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 - 14/07/19
, Azeem Latib, MD b, Alexandre Abizaid, MD c, David Kandzari, MD d, Ajay J. Kirtane, MD, SM e, Roxana Mehran, MD f, Matthew J. Price, MD g, Daniel Simon, MD h, Stephen Worthley, MD i, Azfar Zaman, MD j, Sandeep Brar, MD k, Minglei Liu, PhD k, Gregg W. Stone, MD e, Stephan Windecker, MD lAbstract |
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.
Le texte complet de cet article est disponible en PDF.Plan
| RCT No. NCT03344653 |
Vol 214
P. 134-141 - août 2019 Retour au numéro
Article précédent
- Rational and design of the INtentional COronary revascularization versus conservative therapy in patients undergOing successful peripheRAl arTEry revascularization due to critical limb ischemia trial (INCORPORATE trial)
- G. Toth, Marianne Brodmann, Emanuele Barbato, Fabio Mangiacapra, Laura Schneller, Viktor Orias, Robert Gil, Jacek Bil, Stanislaw Bartus, Zoltan Ruzsa
- Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing
- Anne-Floor B.E. Quast, Sarah W.E. Baalman, Tim R. Betts, Lucas V.A. Boersma, Hendrik Bonnemeier, Serge Boveda, Tom F. Brouwer, Martin C. Burke, Peter Paul H.M. Delnoy, Mikhael El-Chami, Juergen Kuschyk, Pier Lambiase, Christelle Marquie, Marc A. Miller, Lonneke Smeding, Arthur A.M. Wilde, Reinoud E. Knops
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?