Atrium Medical Corporation today announced the publication of the COBEST Trial by the Journal of Vascular Surgery. COBEST (Covered Versus Balloon Expandable Stent Trial) was an independent, landmark, prospective, multi center, randomized, controlled clinical trial that has demonstrated that Atrium's proprietary balloon expandable covered stent technology is superior to traditional bare metal stents for the treatment of aorto-iliac disease. The journal article, "A comparison of covered vs bare metal stents for the treatment of aorto-iliac occlusive disease" is currently in press and is also available on-line at the publisher's websites, www.elsevier.com or www.sciencedirect.com .
COBEST was the first prospective head-to-head comparison of Atrium's Vascular V12 balloon expandable covered stent versus bare metal stents (BMS) for the treatment of a specific type of Peripheral Arterial Disease (PAD) known as aorto-iliac occlusive disease. The study's principal investigator, Professor Patrice Mwipatayi, M.D., is head of vascular surgery at Royal Perth Hospital in Perth, Australia.
COBEST has demonstrated that in TASC B, C, and D iliac lesions, patients implanted with Atrium's Advanta V12 were more likely to remain free from binary restenosis and had fewer reinterventions than patients with bare metal stents implanted. Upon sub-analysis, Dr. Mwipatayi and the other co-investigators have concluded that Atrium's Vascular V12 demonstrated the greatest benefit in patients with more complex disease (TASC C & D lesions). There were significantly lower restenosis rates, significantly lower target vessel revascularization (TVR) rates, significantly improved ABI's, and, when these more difficult TASC C & D lesions were analyzed, lower occlusion rates were observed at twelve and eighteen months compared to BMS.
In this study, Atrium's Vascular V12 has demonstrated higher long term patency and improved clinical outcomes compared to BMS. COBEST was an independent investigator initiated study; Atrium Medical had no role in the study design, data collection, data interpretation, or writing of the clinical report. Atrium provided funding for the study, including the employment of a research assistant.
Dr. Mwipatayi has provided this statement regarding COBEST: "This was the first prospective, randomized, multi center, controlled trial comparing balloon expandable covered stents directly to bare metal stents. One striking result from the COBEST study was the 5 times lower TVR rate with Atrium's V12 compared to BMS. This poses a tremendous global economic benefit along with a tremendous quality of life benefit for our patients who are being treated for peripheral vascular disease and more specifically aorto-iliac disease."
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