Abbott Begins Post-Approval Study of XIENCE V(TM) Drug Elu...( XIENCE V USA Study to Evaluate Tr...)

XIENCE V USA Study to Evaluate Treatment of Coronary Artery Disease

Patients in Real-World Setting

ABBOTT PARK, Ill., July 9 /PRNewswire-FirstCall/ -- Abbott today announced the start of the XIENCE V(TM) USA post-approval study, with six hospital centers already recruiting and enrolling patients just one week after the U.S. Food and Drug Administration approved the XIENCE V(TM) Everolimus Eluting Coronary Stent System. The XIENCE V USA study will evaluate the safety and effectiveness of the XIENCE V drug eluting stent in a real-world clinical setting out to five years. Jack Jones, M.D., interventional cardiologist and medical director of the Stormont-Vail Catheterization Lab in Topeka, Kan., was one of the first physicians to enroll a patient into the study.

"XIENCE V is an important innovation that gives patients in the United States access to a next-generation drug eluting stent that has been shown in clinical trials to improve patient outcomes," said Dr. Jones. "During the stent procedure, we found it easy to deliver XIENCE V to the diseased portion of the vessel. With its combination of clinical efficacy and deliverability, I believe that XIENCE V will become a key advancement in the treatment of coronary artery disease."

The XIENCE V USA study is designed to evaluate at least 5,000 coronary artery disease patients treated with the XIENCE V drug eluting stent at approximately 250 centers across the United States. The primary endpoint of XIENCE V USA is a measure of stent thrombosis (formation of blood clots) every year out to five years, as defined by the Dublin/Academic Research Consortium (ARC). The ARC definition of late stent thrombosis was developed to eliminate variability in the definitions across various drug eluting stent trials.

The co-primary endpoint of the study is the composite rate of cardiac death and any heart attack (Q-wave or non-Q-wave myocardial infarction) in patients at one year.
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