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.

Kedhi, Elvin; Latib, Azeem; Abizaid, Alexandre; Kandzari, David; Kirtane, Ajay J; Mehran, Roxana; Price, Matthew J; Simon, Daniel; Worthley, Stephen; Zaman, Azfar; Brar, Sandeep; Liu, Minglei; Stone, Gregg W; Windecker, Stephan (2019). 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. American Heart Journal, 214, pp. 134-141. Elsevier 10.1016/j.ahj.2019.04.017

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0002-8703

Publisher:

Elsevier

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

11 Feb 2020 07:25

Last Modified:

11 Feb 2020 07:25

Publisher DOI:

10.1016/j.ahj.2019.04.017

PubMed ID:

31203158

BORIS DOI:

10.7892/boris.139134

URI:

https://boris.unibe.ch/id/eprint/139134

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