October 22, 2007 – Stent thrombosis rates through one year were low for both the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (0.6 percent, 0.6 percent) and the XIENCE V (PROMUS) Everolimus Eluting Coronary Stent System. (0.8 percent, 1.1 percent), according to results from the SPIRIT III Clinical Trial announced Boston Scientific at TCT 2007.
Analysis of the data was presented by Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation in New York, and the Principal Investigator of the SPIRIT III Trial.
One-year results from the SPIRIT III trial included an updated analysis of 1,002 patients with coronary artery disease treated with either the XIENCE V (PROMUS) Stent or the TAXUS Express Stent. Ischemia–driven target lesion revascularization (TLR) for 669 patients treated with the XIENCE V (PROMUS) Stent changed from 2.6 percent to 3.3 percent between nine months and one year, while for the 333 patients treated with the TAXUS Stent, TLR changed from 5.0 percent to 5.6 percent during the same time period, still failing to reach statistical significance (p=0.09). Target vessel revascularization (TVR) at one year was also similar, with 6.1 percent for PROMUS and 7.5 percent for TAXUS (p=0.41).
The overall MACE (Major Adverse Cardiac Events) rate (defined as cardiac death, myocardial infarction (heart attack, or MI) or ischemia-driven TLR) through one year was 5.8 percent for the XIENCE V (PROMUS) Stent and 9.9 percent for the TAXUS Stent (p=0.01), reflecting an increased number of small (non-Q wave) MIs at the time of the procedure (2.5 percent vs. 3.8 percent).
Subset analysis showed strong performance of the TAXUS Stent in diabetic patients with MACE rates remaining low at 4.7 percent, while MACE rates increased in the XIENCE V (PROMUS) Stent to 8.8 percent. In long lesions (lesion length>13.2 mm), MACE was 7.7 percent for the XIENCE V (PROMUS) Stent and 8.0 percent for the TAXUS Stent; in small vessels (RVD≤2 .775 mm), 6.1 percent for the XIENCE V (PROMUS) Stent and 12.1 percent for the TAXUS Stent.
SPIRIT is sponsored by Abbott. TAXUS, Express2 and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.
For more information: www.bostonscientific.com