Healthcare Industry News: thrombosis
News Release - September 23, 2010
Abbott's XIENCE V(R) Shows Continued Strong Performance in Key Safety and Efficacy Measures at Two Years in Investigator-Initiated COMPARE TrialTwo-Year Results from Independent 'All-Comers' Study of 1,800 Real-World Patients Compared XIENCE V to the Newer-Generation TAXUS® Liberte®
Data Show that the Differences in the Two Stents Increase at Two Years
In the Study, Patients Receiving XIENCE V Had a 77 Percent Lower Rate of Stent thrombosis (Blood Clot) than TAXUS Liberte at Two Years
ABBOTT PARK, Ill., Sept. 23 (Healthcare Sales & Marketing Network) -- Late-breaking data were presented today from the investigator-initiated COMPARE trial of 1,800 real-world patients involving Abbott's (NYSE:ABT ) market-leading XIENCE V® Everolimus Eluting Coronary Stent System and the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System (TAXUS). The results from COMPARE at two years were presented by Peter Smits, M.D., of Maasstad Ziekenhuis, Rotterdam, the Netherlands, during the Cardiovascular Research Foundation's 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.
For the endpoint of major adverse cardiac events (MACE) at two years, which is a composite of all death, non-fatal heart attack (myocardial infarction or MI) and target vessel revascularization (TVR), XIENCE V showed a 34 percent lower incidence of MACE compared to TAXUS (9.0 percent for XIENCE V vs. 13.7 percent for TAXUS, p-value=0.0016). The composite secondary endpoint of cardiac death, non-fatal MI and target lesion revascularization (TLR) resulted in a 35 percent lower incidence for XIENCE V compared to TAXUS (7.4 percent for XIENCE V vs. 11.4 percent for TAXUS, p-value=0.0038).
In addition, XIENCE V demonstrated a 77 percent lower rate of stent thrombosis, defined as definite or probable according to ARC (0.9 percent for XIENCE V vs. 3.9 percent for TAXUS, p-value=<0.0001); a 60 percent lower rate of TVR (3.1 percent for XIENCE V vs. 7.7 percent for TAXUS, p-value=<0.0001); a 56 percent lower rate of TLR (2.6 percent XIENCE V vs. 5.9 percent TAXUS, p-value=0.0005); and a 49 percent lower rate of non-fatal MI (3.9 percent XIENCE V for vs. 7.6 percent for TAXUS, p-value=0.0009).
The stent thrombosis rate for XIENCE V between one and two years increased from 0.7 percent at one year to 0.9 percent at two years, while the TAXUS arm increased from 2.6 percent at one year to 3.9 percent at two years. At two years, 88.6 percent of XIENCE V patients and 84.8 percent of TAXUS patients had discontinued dual-antiplatelet therapy.
"The COMPARE results show that the gap in stent thrombosis rates between XIENCE V and TAXUS Liberte widened from 1.9 percent at one year to 3.0 percent at two years," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The COMPARE investigators have provided some of the first major insights into the comparative long-term differences in stent thrombosis rates between one and two years for different stent platforms."
"The two-year results presented today for the COMPARE trial and for the SPIRIT IV trial demonstrate impressive outcomes for XIENCE V compared to TAXUS Liberte and TAXUS Express, respectively," said Robert Hance, senior vice president, vascular, Abbott. "Both of these trials show the differences in the performance of these drug eluting stents and add to the ever-growing body of safety and efficacy data for XIENCE V – reinforcing why XIENCE V continues to be the market-leading drug eluting stent."
About The COMPARE Study
The COMPARE study is a physician-initiated "all-comers" trial sponsored by Maasstad Ziekenhuis of Rotterdam, the Netherlands. The study, designed to reflect real-world, everyday clinical practice, enrolled 1,800 patients in a single- center, prospective randomized (1:1) comparison of safety and efficacy of the XIENCE V™ Everolimus Eluting Stent System to the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System. The COMPARE trial was supported in part by an Abbott grant. All aspects of the trial were designed and conducted independent of Abbott.
About XIENCE V
Abbott's market-leading XIENCE V drug eluting stent is marketed in the United States, Europe, Japan and other international markets.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available online at www.xiencev.com or www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at www.abbott.com.
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