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Abbott Announces Approval in China for Next-Generation XIENCE V(R) Drug Eluting Stent
Date:9/14/2009

R compared to TAXUS (4.1 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value=0.03)**, and a 41 percent reduction in the risk of cardiac death or heart attack (MI) compared to TAXUS (3.8 percent for XIENCE V vs. 6.3 percent for TAXUS, p-value=0.04)**.

In March 2009 at the American College of Cardiology annual meeting, 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, p-value=0.029)**.

In addition, there was no occurrence of stent thrombosis between two and three years with XIENCE V, and a low rate of stent thrombosis from zero to three years, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.9 percent for XIENCE V and 2.8 percent for TAXUS, p-value=0.27)** in the SPIRIT II trial. The ARC definitions of stent thrombosis were developed to eliminate variability in the definitions across various drug eluting stent trials.

In May 2009 at EuroPCR, Abbott presented one-year data from the SPIRIT V (five) international, single-arm study, which evaluated XIENCE V in 2,663 patients - including more than 60 patients enrolled at two sites in China. XIENCE V demonstrated low rates of repeat procedure (target lesion revascularization or TLR), stent thrombosis and MACE in a diverse, "real world" population of patients and lesion types, including patients with diabetes, patients with multi-vessel disease and patients with highly complex lesions. In the SPIRIT V study, XIENCE V demonstrated a very low 1.8 percent rate of TLR, a 0.7 percent rate of definite/probable stent thrombosis and a 5.1 percent rate
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SOURCE Abbott
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