Data presented yesterday at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21-25 September, San Diego, USA) indicate that there were no significant differences in the rate of target vessel failure between all-comer patients who underwent percutaneous coronary intervention (PCI) with Resolute Onyx (Medtronic) and those who underwent PCI with Orsiro (Biotronik). However, stent thrombosis was significantly lower with Resolute Onyx.
The BIONYX study was an all-comers analysis in nearly 2,500 patients that compared the safety and efficacy of the durable polymer Resolute Onyx device to the Orsiro biodegradable polymer stent device. At one year, the rate of the composite primary endpoint – target vessel failure – was 4.5% for Resolute Onyx vs. 4.7% for Orsiro; a non-significant difference, meaning Resolute Onyx was non-inferior to Orsiro. However, Resolute Onyx was associated with a significantly lower rate of definite or probable stent thrombosis: 0.1% vs. 0.7% for Orsiro (p = 0.01).
Clemens von Birgelen (University of Twente, Enscheded, the Netherlands), who presented the study at TCT, comments: “Never before has a head-to-head stent trial assessed the new-generation durable polymer zotarolimus-eluting stent (Resolute Onyx), which has thinner struts and improved visibility compared to its predecessor (Resolute Integrity). Resolute Onyx demonstrated excellent safety and efficacy that matched at one-year the results of a biodegradable polymer sirolimus-eluting stent with ultra-thin struts that showed excellent outcomes in previous head-to-head stent studies. The stent thrombosis data are promising, but should not be overestimated as we cannot exclude a play of chance.”
Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, states: “We have yet to see any meaningful clinical benefit with the introduction of biodegradable stent technologies. The Resolute Onyx drug-eluting stent has been shown to deliver excellent outcomes for a wide range of patients, and we are pleased to see that the combination of visibility, thin struts, conformability, and biocompatibility resulted in a very low stent thrombosis rate in this study.”
The study was simultaneously published in The Lancet.