Medtronic is recruiting patients for a randomized clinical trial that will investigate one-month dual-antiplatelet therapy (DAPT) in patients who have been implanted with Resolute Onyx, the company’s latest drug-eluting stent.
Bare metal and drug-eluting stents are implanted in coronary arteries to prop them open. Drug-eluting stents are designed to prevent scar tissue from forming in the artery and necessitating a follow-up procedure. After receiving a stent, patients typically receive DAPT, a combination of aspirin and a second anticlotting medication. However, Medtronic notes, guidelines for DAPT “vary geographically and by patient presentation.”
The new trial will enroll up to 2,000 patients and will take place at about 70 sites worldwide, the devicemaker said in a statement. It will assess DAPT outcomes for patients implanted with either the Resolute Onyx stent or another drug-eluting stent. Current DAPT guidelines favor bare metal stents for patients with stable ischemic heart disease; the study is intended to inform DAPT guidelines for the newer drug-eluting stents.
"We're continuously looking at ways to invest in clinical evidence and expand our product portfolio to help address the most important unanswered questions and unmet needs in interventional cardiology," said Martin Rothman, M.D., vice president of medical affairs for Medtronic’s Coronary and Structural Heart division, in the statement. "In addition to generating new, meaningful evidence to help guide clinical practice, we are also looking to develop next-generation technologies that will build on the exceptional deliverability that physicians have come to expect with our stent platforms.”
The Resolute Onyx bagged FDA clearance in May, but the device has been on the European market for two years. Made of a single strand of cobalt alloy wire with a platinum-iridium core, the device has thinner struts and is more flexible without sacrificing strength. It is the largest drug-eluting stent available in the U.S.