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| |  ISET: Sirolimus-Coated Nitinol Stent Prevents Restenosis in Peripheral Artery Disease By Ed Susman Special to DG News MIAMI BEACH, FL -- January 23, 2002 -- Use of sirolimus-eluting self-expanding stents appears to prevent restenosis and in-stent restenosis in patients with peripheral artery disease, according to results of an international study. "The astonishingly good performance of these stents shows that we have achieved proof-of-principle," said Stephen Duda, MD, professor of radiology at the University of Tuebingen, in Germany, who presented the findings here yesterday at the annual International Symposium on Endovascular Therapy. For their study, Dr. Duda and colleagues enrolled 36 patients in six institutions in Germany, France, the Netherlands and Canada, and randomised them to treatment with the Cordis SMARTTM stent with a coating of the anti-rejection drug sirolimus or an uncoated version of the nitinol stent. SMART refers to Shape Memory Alloy Recoverable Technology. Mean stent diameter, measured after six months of treatment, was 4.95 mm for patients receiving the coated Cordis SMART stent compared with a mean stent diameter of 4.31 mm for patients who received the uncoated stent. That difference reached statistical significance to the p=0.047 level. The study also found a 23-percent restenosis rate -- including regions of the artery beyond where stenting occurred -- among patients receiving the uncoated device, compared with zero percent restenosis with the coated stent. There was also a 17.6 percent rate of in-stent restenosis with the coated stent, compared with zero percent among the coated stent patients. The uncoated stent group achieved complete re-occlusion, while there was no re-occlusion in the sirolimus-coated stent group. A 0.8 mm late loss in patients treated with the uncoated stent, compared with 0.5 mm in the sirolimus group, which represents a decrease of 40 percent in re-growth of tissue in the angioplasty-expanded lumen. Dr. Duda said the unexpectedly good results obtained with the uncoated stent -- a 40 to 60 percent restenosis was expected -- prevented most of the end points in the study from reaching statistical significance. However, Michael Jaff, MD, director of vascular medicine at the Heart and Vascular Institute of Morristown, in Morristown, New Jersey, said he expected that when larger numbers are added to the trial, most of the differences would prove significant. Dr. Jaff said that presently he and other interventional radiologists tend to pass peripheral artery disease patients to surgeons. "Right now we don’t offer these patients this type of angioplasty procedure," he said, adding that these results are very exciting, because, if confirmed, they have the potential to change the approach to treatment of patients with the condition. Dennis Donohue, MD, vice president for clinical research for Cordis, in Warren, New Jersey, said that based on the preliminary results reported by Dr. Duda, the company would soon launch a pivotal study aimed at getting the coated stent approved for treatment of atherosclerosis in the legs. The sirolimus-coated stent has also showed similar success when used in coronary arteries, according to results reported last year in Stockholm, Sweden, Dr. Donohue said. Cordis also began studies using the sirolimus-coated stent in patients with renal disease and has plans for using the coated stent for treating diseases in the carotid arteries, he added.
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