Abbott (NYSE: ABT) announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its XIENCE V(R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Japan is the second largest drug eluting stent market in the world after the United States, with approximately 200,000 stent procedures performed each year. The company plans to launch XIENCE V in Japan in the upcoming weeks, immediately following final reimbursement authorization.
"With today's approval, physicians in Japan will now have access to a next-generation drug eluting stent that offers outstanding ease of use and excellent clinical performance and safety. XIENCE V is the ideal combination as documented by the more than 16,000 patients who have been enrolled in the SPIRIT family of trials," said Robert Hance, senior vice president, vascular, Abbott. "Each aspect of XIENCE V's design, from the thin struts to the flexible delivery system to the drug and polymer, was carefully engineered for optimal deliverability and to improve safety and efficacy outcomes for patients compared to earlier generation stents. These attributes have made XIENCE V the market-leading drug eluting stent around the world, and we look forward to making XIENCE V available to physicians in Japan shortly."
"XIENCE V is flexible and easy to deliver through the coronary anatomy to the lesion site. These attributes combined with the strength of the safety and efficacy data supporting it give me confidence that XIENCE V is a true next-generation stent that has the potential to benefit heart patients in Japan," said Shigeru Saito, M.D., F.A.C.C., F.S.C.A.I., F.J.C.C., director, Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, and principal investigator for the SPIRIT III Japan Registry.
The outstanding data for XIENCE V includes clinically superior long-term efficacy and safety results in the primary endpoints of the pivotal trials, and among the SPIRIT family of trials. The SPIRIT III Japan Registry of 88 patients demonstrated similar angiographic and clinical results to the outstanding outcomes from the SPIRIT III U.S. trial. In the SPIRIT III Japan Registry, XIENCE V demonstrated a single-digit rate of major adverse cardiac events (MACE, 8.0 percent), and no cases of stent thrombosis (blood clots) out to one year. MACE is an important composite clinical measure of safety and efficacy outcomes for patients and is defined as cardiac death, heart attack (all myocardial infarction or MI), or ischemia-driven target lesion revascularization (ID-TLR).
In the SPIRIT III U.S. trial, XIENCE V demonstrated an impressive low rate of very late stent thrombosis with no additional events between two and three years, and a 43 percent reduction in the risk of MACE compared to the TAXUS(R) Express(2) Paclitaxel-Eluting Coronary Stent System (TAXUS) at three years (9.1 percent for XIENCE V vs. 15.7 percent for TAXUS, p-value=0.003)(1).
In SPIRIT IV, one of the largest randomized trials comparing two drug eluting stents, XIENCE V demonstrated a statistically significant 39 percent reduction in target lesion failure (TLF) compared to TAXUS at one year (3.9 percent for XIENCE V vs. 6.6 percent for TAXUS, p-value=0.0008)(1). TLF is a composite measure of important efficacy and safety outcomes for patients and includes cardiac death, target vessel MI and ID-TLR. XIENCE V also had an exceptionally low rate of stent thrombosis out to one year, with a 74 percent reduction in definite/probable stent thrombosis per the Academic Research Consortium (ARC) definition compared to TAXUS (0.29 percent for XIENCE V and 1.10 percent for TAXUS, p-value=0.004).
Additionally, in the investigator-initiated COMPARE trial of real-world patients, XIENCE V demonstrated significantly better outcomes in key safety and efficacy measures compared to the TAXUS(R) Liberte Paclitaxel-Eluting Coronary Stent System (TAXUS). At one year, XIENCE V demonstrated a statistically significant 31 percent reduction in MACE compared to TAXUS (6.2 percent XIENCE V vs. 9.1 percent TAXUS, p-value=0.023)(2), and a statistically significant 74 percent reduction in stent thrombosis compared to TAXUS (0.7 percent XIENCE V vs. 2.6 percent TAXUS, p-value=0.002)(2). In the COMPARE trial, MACE is defined as all death, non-fatal MI and target vessel revascularization.
More About XIENCE V
Abbott's market-leading XIENCE V is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure.
XIENCE V is built upon Abbott's market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.
In some geographies, Abbott supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(R) Everolimus-Eluting Coronary Stent System. PROMUS is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.
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 antiproliferative 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). Additional information about XIENCE V, including important safety information, is available online in Japanese at www.xiencev.jp, and in English at www.xiencev.com.
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.
About Abbott
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 more than 72,000 people and markets its products in more than 130 countries.
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(1) Event rates are based on Kaplan-Meier estimates; p-values based on log-rank test.
(2) Event rates are based on Kaplan-Meier estimates.