SPIRIT Trial Proves Favorable for Abbott DES
Positive six-month results of Abbott's SPIRIT II clinical trial of the XIENCE V Everolimus Eluting Coronary Stent System were presented at the World Congress of Cardiology conference in Barcelona, Spain. XIENCE V, which has received CE Mark approval, is currently an investigational device in the U.S. and Japan — Abbott says it plans to initiate European launch of the coronary DES in October.
Results of the trial, which was conducted in Europe and Asia Pacific, demonstrated superiority of the XIENCE V stent system compared to the TAXUS paclitaxel-eluting coronary stent system, according to Abbott, with respect to the study's primary endpoint, which was angiographic in-stent late loss at six months (0.11 ± 0.27 mm for XIENCE V vs. 0.36 ± 0.39 mm for TAXUS, p<0.0001). Late loss is a measure of the change in the vessel diameter between the time immediately following stent placement and at six months.
Secondary endpoints of the trial also demonstrated positive results for the XIENCE V stent system, including a statistically significant reduction in percent diameter stenosis from 21 percent for TAXUS to 16 percent for XIENCE V (p<0.001). The in-stent angiographic binary restenosis rate for XIENCE V was 1.3 percent compared to 3.5 percent for the TAXUS control.
For more information contact Karin Bauer Aranaz at (415) 859-3414 or Nicole Osmer at (650) 454-0504, or visit www.abbott.com.