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"XIENCE V is an important innovation that gives patients in the UnitedStates access to a next-generation drug eluting stent that has been shown inclinical trials to improve patient outcomes," said Dr. Jones. "During thestent procedure, we found it easy to deliver XIENCE V to the diseased portionof the vessel. With its combination of clinical efficacy and deliverability,I believe that XIENCE V will become a key advancement in the treatment ofcoronary artery disease."
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The XIENCE V USA study is designed to evaluate at least 5,000 coronaryartery disease patients treated with the XIENCE V drug eluting stent atapproximately 250 centers across the United States. The primary endpoint ofXIENCE V USA is a measure of stent thrombosis (formation of blood clots) everyyear out to five years, as defined by the Dublin/Academic Research Consortium(ARC). The ARC definition of late stent thrombosis was developed to eliminatevariability in the definitions across various drug eluting stent trials.
The co-primary endpoint of the study is the composite rate of cardiacdeath and any heart attack (Q-wave or non-Q-wave myocardial infarction) inpatients at one year. Secondary endpoints of the study include patientcompliance with prescribed anti-platelet medication, measures of re-treatmentby stenting or surgery, and device and procedural success.
"Post-approval studies allow physicians to follow the safety and efficacyof new treatments in a more complex patient population than is typicallystudied in pre-approval clinical trials. XIENCE V USA will providesignificant insight about the performance of Abbott's new drug eluting stentin a variety of patients," said Charles Simonton, M.D., FACC, FSCAI,divisional vice president, Medical Affairs and chief medical officer, AbbottVascular. "Our ability to work with our physician partners to begin thispost-approval study within days of FDA approval is further evidence ofAbbott's commitment to help the interventional cardiology community gainadditional insights about the clinical benefits of XIENCE V."
About XIENCE V
XIENCE V is used to treat coronary artery disease by propping open anarrowed or blocked artery and releasing the drug, everolimus, in a controlledmanner to prevent the artery from becoming blocked again following a stentprocedure. XIENCE V is built upon Abbott's market-leading bare metal stent,the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform isdesigned to facilitate ease of delivery, making it easier for physicians tomaneuver the stent and treat the diseased portion of the artery.
Long-term results with XIENCE V in the SPIRIT III pivotal U.S. clinicaltrial demonstrated a 45 percent reduction in the risk of major adverse cardiacevents (MACE) compared to the TAXUS(R) paclitaxel-eluting coronary stentsystem at two years. XIENCE V demonstrated a 32 percent reduction in targetvessel failure (TVF, cardiac events related to the stented vessel) compared toTAXUS at two years. XIENCE V also demonstrated a low rate of stent thrombosisbetween one and two years, defined as very late stent thrombosis, per AcademicResearch Consortium (ARC) definition of definite/probable stent thrombosis(0.3 percent for XIENCE V and 1.0 percent for TAXUS). XIENCE
