FDA Approves First 2.0-mm Drug-Eluting Stent in US

FDA Approves First 2.0-mm Drug-Eluting Stent in US

The U.S. Food and Drug Administration (FDA) has approved the Resolute Onyx 2.0-mm drug-eluting stent (DES), the smallest DES available in the United States.

The approval addresses an unmet clinical need by expanding treatment options for patients with coronary artery disease in very small vessels, Medtronic noted in its announcement today.

Until now, the smallest-sized DES marketed in the United States was 2.25 mm.

Currently, patients with lesions smaller than 2.25 mm are managed with bare metal stents, oversizing with a 2.25-mm DES, or balloon angioplasty. Smaller preprocedural reference vessel diameter (RVD) is associated with increased target lesion revascularization and worse survival from major adverse cardiovascular events, even in the DES era.

“The Resolute Onyx 2.0 mm DES is an extremely deliverable stent that, when needed, can be post-dilated to 3.25 mm to treat lesions in difficult-to-reach areas of the heart,” Matthew J Price, MD, from Scripps Clinic, La Jolla, California, who co-lead the RESOLUTE 2.0 mm Clinical Study supporting the FDA approval, said in the announcement.

The zotarolimus-eluting stent also has the lowest crossing profile of any DES at less than 1 mm, further enhancing its deliverability.

The RESOLUTE 2.0 study enrolled 101 patients with ischemic heart disease with stable or unstable angina or ischemia and a single or two de novo coronary lesions in separate target vessels with a mean RVD of 1.91 mm, TIMI flow of 2 or greater, and lesion length of 27 mm or less.

As previously reported by theheart.org | Medscape Cardiology, 12-month results showed no stent thrombosis or cardiac deaths and a target lesion failure rate of 5%, which met the performance target of 19%. The major adverse cardiovascular event rate was 5%, driven by 2% target-lesion revascularization and 3% target-vessel MI.

At the time, David Holmes, MD, from the Mayo Clinic, Rochester, Minnesota, who was not involved with the study, agreed that smaller vessels represent “an incredibly important unmet clinical need” but said use of the stent “will be pretty uncommon because in many 2-mm vessels it will be hard to document they have ischemia.”

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