Data for the Resolute Onyx drug-eluting 2mm stent (Medtronic), which were presented at EuroPCR (16–19 May, Paris, France), indicate that device is not associated with any stent thrombosis at one year. Additionally, according to the data, the RESOLUTE ONYX 2.0mm study met its primary endpoint of target lesion failure at one year for the treatment of coronary artery disease in extra small vessels.
Designed specifically for extra-small vessels, a press release reports, the Resolute Onyx 2mm drug-eluting stent yielded excellent clinical outcomes in the study compared to a prespecified performance goal. Patients experienced significantly low rates of target lesion failure at one year (5%; p≤0.001). Low target lesion failure was defined as low target-vessel myocardial infarction (3%), low target lesion revascularisation (2%) and no cardiac death. Additionally, the Resolute Onyx drug-eluting stent showed no stent thrombosis. The study enrolled 101 patients with extra-small vessel sizes (2–2.25mm), who received the Resolute Onyx 2mm diameter drug-eluting stent across 20 sites in the USA and Japan.
Principal investigator Matthew J Price (Scripps Clinic, La Jolla, USA) says: “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 DES that address a relevant unmet need. Thinner struts with enhanced radiopacity and a lower crossing profile provides excellent deliverability, and the stent can be over-expanded to treat tapered, challenging lesions.”
The study was simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention.