December 18, 2008 - Abbott this week said it started the SPIRIT Small Vessel, a clinical trial evaluating a 2.25mm size of the XIENCE V Everolimus-Eluting Coronary Stent System.
The 2.25mm stent system would offer physicians an option for treating coronary artery disease in narrower vessels that is based on the proven efficacy, safety and deliverability of XIENCE V.
In July 2008, XIENCE V was launched in the U.S., where it quickly became the market-leading drug-eluting stent. The addition of a 2.25mm size would complement the broad range of XIENCE V lengths and diameters. Upon FDA approval of the 2.25mm stent system, the device will be called XIENCE NANO in the U.S. The XIENCE V 2.25mm stent system received CE Mark approval and was launched in various countries in Europe, Asia and Latin America in March 2008.
“Treatment of lesions in small coronary vessels is often complex and associated with higher rates of complications. Being able to deliver a stent accurately to the diseased area of the vessel is crucial for successful treatment,” said Marco Costa, M.D., Ph.D., director of invasive services, and director of the Center for Research and Innovation, Harrington-McLaughlin Heart and Vascular Institute, University Hospitals, Case Western Reserve University, and principal investigator of the SPIRIT Small Vessel trial. “Given the strong clinical performance and ease of use of XIENCE V, a smaller stent system would significantly enhance the treatment options for patients with coronary artery disease in small vessels.”
The SPIRIT Small Vessel trial is designed to study 250 patients at about 50 centers in the U.S. The primary endpoint is a composite measure of cardiac death, heart attack (target vessel myocardial infarction) and target lesion revascularization (repeat procedures on the treated vessel) at one year.
Observational data supporting the safety and efficacy of XIENCE V in the treatment of coronary artery disease in small vessels was presented at the 2008 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in October. James B. Hermiller, M.D., director, cardiac catheterization labs, The Care Group at St. Vincent Hospital in Indianapolis, and an investigator of the SPIRIT III trial, presented subgroup data from the SPIRIT III trial comparing XIENCE V to the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS) in patients with small vessels. In this subgroup analysis, patients were treated with a 2.5mm stent system and had an average reference vessel diameter of 2.36mm.
"In the SPIRIT III subgroup analysis, XIENCE V performed extremely well in small vessels. Compared to TAXUS, XIENCE V reduced in-stent late loss, or vessel re-narrowing, by 80 percent eight months after the procedure, and reduced major adverse cardiac events by 74 percent at nine months," said Dr. Hermiller. "When you consider these trends, the availability of a smaller XIENCE V stent system specifically designed to treat lesions in small vessels has the potential to significantly improve patient care."
The SPIRIT III small vessel subgroup analysis demonstrated an 80 percent reduction in in-stent late loss compared to TAXUS at eight months. There was an observed 74 percent reduction in major adverse cardiac events (MACE) compared to TAXUS at nine months. There was also an observed 68 percent reduction in the risk of target vessel failure and a 90 percent reduction in target lesion revascularization (TLR) compared to TAXUS at nine months.
For more information: www.abbott.com