Rationale and design of the Onyx ONE global randomized trial: a randomized controlled trial of high-bleeding risk patients after stent placement with 1month of dual antiplatelet therapy
Am. heart j
; 214: 134-141, Jul. 2019. ilus, tab
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1009228
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
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 11 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 1month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end 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 1year. Patient follow-up is planned for 1, 2, and 6months and 1 and 2years 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 1month of DAPT.
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Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Inibidores da Agregação Plaquetária
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Stents
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Hemorragia
Tipo de estudo:
Ensaio clínico controlado
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Estudo de etiologia
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Fatores de risco
Idioma:
Inglês
Revista:
Am. heart j
Ano de publicação:
2019
Tipo de documento:
Artigo
Instituição/País de afiliação:
NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation+US
/
Department of Cardiology, Montefiore Medical Center/US
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Department of Cardiology, Mount Sinai Medical Center/US
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Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital/CH
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Department of Cardiovascular Diseases, Scripps Clinic/US
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Freeman Hospital and Newcastle University/GB
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Instituto Dante Pazzanese de Cardiologia/BR
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Isala Hartcentrum/NL
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Medtronic/US
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Piedmont Atlanta Hospital/US