Patients treated with add-on antiplatelet agents irrespective of SAPT or DAPT had a higher any-bleeding risk than those without (hazard ratio: 1.42; 95% confidence interval 1.16-1.74, p = 0.001). Multivariate adjusted hazard of add-on antiplatelet therapy was not statistically significant (hazard ratio: 1.20; 95% confidence interval 0.94-1.53, p = 0.147). In conclusion, NVAF patients treated with antiplatelet agents and DOAC had a significantly higher bleeding risk than those using DOAC only. However, after adjustment of patients' background, add-on antiplatelet therapy to DOAC itself did not influence to a bleeding risk.
- Subjects :
- Male
medicine.medical_specialty
Pyridines
Pyridones
Administration, Oral
Hemorrhage
030204 cardiovascular system & hematology
Antithrombins
Dabigatran
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Japan
Rivaroxaban
Edoxaban
Internal medicine
Atrial Fibrillation
medicine
Humans
Prospective Studies
Registries
030212 general & internal medicine
Aged
business.industry
Incidence
Hazard ratio
Atrial fibrillation
Middle Aged
Prognosis
medicine.disease
Thrombosis
Thiazoles
chemistry
Hemostasis
Cardiology
Pyrazoles
Drug Therapy, Combination
Female
Apixaban
Cardiology and Cardiovascular Medicine
business
Platelet Aggregation Inhibitors
Factor Xa Inhibitors
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 00029149 and 00003328
- Volume :
- 123
- Database :
- OpenAIRE
- Journal :
- The American Journal of Cardiology
- Accession number :
- edsair.doi.dedup.....f4edb71f2787a42688bd45c31038c9b4
- Full Text :
- https://doi.org/10.1016/j.amjcard.2019.01.027