Medtronic has announced a global randomised clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT) in patients implanted with the Resolute Onyx drug-eluting stent (DES) during percutaneous coronary intervention (PCI).
Designed to evaluate clinical DAPT outcomes between two drug eluting stents for the first time ever, the RESOLUTE ONYX ONE-MONTH DAPT Study intends to help inform DAPT guidelines for newer-generation drug-eluting stents that currently favour bare-metal stents (BMS) for patients with stable ischaemic heart disease who might require a shorter dual antiplatelet regimen.
Guidelines regarding DAPT therapies vary geographically and by patient presentation. The RESOLUTE ONYX ONE-MONTH DAPT Study will enrol up to approximately 2,000 patients at approximately 70 sites worldwide.
“The ZEUS trial and subsequently, the LEADERS-FREE trial (which evaluated a different DCS vs. BMS), showed that other drug-eluting systems could be a better alternative to BMS in patients with a high risk of bleeding,” says Stephan Windecker, of Bern University Hospital in Bern, Switzerland, and principal investigator in the study. “The study addresses the critical question whether newer generation durable-polymer drug-eluting stets, like Resolute Onyx, that have demonstrated excellent procedural success in addition to sustained long-term safety and efficacy, could potentially improve results even further among these patients.”
Results from the RESOLUTE ONYX ONE-MONTH DAPT Study will also build on the RESOLUTE Pooled DAPT Interruption analysis that showed no increased risk of stent thrombosis with DAPT interruption or discontinuation after one-month.
The Resolute Onyx DES is the first and only DES to feature Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. This is designed to enable greater deliverability and conformability to the vessel wall.
With Core Wire Technology, a radiopaque inner core is incorporated within the cobalt alloy wire to enhance visibility for accurate stent placement. Core Wire Technology is also intended to enable thinner struts while maintaining structural strength.
Stents from the Resolute drug eluting stent family have been implanted in more than six million patients around the world, one million of whom have been implanted with the latest-generation Resolute Onyx DES. The device received CE mark in September 2014 and US Food and Drug (FDA) approval in April 2017.