OrbusNeich has announced that three-year clinical results presented at the American College of Cardiology’s (ACC’s) 61st Annual Scientific Session & Expo, ACC.12, demonstrate the safety and feasibility of the Genous stent for patients with ST-segment elevation myocardial infarction (STEMI) and showed no incidence of very late stent thrombosis. Additional analyses from the REMEDEE trial for OrbusNeich’s Combo Dual Therapy Stent were also featured at the congress.
For the study in STEMI patients, the primary endpoint was the rate of major adverse cardiac events (MACE), defined as death, myocardial infarction, target vessel revascularisation and stent thrombosis, between one and three years. The MACE rate at three years was 20.1%, driven predominantly by cardiac death and myocardial infarction; after patients with cardiogenic shock were excluded, the MACE rate was 15.5%. Importantly, no incidence of stent thrombosis was observed between one and three years. The prospective study included 384 STEMI patients treated with the Genous Stent, of which 7.2% had cardiogenic shock and 33.1% had diabetes.
“The absence of stent thrombosis between the first and third years is particularly impressive in this high-risk patient population,” said Huay Cheem, National University Hospital, Singapore, the study’s principal investigator. “The use of drug eluting stents in the setting of primary percutaneous coronary intervention (PCI) has generated some concern in the past, and the Genous stent’s good safety profile despite only one month of dual antiplatelet therapy makes it an attractive alternative in this situation.”
New analyses from the REMEDEE trial were also presented at ACC.12 and compared angiographic and intravascular ultrasound (IVUS) endpoints for the Combo Dual Therapy Stent versus the Taxus Liberté paclitaxel-eluting stent. The data showed qualitative and quantitative differences between the two stents, specifically in the pattern of in-stent late lumen loss at nine months.
“These analyses attest to the clinical differences between the monotherapy approach of drug elution alone and the dual therapy approach of Combo, which combines drug elution with the pro-healing Genous technology,” said Michael Haude, director of Medical Clinic I, Lukaskrankenhaus in Neuss, Germany, and the REMEDEE trial’s principal investigator. “First, we observe a tighter distribution of in-stent late lumen loss for the Combo Dual Therapy Stent versus a bimodal distribution for the Taxus Liberté stent. Second, we see that the restenosis pattern of recurrence for the Combo Dual Therapy Stent is more focal compared to Taxus, which is more diffuse. These results help us to understand the two different approaches more clearly.”
Nine-month clinical outcomes from the REMEDEE study were previously presented at TCT 2011, confirming that the Combo Dual Therapy Stent was non-inferior to the Taxus Liberté stent with respect to in-stent late lumen loss at nine-month angiographic follow-up.