OrbusNeich announced that three-year clinical outcomes data from the use of the Genous stent for percutaneous coronary interventions in a large, real-world patient population demonstrate the device’s long-term safety and efficacy. These results were published in the October issue of the Journal of Interventional Cardiology.
At three-year clinical follow-up, the study’s primary endpoint, a composite of cardiac death, myocardial infarction and target lesion revascularisation, in an unselected patient population was 18.3%. Between one and three years, target lesion revascularisation had increased by only 3.6%, and no cases of late and very late definite stent thrombosis were observed.
“This is the first report of three-year clinical outcomes for the Genous stent, and it is important to recognise that only a small number of studies have ever reported on three-year outcomes following percutaneous coronary intervention with stent placement in an all-comer population,” said Margo Klomp, Academic Medical Center, Amsterdam, and lead author of the publication. “The target lesion failure rate of 18.3% in this case is on the lower end of the spectrum versus reported drug-eluting stent outcomes. In addition, late and very late stent thrombosis was absent in our Genous stent treated cohort, whereas other registries have reported occurrence of late and very late stent thrombosis in drug-eluting stent treated patients.”
The single-centre study included 405 unselected patients with mostly complex lesions with an estimated high risk of restenosis. Specifically, 47% of the patients had multivessel disease, and, of the lesions treated, 75% were type B2/C lesions, 20% were chronic total occlusion lesions, and 24% were bifurcated lesions. The average stent length was 24.6 +/- 11.7 mm. Patients were treated with clopidogrel for one month, and 16 patients received clopidogrel for less than one month. The duration of aspirin administration was indefinite.
“For patients treated with Genous, our typical prescription of dual antiplatelet therapy is 30 days,” said Robbert de Winter, Academic Medical Center, Amsterdam. “In this large, unselected patient population, there was also a segment of patients who were contraindicated to long-term dual antiplatelet therapy and thus received less than 30 days of therapy. For this reason, it was particularly striking there were only two cases of early stent thrombosis and that no thrombosis was observed after one month through the three year follow up, attesting to the excellent safety profile of Genous in a real world setting.”