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| |  TCT: SIRIUS Trial Results Are Extremely Encouraging In Blocked Coronary Arteries By Maggie Schwarz Special to DG News WASHINGTON, DC -- September 26, 2002 -- The investigational Cypher sirolimus-eluting stent could reduce the number of bypass surgeries, as well as the recurrence rate of scarring after angioplasty with stents to approximately 4 percent. This positive result was reported here September 24th at the 14th Annual Transcatheter Cardiovascular Therapeutics symposium by Martin B. Leon, MD, and colleagues, from Lenox Hill Hospital and the Cardiovascular Research Foundation, New York, New York. Eight-month angiographic and nine-month clinical data, as well as 8-month intravascular ultrasound data, were reported. The 1058 SIRIUS patients were randomized to two treatment arms: 533 patients received a sirolimus-eluting stent and 525 a bare metal stent. Eight-month angiographic follow-up showed minimal in-stent late lumen loss (0.17 mm) in patients treated with the sirolimus-eluting stent. The 3.2 percent rate of angiographic in-stent restenosis represents a 91 percent reduction vs the control arm (bare metal stent), and the 8.9 percent angiographic in-lesion restenosis (including a 5-mm area at each end of the stent) represents a 75 percent reduction vs the control arm. These results support the findings of earlier studies, including the 12-month RAVEL study in Europe and Latin America, and the 2-year First-in-Man feasibility study. "We are extremely impressed by the consistency in findings pertaining to the major reductions of in-stent restenosis and the late lumen loss-renarrowing of the artery wall-associated with the sirolimus-eluting stent," said Dr. Leon. "Reduction in late lumen loss is perhaps the most reliable and discriminating indicator cardiologists have to gauge long-term efficacy of this device," he continued. "There was also significantly less late loss on both the proximal and distal sirolimus-eluting stent margins than with the control stent." Dr. Leon described the SIRIUS study as one that has set a standard for drug-eluting stents. "Not only is SIRIUS the largest study of its kind," he said, "but it is also the most comprehensive." Our SIRIUS study reached new levels in terms of high-risk patients and difficult-to-treat lesions." At 9-month follow-up, the event-free survival rate was 92.7 percent in the sirolimus-treated cohort vs 80.7 percent in the bare metal stent cohort (p<.001). There was a 75 percent reduction in the target lesion revascularization rate in the sirolimus-eluting stent group vs the bare metal stent group. Dr. Leon noted the sirolimus-elutiing stent is the only drug-eluting coronary stent whose performance is supported by two large-scale, randomized, double-blind, controlled clinical trials, SIRIUS and RAVEL (Randomized Study with the Sirolimus-Eluting Velocity Balloon-Expandable Stent). RAVEL ended in Spring 2002 and involved 238 patients. Dr. Leon concluded by stating that the results continue to support the excellent performance of the sirolimus-eluting stent.
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