JIM 2020: Onyx ONE study — Dr Gennaro Sardella

Dr Gennaro Sardella (Sapienza University of Rome, Rome, Italy) discusses data from the Onyx ONE study and its implications for clinical practice.

The Onyx ONE study is a randomised controlled trial with Resolute Onyx™ DES in one month dual antiplatelet therapy (DAPT) for high-bleeding risk patients.

1.    What are the Onyx ONE study aims?
2.    Could you describe this study design and the technology used?
3.    Can you summarise the main findings to date?

Filmed on location at JIM 2020. 

Interviewer: Ashlynne Merrifield
Videographer: Dom Woodruff


Transcript Below :

Question 1 : What are the Onyx ONE study aims?

The Onyx ONE, the real first objective of Onyx ONE is to show if it's possible, to give one month DAPT that is very short DAPT that in high-bleeding risk patients. Uh. It compared two stents the Onyx stent from Medtronic and BioFreedom from Biosensors. It's a randomised trial a multicenter, with about one thousand, five hundred patients. 

Question 2 : Could you describe this study design and the technology used?

The study design is on fact [sic] is to compare these two stents it's a very different stent because the Onyx stent, it's a thinner stent. It's an improvement of an old stent that it was Endeavor's sprint that is no more, no longer available. It was compared with BioFreedom that is a drug-coated stent. The stent design is to to give one month of double therapy in patients that were treated with PCI. ..... It's an all-comers study, no lesion exclusion, no vessel exclusion. The only one inclusion criteria is that a patient had to be high bleeding risk according to the academic research consortium. The last definition of high-bleeding and they compared these two stents after one month of double antiplatelet therapy and after one month, only single antiplatelet therapy, or aspirin, or another antiaggregant like ticagrelor or prasugrel or clopidogrel, it's operator, at operator discretion. And the follow-up, it was one-year follow-up in terms of safety, in term of efficacy. Safety, that, MI and bleeding and efficacy in terms of target lesion failure at twelve months. 

Question 3 : Can you summarise the main findings to date?

The main findings were, globally: The study, the Onyx, that met the non-inferiority compared to BioFreedom that it was already studied in another trial, it was Leaders Free, it was not inferior. In fact, the final follow-up, showed that the primary safety endpoint was similar, in terms of rate of death, myocardial infarction and bleeding. ..... If you go inside to the study and if you uh take major details, you can see that there are [sic], global myocardial infarction, it's the same rate but if you see the spontaneous MI, it was lower in the Onyx group respect to BioFreedom and the target lesion failure, it was less in Onyx group than in BioFreedom. It's [sic] another important point is that there is a crossover between the two groups, four percent from Bio- BioFeedom to Onyx ONE, 0.2% from Onyx ONE to BioFreedom. That means that the procedural characteristics, procedural failure of BioFreedom, it was higher, respect to Onyx ONE. But globally the final conclusion, is that there is no difference in terms of primary safety endpoints between the two stents.