Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy.
Aspirin
/ adverse effects
Drug Therapy, Combination
Drug-Eluting Stents
/ adverse effects
Hemorrhage
/ chemically induced
Humans
Immunosuppressive Agents
/ therapeutic use
Platelet Aggregation Inhibitors
/ adverse effects
Prospective Studies
Prosthesis Design
Receptors, Purinergic P2Y12
Research Design
Risk
Single-Blind Method
Sirolimus
/ analogs & derivatives
Stents
/ adverse effects
Thrombosis
/ prevention & control
Journal
American heart journal
ISSN: 1097-6744
Titre abrégé: Am Heart J
Pays: United States
ID NLM: 0370465
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
05
01
2019
accepted:
26
04
2019
pubmed:
17
6
2019
medline:
7
3
2020
entrez:
17
6
2019
Statut:
ppublish
Résumé
Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month DAPT. The safety and efficacy of the newer-generation durable-polymer DES Resolute Onyx compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown. The Onyx ONE global randomized trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1 month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end point is the composite end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1 year. Patient follow-up is planned for 1, 2, and 6 months and 1 and 2 years after the procedure. The Onyx ONE global randomized trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1 month of DAPT.
Sections du résumé
BACKGROUND AND RATIONALE
Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month DAPT. The safety and efficacy of the newer-generation durable-polymer DES Resolute Onyx compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown.
TRIAL DESIGN
The Onyx ONE global randomized trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1 month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end point is the composite end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1 year. Patient follow-up is planned for 1, 2, and 6 months and 1 and 2 years after the procedure.
CONCLUSIONS
The Onyx ONE global randomized trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1 month of DAPT.
Identifiants
pubmed: 31203158
pii: S0002-8703(19)30106-1
doi: 10.1016/j.ahj.2019.04.017
pii:
doi:
Substances chimiques
Immunosuppressive Agents
0
P2RY12 protein, human
0
Platelet Aggregation Inhibitors
0
Receptors, Purinergic P2Y12
0
zotarolimus
H4GXR80IZE
Aspirin
R16CO5Y76E
Sirolimus
W36ZG6FT64
Banques de données
ClinicalTrials.gov
['NCT03344653']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
134-141Informations de copyright
Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.