Health Canada Approves Abbott's XIENCE V(R) Drug Elu...(enior vice president vascular Abbott. W...),Health

Outstanding Clinical Evidence for XIENCE V

The clinical program for XIENCE V studied patients in the United States, Canada, Europe, South Africa and Asia-Pacific, and demonstrated excellent long-term results and data on "real-world" patients from the SPIRIT family of trials.

In long-term data from the SPIRIT III** trial of 1,002 patients, XIENCE V continued to demonstrate positive clinical benefits for patients out to two years. XIENCE V demonstrated a 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS)* at two years. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, and is defined as a composite of cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (ID-TLR driven by lack of blood supply) for the SPIRIT III trial. XIENCE V also demonstrated a low rate of stent thrombosis between one and two years per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.3 percent for XIENCE V vs. 1.0 percent for TAXUS). The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.

In March 2009, Abbott presented long-term data from the SPIRIT II*** clinical trial of 300 patients, which showed that patients treated with XIENCE V continue to experience fewer heart attacks, deaths or repeat procedures at the target lesion compared to patients treated with TAXUS out to three years. XIENCE V demonstrated a 57 percent reduction in the risk of MACE compared to TAXUS at three years (6.4 percent for XIENCE V vs. 14.9 percent for TAXUS)*. For t
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