Study to assess 1-month DAPT with DES

A global randomized clinical trial to evaluate 1-month dual antiplatelet therapy in patients implanted with a drug-eluting stent during PCI has been launched, according to a press release from Medtronic.

The RESOLUTE ONYX ONE-MONTH DAPT study was designed with the intention of informing DAPT guidelines for newer-generation DES for patients with stable ischemic heart disease who require a shorter regimen of DAPT, according to the release.

Current DAPT guidelines vary by geography and patient presentation, and state that decisions about DAPT duration should be made on an individual basis, integrating clinical judgement, benefit to risk ration assessment, product labeling and patient preference, the company stated in the release.

The randomized trial will enroll approximately 2,000 patients implanted with a zotarolimus-eluting stent (Resolute Onyx, Medtronic) at approximately 70 sites globally, according to the release.

“The ZEUS trial and subsequently, the LEADERS-FREE trial showed that other DES systems could be a better alternative to BMS in patients with high risk of bleeding,” Stephan Windecker, MD, of Bern Medical University Hospital in Switzerland, said in the release. “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.”

Disclosure: Windecker reports receiving institutional research grants from Boston Scientific, Edwards Lifesciences and Medtronic.