Clinical Study of Medtronic's Resolute Onyx 2.0-mm DES for Extra Small Vessels Meets Primary Endpoint
May 18, 2017—Medtronic announced that the Resolute Onyx 2.0-mm drug-eluting stent (DES) met its primary endpoint of target lesion failure (TLF) at 1 year for the treatment of coronary artery disease in extra-small vessels. Results from the RESOLUTE ONYX 2.0 mm clinical study were presented by Matthew J. Price, MD, during a Hot Line/Late-Breaking Trial Session at the EuroPCR 2017 conference in Paris, France, and simultaneously published in the Journal of the American College of Cardiology: Cardiovascular Intervention.
According to Medtronic, the Resolute Onyx 2.0-mm DES, which is designed specifically for extra-small vessels, yielded excellent clinical outcomes in the study compared to a prespecified performance goal with patients experiencing significantly low rates of TLF at 1 year (5%; P ≤ .001). The study enrolled 101 patients with extra-small vessel sizes (2–2.25 mm) who received the Resolute Onyx 2.0-mm DES at 20 sites in the United States and Japan.
In the study, the events included in the TLF primary endpoint were low at 1 year, as defined by low target vessel myocardial infarction (3%), low target lesion revascularization (2%), and no cardiac death. Additionally, the Resolute Onyx 2.0-mm DES showed no stent thrombosis.
Dr. Price, who is Principal Investigator of the study, commented in the company's announcement, “Treating coronary disease in extremely small arteries presents a real clinical challenge, as these lesions tend to be located in difficult-to-reach areas of the heart, have greater restenosis rates, and until now, we lacked the right stents to treat them safely and successfully. The excellent clinical performance we observed demonstrates the importance of designing stents like the Resolute Onyx 2.0-mm DES that address a relevant unmet need. Thinner struts with enhanced radiopacity and a lower crossing profile provide excellent deliverability, and the stent can be over-expanded to treat tapered, challenging lesions.” Dr. Price is an interventional cardiologist at Scripps Clinic in La Jolla, California.
Medtronic advised that the Resolute Onyx 2.0-mm DES is available for investigational use only in the United States. The Resolute Onyx DES, which is available in sizes from 2.25 to 5 mm is approved by the US Food and Drug Administration and has European CE Mark approval.