Bleeding risks associated with anticoagulant therapies after percutaneous coronary intervention in Japanese patients with ischemic heart disease complicated by atrial fibrillation: A comparative study.
Administration, Oral
Aged
Anticoagulants
/ adverse effects
Atrial Fibrillation
/ complications
Female
Hemorrhage
/ chemically induced
Humans
Incidence
Japan
/ epidemiology
Male
Middle Aged
Myocardial Ischemia
/ complications
Percutaneous Coronary Intervention
Postoperative Complications
/ chemically induced
Postoperative Period
Retrospective Studies
Risk Factors
Atrial fibrillation
Bleeding
Direct oral anticoagulant
Ischemic heart disease
Percutaneous coronary intervention
Vitamin K antagonists
Journal
Journal of cardiology
ISSN: 1876-4738
Titre abrégé: J Cardiol
Pays: Netherlands
ID NLM: 8804703
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
26
03
2020
revised:
20
07
2020
accepted:
11
08
2020
pubmed:
19
9
2020
medline:
24
7
2021
entrez:
18
9
2020
Statut:
ppublish
Résumé
Current guidelines recommend early termination of triple therapy and the use of direct oral anticoagulants (DOAC) for non-valvular atrial fibrillation (NVAF) patients who undergo percutaneous coronary intervention (PCI), due to safety concerns. However, to date, real-world medication usage and safety outcomes (specifically bleeding) in NVAF patients with stent implantation have not been well assessed. This was a retrospective, observational, medical database cohort study in Japanese ischemic heart disease (IHD) patients with NVAF who underwent PCI between 2012 and 2017. The primary outcome was clinically relevant bleeding; secondary outcomes included individual bleeding events. A multivariate analysis was conducted to identify risk factors affecting the occurrence of clinically relevant bleeding events. The analysis population comprised 5695 patients [3530 received DOACs and 2165 received vitamin K antagonists (VKAs)]. The incidence of primary outcome events (clinically relevant bleeding/100 patient-years) was 6.05 in the DOAC group and 8.42 in the VKA group, resulting in a nonsignificant 21% lower risk in the DOAC group. The DOAC group also had a nonsignificant 24%, 24%, and 34% lower risk of bleeding requiring transfusion, intracranial bleeding, and lower gastrointestinal bleeding, respectively, compared with the VKA group. A multivariate analysis of the primary outcome showed a significantly higher risk of bleeding among older patients and those with lower body weight and abnormal renal function. In this retrospective real-world evaluation of IHD patients with NVAF and PCI, DOAC-treated patients had a lower risk of developing clinically relevant bleeding compared with the VKA group.
Sections du résumé
BACKGROUND
Current guidelines recommend early termination of triple therapy and the use of direct oral anticoagulants (DOAC) for non-valvular atrial fibrillation (NVAF) patients who undergo percutaneous coronary intervention (PCI), due to safety concerns. However, to date, real-world medication usage and safety outcomes (specifically bleeding) in NVAF patients with stent implantation have not been well assessed.
METHODS
This was a retrospective, observational, medical database cohort study in Japanese ischemic heart disease (IHD) patients with NVAF who underwent PCI between 2012 and 2017. The primary outcome was clinically relevant bleeding; secondary outcomes included individual bleeding events. A multivariate analysis was conducted to identify risk factors affecting the occurrence of clinically relevant bleeding events.
RESULTS
The analysis population comprised 5695 patients [3530 received DOACs and 2165 received vitamin K antagonists (VKAs)]. The incidence of primary outcome events (clinically relevant bleeding/100 patient-years) was 6.05 in the DOAC group and 8.42 in the VKA group, resulting in a nonsignificant 21% lower risk in the DOAC group. The DOAC group also had a nonsignificant 24%, 24%, and 34% lower risk of bleeding requiring transfusion, intracranial bleeding, and lower gastrointestinal bleeding, respectively, compared with the VKA group. A multivariate analysis of the primary outcome showed a significantly higher risk of bleeding among older patients and those with lower body weight and abnormal renal function.
CONCLUSIONS
In this retrospective real-world evaluation of IHD patients with NVAF and PCI, DOAC-treated patients had a lower risk of developing clinically relevant bleeding compared with the VKA group.
Identifiants
pubmed: 32943280
pii: S0914-5087(20)30293-8
doi: 10.1016/j.jjcc.2020.08.008
pii:
doi:
Substances chimiques
Anticoagulants
0
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
186-194Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.