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Abbott's XIENCE V(R) Demonstrates Impressive Low Rates of Repeat Procedure, Stent Thrombosis and Major Adverse Cardiac Events in Complex, 'Real World' Patients in SPIRIT V Study
Date:5/21/2009

Safety and Efficacy Rates in Patients with Challenging Anatomy Consistent with Superior Results from Randomized Clinical Trials

BARCELONA, Spain, May 21 /PRNewswire-FirstCall/ -- New data presented today at EuroPCR from an international, post-approval, single-arm study show that Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System demonstrated low rates of repeat procedure (target lesion revascularization), stent thrombosis and major adverse cardiac events (MACE) in a complex patient population. In the SPIRIT V (five) study, XIENCE V (vee) demonstrated a very low 1.8 percent rate of target lesion revascularization (TLR), a 0.7 percent rate of stent thrombosis and a 5.1 percent rate of MACE at one year. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction attributed to the target vessel), and TLR driven by lack of blood supply. The SPIRIT V study evaluated XIENCE V in a diverse, "real world" population of patients and lesion types, including diabetics, patients with multi-vessel disease and patients with highly complex lesions.

"The data from real-world studies are valuable because they reflect a broad patient population that is more representative of the spectrum of disease seen in a typical interventional cardiology practice," said Eberhard Grube, M.D., chief, Department of Cardiology and Angiology, Heart Center Sieburg in Germany and principal investigator of the SPIRIT V study. "The one-year results from SPIRIT V indicate that even in a patient population with a high percentage of complex lesions, XIENCE V exhibits remarkably low event rates, similar to what was seen when XIENCE V was studied in controlled, randomized SPIRIT studies."

SPIRIT V is an international, post-approval study of 2,663 patients. Approximately 100 clinical sites throughout Europe, Asia-Pacific and Canada are
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