August 17, 2011 — OrbusNeich announced its Genous stent showed no significant difference in target vessel failure (TVF) rate at two years from the Taxus Liberte paclitaxel-eluting stent in patients with de novo coronary artery lesions at high risk for restenosis. The two-year follow-up data from the prospective, randomized TRIAS pilot study were published in Catheterization and Cardiovascular Interventions.
No cases of stent thrombosis (ST) were observed in patients treated with the Genous at two years, compared to five cases of ST observed in four patients treated with Taxus. The cumulative rate of cardiac death or myocardial infarction (MI) was 4.1 percent in the Genous group compared to 6.3 percent in the Taxus group.
"It is noteworthy that we did not see any stent thrombosis in patients with complex lesions treated with the Genous stent," said Marcel Beijk, M.D., of the Academic Medical Center, Amsterdam, and lead author of the paper. "We also saw that the Genous stent tended to have fewer episodes of target lesion revascularization between one and two years."
The single-center study investigated 193 patients, of which 98 received a Genous stent and 95 received a Taxus stent. Dual antiplatelet therapy was prescribed for at least one month after Genous implantation and for at least six months after Taxus implantation.
"For patients with a high risk of restenosis who cannot tolerate the long-term dual antiplatelet therapy normally associated with DES, it is clear that the Genous Stent is an excellent alternative," added Prof. Robbert de Winter, M.D., Ph.D., also of the Academic Medical Center, Amsterdam, and an author of the paper.
The study's primary endpoint was TVF and secondary endpoints included non-cardiac death, target lesion revascularization (TLR), non-target vessel revascularization (TVR) and ST at two-year follow-up. TVF was defined as the composite of cardiac death, myocardial infarction and TVR. High risk of restenosis was defined if one of the following applied: a chronic total occlusion, a stenosis with a length of greater than or equal to 23 mm, a lesion in a coronary artery with a diameter less than or equal to 2.8 mm by visual estimation or any lesion in a diabetic patient.
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