Atrium Medical Corporation (Hudson, NH) announced that Principal Investigator Prof. Bibombe Patrice Mwipatayi, MMed (Surg), published results from the COBEST (Covered Versus Balloon-Expandable Stent Trial) trial online ahead of print in the Journal of Vascular Surgery.
The preliminary 18-month results for the COBEST study were first presented by Professor Mwipatayi at the Vascular Interventional Advances meeting in Las Vegas, Nevada, in October 2009, as reported by Endovascular Today.
COBEST was a prospective, multicenter, randomized controlled clinical trial that compared Atrium’s Advanta Vascular V12 balloon-expandable covered stent to bare-metal stents (BMS) for the treatment of aortoiliac disease.
The COBEST study found that the Advanta V12 stent resulted in higher long-term patency and improved clinical outcomes compared to BMS for the treatment of aortoiliac disease. 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 BMS implanted.
In a subanalysis, the investigators concluded that Atrium’s Advanta V12 stent demonstrated the greatest benefit in patients with more complex disease (TASC C and D lesions). There were significantly lower restenosis and target vessel revascularization (TVR) rates and significantly improved ankle brachial indices. When these more difficult TASC C and D lesions were analyzed, lower occlusion rates were observed at 12 and 18 months compared to BMS.
“This was the first prospective, randomized, multicenter, controlled trial comparing balloon expandable covered stents directly to bare-metal stents,” commented Professor Mwipatayi. “One striking result from the COBEST study was the five-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 aortoiliac disease.”
Atrium noted the company provided funding for the study but that COBEST was an independent investigator-initiated study and that the company had no role in the study design, data collection, data interpretation, or writing of the clinical report.
According to the company, the Advanta V12 device is a low-profile, premounted, covered stent made of a radial, expandable stainless steel. Atrium’s one-piece covering technology creates a thermoconformable microporous polytetrafluoroethylene layer that completely encapsulates the stent. In Europe, the device received CE Mark approval for restoring the patency of iliac and renal vessels and is available in diameters of 5 to 16 mm. It is not available in the United States, the company advised.