Lenox Hill Heart and Vascular Institute of New York cardiologists, the lead investigators in the nationwide SIRIUS study testing the effectiveness of a new, drug-eluting stent in the treatment of clogged arteries, today announced the results of the nine-month clinical data.
The cardiologists revealed that stents coated with the immuno-suppressive drug sirolimus led to a 75% reduction in restenosis. Only 4.1% of patients who were given the drug-eluted stents required a new procedure to reopen the treated vessels compared with nearly 17% who were given a conventional, bare metal stent.
The SIRIUS study, which followed 1, 058 patients in 53 medical centers across the country, was performed to determine whether coating the stent with sirolimus would prevent restenosis, a process in which the arteries at the site of the stent begin to close again due to the growth of scar tissue.
"These results confirm that drug-coated stents show great promise for the treatment of clogged arteries. This pivotal clinical trial will transform the way patients with coronary artery disease are treated," said Jeffrey W. Moses, MD, Chief of Interventional Cardiology at Lenox Hill Hospital and Co-Principal Investigator.
Each year, over 750,000 Americans undergo balloon angioplasty, a minimally invasive procedure to open one or more clogged arteries. More than 75 percent of these cases include the insertion of a stent - a tiny stainless steel device about the size of a ballpoint pen spring that helps to prop open the arteries to reduce the likelihood of restenosis. However, scarring and recurring blockages occur in approximately 15 to 20 percent of patients with stents.
"Clinical trial results suggest drug-eluting stents dramatically improve the outcome of the most common side effect of the procedure - the artery renarrowing again. I believe these results will lead to quick FDA approval and a new era where arteries seldom close up again," said Martin B. Leon, MD, CEO of the Cardiovascular Research Foundation, Lenox Hill Heart and Vascular Institute's research arm and Co-Principal investigator of the SIRIUS study.
The Lenox Hill Heart and Vascular Institute of New York offers a comprehensive approach to total cardiac and vascular care, providing diagnosis and treatment of simple and complex conditions, as well as rehabilitation and disease prevention. Care is provided by Lenox Hill Hospital's internationally renowned team of specialists in cardiology, cardiothoracic surgery, endovascular surgery and vascular surgery.
Members of the press seeking information about Lenox Hill Hospital should call the Public Relations Department at (212) 434-2400.