Abbott's XIENCE V(R) Superior to TAXUS(R) in Key Safety and Efficacy Measures in SPIRI...(stent thrombosis compared to TAXUS (0.17...),Health

Date:9/23/2009

stent thrombosis compared to TAXUS (0.17 percent for XIENCE V vs. 0.85 percent for TAXUS, p-value=0.004) at one year. Per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis, XIENCE V demonstrated an observed 74 percent reduction in ARC definite/probable stent thrombosis at one year (0.29 percent for XIENCE V and 1.10 percent for TAXUS, p-value=0.004). The ARC definitions of stent thrombosis were developed to harmonize the definition of stent thrombosis across various drug eluting stent trials.

"SPIRIT IV represents one of the largest randomized trials of two drug eluting stents completed to date. Importantly, this study was performed without routine angiographic follow-up, which may result in a tendency to treat lesions which may not be causing symptoms, and potentially impact results," said Dr. Stone, who is also immediate past chairman of the Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT IV trial. "The SPIRIT IV results show that XIENCE V significantly reduces a patient's risk of experiencing a heart attack, the need for a repeat procedure or stent thrombosis."

Event Rates in Complex Patients

The SPIRIT IV trial included multiple complex patient subgroups, including more than 1,100 patients with diabetes, who typically are sicker and have more challenging artery disease. In patients with diabetes, there was no difference in TLF between XIENCE V and TAXUS at one year (6.4 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.80). In patients without diabetes, XIENCE V demonstrated a 54 percent reduction in TLF compared to TAXUS at one year (3.1 percent for XIENCE V vs. 6.7 percent for TAXUS, p-value<0.0001). In the endpoint of ARC definite/probable stent thrombosis, XIENCE V demonstrated a 40 percent reduction compared to TAXUS in patients with diabetes (0.80 percent for XIENCE V vs. 1.33 percent for TAXUS, p-value=0.
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