On 16 August 2011, OrbusNeich announced that the that the company’s Genous stent showed no significant difference in the rate of target vessel failure at two years compared to the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary artery lesions carrying a high risk for restenosis. The two-year follow-up data from the prospective, randomised TRIAS pilot study were published in Catheterization and Cardiovascular Interventions.
No cases of stent thrombosis were observed in patients treated with the Genous stent at two years, compared to five cases of stent thrombosis observed in four patients treated with Taxus. The cumulative rate of cardiac death or myocardial infarction was 4.1% in the Genous group compared to 6.3% 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, of the Academic Medical Center, Amsterdam, The Netherlands, and lead author of the paper. “We also saw that the Genous stent tended to have fewer episodes of target lesion revascularisation between one and two years.”
The single-centre 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 stent implantation and for at least six months after Taxus stent implantation.
“For patients with a high risk of restenosis who cannot tolerate the long-term dual antiplatelet therapy normally associated with drug-eluting stents, it is clear that the Genous stent is an excellent alternative,” added Robbert de Winter, also of the Academic Medical Center, Amsterdam, and an author of the paper.
The study’s primary endpoint was target vessel failure and secondary endpoints included non-cardiac death, target lesion revascularisation, non-target vessel revascularisation and stent thrombosis at two-year follow-up. Target vessel failure was defined as the composite of cardiac death, myocardial infarction and target vessel revascularisation. 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 23mm, a lesion in a coronary artery with a diameter less than or equal to 2.8mm by visual estimation or any lesion in a diabetic patient.