Medtronic Initiates Global Study of 1-Month DAPT After Implantation of Resolute Onyx DES
August 14, 2017—Medtronic announced a global randomized clinical trial that will evaluate 1-month dual antiplatelet therapy (DAPT) in patients who have undergone implantation of the company's Resolute Onyx drug-eluting stent (DES) during percutaneous coronary intervention (PCI). Professor Stephan Windecker, MD, of Bern University Hospital in Bern, Switzerland, is Principal Investigator in the study.
The Resolute Onyx One-Month DAPT study is designed to evaluate clinical DAPT outcomes between two DESs with the intention of helping to inform DAPT guidelines for newer-generation DESs that currently favor bare-metal stents (BMSs) for patients with stable ischemic heart disease who might require a shorter dual antiplatelet regimen. The study will enroll up to approximately 2,000 patients at approximately 70 sites worldwide.
According to the company, the study joins Medtronic's earlier ZEUS trial of its zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates to provide relevant DAPT evidence to physicians for both current and previous-generation DESs. ZEUS showed significant safety benefits with a previous-generation DES versus BMS in patients who would typically not receive a DES, such as those at a high risk for bleeding.
In Medtronic's announcement, Prof. Windecker commented, “The ZEUS trial, and subsequently the LEADERS-FREE trial (which evaluated a different DES versus BMS), showed that other DES systems could be a better alternative to BMSs in patients with a high risk of bleeding."
He continued, "The study addresses the critical question of whether newer generation durable-polymer DESs, like the 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 1 month.
Medtronic noted that guidelines regarding DAPT therapies vary geographically and by patient presentation; additionally, 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 DES received European CE Mark in September 2014 and US Food and Drug Administration approval in April 2017, advised Medtronic.