August 18, 2017 — Medtronic plc announced a global randomized 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 DES for the first time ever, the RESOLUTE ONYX ONE-MONTH DAPT Study intends to help inform DAPT guidelines for newer-generation DES that currently favor bare-metal stents (BMS) for patients with stable ischemic heart disease who might require a shorter dual antiplatelet regimen.
Guidelines regarding DAPT therapies vary geographically and by patient presentation. Decisions about duration of DAPT are best made on an individual basis and should integrate clinical judgment, assessment of the benefit/risk ratio, product labeling, and patient preference. The RESOLUTE ONYX ONE-MONTH DAPT Study will enroll 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 DES systems could be a better alternative to BMS in patients with a high risk of bleeding,” said Stephan Windecker, M.D., of Bern University Hospital in Switzerland, and principal investigator in the study. “The study addresses the critical question whether newer generation durable-polymer DES, 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 features Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is a Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. This enables 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 also enables thinner struts while maintaining structural strength.
The Resolute Onyx DES received CE Mark in September 2014 and U.S. Food and Drug Administration (FDA) approval in April 2017.
For more information: www.medtronic.com