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Results show similar outcomes for Genous and Taxus
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Results show similar outcomes for Genous and Taxus
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SIX MONTH clinical results from the TRIAS HR pilot study have revealed that the Genous endothelial progenitor cell capturing stent (OrbusNeich) has similar outcomes for treating high risk restenosis lesions compared to the Taxus paclitaxel eluting stent (Boston Scientific). Dr Robbert J de Winter, Academic Medical Center, University of Amsterdam, The Netherlands, presented the data at the recent Transcatheter Cardiovascular Therapeutics (TCT) meeting, held in Washington, DC. He began by explaining the primary differences between the Taxus and Genous stents. He said that drug-eluting stents (DES) “..inhibit smooth muscle cell growth and intimal hyperlasia, but at the same time endothelialisation of the stent struts.” In comparison, he explained that “Genous endothelial progenitor cell capturing technology, instead of inhibiting cell growth, enhances endothelialisation.” As a result, the Genous technology accelerates healing, protects against thrombus, minimises restenosis and has an improved safety profile over current DES.
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Study design The TRIAS HR pilot study is comparing the feasibility and efficacy of the Genous EPC-attracting stent with the Taxus paclitaxel-eluting stent in the treatment of coronary artery stenosis in patients/lesions with high risk of restenosis. The primary endpoint is cardiac death, myocardial infarction (MI) and repeat revascularisation of the treated vessel, at one year. The main long-term endpoint at five years is death or MI. Secondary endpoints include procedural success, defined as a less than 20% residual stenosis and TIMI 3 flow post percutaneous coronary intervention (PCI). Within one to five years, the secondary endpoints are target vessel failure, target lesion failure, target vessel revascularisation, target lesion revascularisation and hospitalisation for acute coronary syndrome. De Winter reported that there is restricted use in selected patients with high risk of restenosis, and defined high risk patients as having the following characteristics: - Lesions ≥23mm in length
- Lesions in vessels ≤2.8mm in diameter
- Any lesions in diabetic patients
- Lesions defined as chronic total occlusion (CTO)
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The pilot study is a single-centre, prospective, randomised, single-blind study involving 193 patients who were recruited from February 2006 to April 2007. Clinically stable patients undergoing a PCI for a native, de novo, coronary artery lesion(s) with a high risk of restenosis were included in the study. Dual anti-platelet therapy was administered for at least one month for Genous patients and a minimum of six months for Taxus patients. The primary exclusion criteria included patients with stent thrombus elevation myocardial infarction and current unstable arrhythmias. Patients who were the recipient of a heart transplant or any other organ transplant were also excluded, along with those scheduled to receive chemotherapy or radiation therapy within 30 days prior or after the procedure. Also excluded were patients who have planned elective surgery within the first six months after the procedure that will require discontinuing either aspirin or clopidogrel. de Winter reported that clinical followup was carried out after 30 days and six months. Clinical follow-up is also planned at 12 months and yearly to five years. A total of 98 patients received a Genous stent and 95 patients were treated with the Taxus stent. The average age of patients was 62 and 63 years, respectively. Stable angina occurred in 82% of Genous patients and 85% of Taxus patients, and previous MI, PCI and coronary artery bypass graft (CABG) occurred in 38%, 26% and 3% of Genous patients and 41%, 26% and 3% of Taxus patients, respectively. 121 lesions were treated in the Genous group and 125 lesions in the Taxus group. Chronic total occlusions occurred in 32% of Genous patients and 24% of Taxus patients. Type B2 and C lesions totalled 92% in the Genous arm and 84% in the Taxus patients. Lesion length was 26.8mm and 25.4mm in the Genous and Taxus groups, respectively. Reference vessel diameter was the same at 3.2mm. At six months, there was not a statistically significant difference in target vessel failure with 8.4% occurring in the Genous group and 5.4% in the Taxus group. 11 patients (11.6%) in the Genous arm returned for a revascularization while 18 Taxus patients (19.6%) were retreated.
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Conclusions In his concluding remarks, de Winter said that, “There were similar clinical outcomes at six months but with most Genous patients on dual antiplatelet therapy for one month while the majority of Taxus patients remained on dual antiplatelet therapy at six months.” He added that a large multi-centre study is currently underway. Furthermore, there were three angiographically documented stent thrombosis events in the Taxus group occurring at 24 hours, 10 days, and 155 days all resulting in both a myocardial infarction and a target lesion revascularization (TLR). While there was one thrombosis event in the Genous arm occurring in hospital at 6 hours post procedure resulting in a TLR.
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