Clinical study shows safety, efficacy outcomes for Medtronic Resolute Onyx DES
Investigators unveiled new clinical data from the physician-initiated BIONYX study, representing the first all-comers analysis in nearly 2,500 patients comparing the safety and efficacy of the durable polymer Resolute Onyx drug-eluting stent from Medtronic to the Orsiro biodegradable polymer stent. At one year, the study showed patients with coronary artery disease who were treated with Orsiro BP-DES received no clinical advantage compared to patients treated with the Resolute Onyx DP-DES, and Orsiro BP-DES demonstrated a higher rate of stent thrombosis. Enrolling approximately 2,500 real-world patients, the BIONYX study had a primary composite endpoint of target vessel failure at one-year and showed no statistically significant difference in outcomes for the Resolute Onyx DP-DES treated group at 4.5% compared to 4.7% with the Orsiro BP-DES. However, notable differences were observed in significantly lower rates of definite or probable stent thrombosis at one year. The Resolute Onyx DES is coated with the proprietary BioLinx polymer, a bio-compatible and non-thrombogenic coating specifically designed for use on DES. Low rates of stent thrombosis have been observed in more than 70,000 real-world clinical study patients, with additional studies underway, including the global Medtronic Onyx ONE Month DAPT Program comprised of two studies designed to investigate safety following one-month of dual anti-platelet therapy discontinuation post-PCI. The Resolute Onyx DES offers the broadest size matrix available and is the first-and-only DES to feature Core Wire Technology which enables thinner struts and greater deliverability while maintaining structural strength and enhanced visibility.