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"XIENCE V represents an important treatment advance for the estimated 13million people in the United States suffering from coronary artery disease,and we believe XIENCE V will quickly become the new standard for drug elutingstents given its outstanding clinical results," said John M. Capek, Ph.D.,executive vice president, Medical Devices, Abbott. "Physicians in the UnitedStates have been waiting for years to treat their patients with a technologythat delivers on the promise of drug eluting stents through both ease of useand excellent clinical performance, and XIENCE V is that technology."
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The XIENCE V drug coated stent is used to treat coronary artery disease bypropping open a narrowed or blocked artery and releasing the drug, everolimus,in a controlled manner to prevent the artery from becoming blocked againfollowing a stent procedure. Coronary artery disease occurs when plaque build-up narrows the arteries and reduces blood flow to the heart, which can lead tochest pain or a heart attack.
"XIENCE V was designed to improve safety and efficacy compared to earliergeneration stents. The long-term clinical data from two studies performed inboth the United States and Europe have now confirmed that XIENCE V is a truenext-generation drug eluting stent with clinically important benefits forpatients," said Gregg W. Stone, M.D., Columbia University Medical Center;chairman, Cardiovascular Research Foundation, New York; and principalinvestigator of the SPIRIT III U.S. pivotal clinical trial for XIENCE V.
Clinical Data Supporting XIENCE V
The robust clinical program for XIENCE V includes long-term data from atotal of 1,362 patients enrolled in the SPIRIT FIRST, SPIRIT II and SPIRIT IIItrials, as well as continued access and post-approval programs that willenroll more than 14,000 XIENCE V patients.
The FDA approved XIENCE V based, in large part, on superior results fromthe 1,002 patient SPIRIT III U.S. pivotal clinical trial, in which XIENCE Vdemonstrated statistical superiority to TAXUS on the study's primary endpointof in-segment late loss (vessel renarrowing) at eight months, with astatistically significant 50 percent reduction (mean, 0.14 mm for XIENCE V vs.0.28 mm for TAXUS). XIENCE V also demonstrated statistical non-inferiority toTAXUS in the co-primary endpoint of target vessel failure (TVF, cardiac eventsrelated to the stented vessel) at nine months, with an observed 20 percentreduction (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS). TVF is acomposite clinical measure of safety and efficacy outcomes defined as cardiacdeath, heart attack (myocardial infarction or MI) or target vesselrevascularization (TVR).
In May 2008, Abbott presented two-year data from the SPIRIT III trialdemonstrating that XIENCE V continues to deliver positive clinical benefitsfor patients. At two years, the XIENCE V demonstrated the following keyresults:
-- 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,p-value=0.004)*. MACE is an important composite clinical measure of safety andefficacy outcomes for patients, defined as cardiac death, heart attack (MI) orischemia-driven target lesion revascularization (TLR, repeat procedures drivenby lack of blood supply).
-- A 32 percent reduction in the risk of TVF compared to TAXUS (10.7percent for XIENCE V vs. 15.4 percent for TAXU
