Design of the PERSEO Registry on the management of patients treated with oral anticoagulants and coronary stent.
Administration, Oral
Anticoagulants
Atrial Fibrillation
/ drug therapy
Coronary Artery Disease
/ drug therapy
Drug Therapy, Combination
Fibrinolytic Agents
/ therapeutic use
Hemorrhage
/ etiology
Humans
Percutaneous Coronary Intervention
/ adverse effects
Platelet Aggregation Inhibitors
Registries
Stents
Vitamin K
Warfarin
Journal
Journal of cardiovascular medicine (Hagerstown, Md.)
ISSN: 1558-2035
Titre abrégé: J Cardiovasc Med (Hagerstown)
Pays: United States
ID NLM: 101259752
Informations de publication
Date de publication:
01 11 2022
01 11 2022
Historique:
pubmed:
28
9
2022
medline:
19
10
2022
entrez:
27
9
2022
Statut:
ppublish
Résumé
Percutaneous coronary intervention with stent implantation (PCI-S) in patients requiring chronic oral anticoagulant therapy (OAC) is associated with an increased risk of bleeding and ischemic complications. Different randomized studies showed a significant advantage of a double antithrombotic therapy and superiority of direct oral anticoagulant (DOAC) compared with warfarin, but real-world data are limited. Aim is to evaluate the antithrombotic management and clinical outcome of patients with an indication for OAC who undergo PCI-S in a 'real-world' setting. The multicentre prospective observational PERSEO (PERcutaneouS coronary intErventions in patients treated with Oral anticoagulant therapy) Registry (ClinicalTrials.gov Identifier: NCT03392948) has been designed to enrol patients requiring OAC treated by PCI-S in 25 Italian centres. A target of at least 1080 patients will be followed for 1 year and data on thromboembolic and bleeding events and changes in antithrombotic therapy will be registered. The primary end point is a combined measure of efficacy and safety outcome (NACE), including major bleeding events and major adverse cardiac and cerebral events at 1-year follow-up in patients treated with DOAC (and dual or triple antiplatelet therapy) compared with the corresponding strategies with vitamin K antagonists. A secondary prespecified analysis has been defined to evaluate NACE in dual versus triple antithrombotic therapy after hospital discharge at 1-year follow-up. The PERSEO Registry will investigate in a 'real world' setting the safety and efficacy of DOAC versus warfarin and dual versus triple antithrombotic therapy in patients with indication for oral anticoagulant therapy who undergo PCI-S.
Identifiants
pubmed: 36166340
doi: 10.2459/JCM.0000000000001372
pii: 01244665-202211000-00007
doi:
Substances chimiques
Anticoagulants
0
Fibrinolytic Agents
0
Platelet Aggregation Inhibitors
0
Vitamin K
12001-79-5
Warfarin
5Q7ZVV76EI
Banques de données
ClinicalTrials.gov
['NCT03392948']
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
738-743Informations de copyright
Copyright © 2022 Italian Federation of Cardiology - I.F.C. All rights reserved.
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