July 30, 2014 — OrbusNeich announced the first patient has been enrolled in the Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) post-marketing registry. The first Combo dual therapy stent implant was performed at the Amphia Hospital in Breda, The Netherlands.
Designed to assess the long-term safety and effectiveness of the Combo stent in routine clinical practice, the prospective, multicenter registry is the largest clinical study of the unique dual therapy stent to date, with a goal of 2,500 patients being followed for a year in up to 50 centers across Asia and Europe.
The study's primary endpoint is device-oriented target lesion failure (TLF), defined as the composite of cardiac death, non-fatal heart attack (myocardial infarction or MI) not clearly attributable to a non-target vessel, or target lesion revascularization (TLR) from enrollment to 12 months.
The principal investigator is Antonio Colombo, M.D., San Raffaele Hospital, Milan, Italy; the director of the clinical coordinating center is Roxana Mehran, M.D., Mount Sinai Medical Center.
"Long-term safety remains an important area of clinical investigation with stents, particularly the avoidance of neoatherosclerosis and late stent thrombosis," said Colombo. "The MASCOT registry will provide important information about the unique dual therapy approach of the Combo stent, which offers the possibility of functional arterial vessel healing, which we have not seen with any of the monotherapy drug-eluting stents."
"The clinical data gathered from Combo stent trials to date show promise with respect to long-term safety and efficacy," added Mehran. "For example, TLR remained stable at 5.7 percent in both years two and three of the REMEDEE trial, with no thrombotic events over three years. If those results hold in the MASCOT registry, that will be good news for patients and cardiologists."
OrbusNeich is supporting the Combo stent with a robust clinical program. In addition to the MASCOT registry, the REDUCE trial, which enrolled its first patient in June 2014, aims to demonstrate the potential for a shorter period of dual antiplatelet therapy.
"The initiation of MASCOT, our largest registry trial to date, represents the commitment we have made to really understand the patient benefits of the Combo stent," said B. Wayne Johnson, president and chief operating officer, OrbusNeich. "Only by delivering true vessel healing can patients feel safe for the long term. We expect the MASCOT trial to confirm what we have already seen with the Combo stent as it relates to vessel healing."
For more information: www.orbusneich.com