Cath Lab Digest - December 2007 - (Page 43) 43 noninvasive method to exclude obstructive coronary blockages. Sixteen institutions performed CCTA on 232 patients with typical or atypical chest pain prior to invasive coronary angiography. Findings were then compared to those of QCA, the reference standard used to quantify the results of the invasive coronary angiography. A total of 82 blockages greater than 50 percent in 49 patients and 31 blockages greater than 70 percent were detected in 28 patients by QCA. Per-patient sensitivity and specificity of CCTA were 93 percent and 82 percent, respectively, for blockages greater than 50 percent, and 91 percent and 84 percent for blockages greater than 70 percent. In addition, negative predictive value was 97 to 99 percent. “In a population of chest pain patients with a low to intermediate prevalence of obstructive coronary artery blockages, CCTA performed highly accurately compared to invasive coronary angiography,” said presenter James K. Min, MD, assistant professor of radiology and medicine at New York Presbyterian Hospital and director of the Cardiac Computed Tomography Laboratory and Cornell University Medical Center. ■ Computed Tomography Angiography cont. invasive angiography in its ability to identify patients to be referred for angioplasty or bypass surgery. “Reliable assessment of the presence of coronary blockages and accurate prediction of coronary revascularizations are feasible with 64-slice CT coronary angiography,” said presenter Marc Dewey, MD, radiologist at Humboldt University Berlin, Charite, Germany. “Patients with low to intermediate risk of having coronary blockages are most likely to benefit from coronary CT angiography, since in those patients the necessity of invasive angiography is greatly reduced.” The Assessment by Coronary Computed Tomographic Angiography of Individuals UndeRgoing InvAsive Coronary AngiographY (ACCURACY) Trial compared 64-row coronary computed tomographic angiography (CCTA) to quantitative coronary angiography (QCA). The results demonstrated that CCTA is highly accurate in detecting coronary blockages in chest pain patients referred for invasive coronary angiography and is also an effective Comprehensive Safety and Efficacy Data on Xience™ V Drug-Eluting Stent Presented by Abbott to FDA Advisory Committee on Nov. 29 New Data Released Confirms Consistency of Results for Late Loss, TVF, MACE, TLR, Cardiac Death, MI, Thrombosis Across all Xience V Studies A bbott released a summary of clinical highlights on the Xience™ V Everolimus Eluting Coronary Stent System, presented Nov. 29 to the Circulatory System Devices Advisory Panel, an advisory committee to the U.S. Food and Drug Administration (FDA). The clinical summary was released in conjunction with the posting of the Panel briefing documents on the FDA web site (http://www.fda.gov). The advisory panel will review the data and recommend if the FDA should approve Xience V, a next-generation drug eluting stent for the treatment of coronary artery disease. Data made available as part of the Panel documents include two-year safety results from a pooled subset of 603 patients from the SPIRIT II and SPIRIT III trials (422 treated with XIENCE V). Results from this subset are consistent with the positive SPIRIT III one-year data and the pooled analysis of the SPIRIT II and SPIRIT III trials at one year presented at TCT 2007. The new two-year subset data analysis shows similar low rates of major adverse cardiac events (MACE), target vessel failure (TVF), cardiac death, heart attack, and stent thrombosis as previously reported in the SPIRIT trials. The pooled two-year subset data also show similar rates of death, myocardial infarction (MI), and late stent thrombosis (31758 days) between Xience V and the Taxus® Paclitaxel-Eluting Coronary Stent System at two years. “Across all of the SPIRIT trials, XIENCE V has met its primary and major secondary endpoints, demonstrating either noninferiority or clinical superiority compared to TAXUS, the most widely used drug eluting stent,” said Gregg W. Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, principal investigator of the SPIRIT III clinical trial. “The data out to two years also demonstrate XIENCE V is safe, with low rates of death, heart attack and stent thrombosis, which were comparable to TAXUS, with improved efficacy in terms of freedom from clinical restenosis.” Abbott’s continued access and postapproval program is projected to enroll more than 14,000 Xience V patients across a variety of planned clinical trials. Abbott also outlined plans for its XIENCE V USA trial, a 5,000 patient post-approval trial designed to study safety outcomes such as late stent thrombosis, death, MI and revascularization with follow-up out to five years. The study also will evaluate patient compliance with antiplatelet therapy. In addition to XIENCE V USA, SPIRIT IV is a 3,690-patient continued access trial that is currently enrolling patients and will evaluate the safety and efficacy of Xience V for the treatment of coronary artery disease in a more complex patient population in the United States. SPIRIT V is an international clinical trial that will provide additional clinical experience with Xience V in approximately 3,000 patients at approximately 100 clinical sites throughout Europe, Asia, Canada and Latin America. XIENCE V SPIRIT WOMEN is the world’s first drugeluting stent trial to study only women and will evaluate the characteristics of 2,000 women undergoing stent implantation as well as the performance of Xience V in those patients in Europe, Asia-Pacific, Canada and Latin America. Both SPIRIT V and XIENCE V SPIRIT WOMEN are currently enrolling patients. Abbott filed its Premarket Approval (PMA) submission for Xience V with the FDA on June 1, 2007. Xience V was launched in Europe and other international markets in 2006. Xience V is currently an investigational device in the United States and Japan. ■ Barry T. Katzen, MD, honored with Career Achievement Award B arry T. Katzen, MD, founder and course director of the International Symposium on Endovascular Therapy (ISET, January 20-24, 2008, www.iset.org), received the prestigious Career Achievement Award of the 2007 Transcatheter Therapeutics Conference (TCT) in Washington, D.C. An interventional radiologist, Dr. Katzen, 61, was honored for his pioneering development of angioplasty for vessels outside the heart. Dr. Katzen performed the first “peripheral” angioplasty in the United States in 1978 by using a balloon mounted on a catheter to open a blocked artery. Dr. Katzen is the founder and medical director of Baptist Cardiac & Vascular Institute in Miami, Florida. He graduated from the University of Miami School of Medicine and completed his residency at the New York HospitalCornell Medical Center. ■ http://www.fda.gov http://www.iset.org
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